40487014 true Safe Administration of Medicines Intervention (SAM-I): a feasibility study of an intervention to de-implement unnecessary double-checking of medicines in hospital SAM-I 1. Are the systems for collecting our primary and secondary outcome measures compatible for use in WP4? 2. Can we improve the efficiency of observational tools for WP4? 3. Is the de-implementation intervention feasible and acceptable to frontline ward staff, and how long does it take? Why/why not? 4. Does the intervention require modifications prior to the main trial to ensure success? If so, what are they and how can they be integrated? 5. Under what conditions does a service become ready to de-implement double-checking (time span, appropriate personnel, infrastructure or policy changes, etc)? Background and study aims Double-checking a medicine before giving it to the patient is often used to reduce medication errors. However, there is no convincing evidence that it works. Nurses spend a lot of time double-checking (6.4 minutes per check), which is estimated to cost the NHS between £412 million and £1.28 billion per year. If double-checking reduces error and patient harm, then this might be time well spent. But evidence shows that double-checking can harm patients by causing delays to them getting critical medicines. This study aims to assess the feasibility, acceptability, and readiness for implementing a co-designed de-implementation intervention that aims to reduce routine double-checking and support safe single-checking of medicines. The study will run over 12 months across three NHS hospital trusts and include six clinical services. Who can participate? Staff members over the age of 18 years employed within a participating ward/service during the study period (e.g., permanent, bank or agency workers) and directly involved in preparing and/or administering medications What does the study involve? The study involves assessing the feasibility and acceptability of implementing a ward-level de-implementation intervention (the SaSI-MEDs Observation Tool) to reduce routine double-checking of medicines and support safe single-checking and to test the study procedures and outcome measures required for a future definitive randomised controlled trial. We will undertake 5-7 observation sessions (lasting about 4-6 hours each) shadowing consenting nurses involved in medication administration, positioning themselves so they can observe practice without obstructing care delivery. The focus of the observation will be on medication administration processes rather than individual staff performance. Observations will take place before and after implementation. All staff involved in medication preparations and/or administrations will also be invited to complete a questionnaire to explore views on single checking and nursing care activities. What are the possible benefits and risks of participating? Although there are no immediate benefits for the nurses participating in the study, it is hoped that the findings of this work will lead to improvements in safely administering medicines in hospitals. If we find that double-checking is no safer than single-checking, it could lead to changes in policy that could reduce double-checking in certain circumstances. This could reduce nursing workload and free up time for staff to carry out more patient-centred tasks and potentially improve the quality of care. We do not expect any disadvantages or risks to being involved. It is important that you understand that we are interested in assessing what is feasible and acceptable to change for safer medication administration. We are not examining your individual knowledge or skills. There is a possibility that you will experience discomfort when being observed. To minimise this, we will try to ensure you are familiar with the research nurse and have had the opportunity to ask questions. Where is the study run from? The study is run from Bradford Teaching Hospitals NHS Foundation Trust and York Trials Unit (University of York) (UK) When is the study starting and how long is it expected to run for? September 2026 to April 2028 Who is funding the study? The National Institute for Health Research (NIHR) Programme Grants for Applied Research (UK) Who is the main contact? 1. Chief Investigator: Professor Beth Fylan, b.fylan@bradford.ac.uk 2. Programme Manager: Dr Lynn McVey, lynn.mcvey@bthft.nhs.uk 3. Senior Research Fellow: Dr Katherine Jones, katherine.jones@bthft.nhs.uk Observed medication administration errors the SAM-I Case Note Review Form pre- (month [M] 0) and post-implementation (M8-10), recording observed errors where a double-check would previously have been mandated by policy. This will be recorded as 'yes' or 'no' per observed medication administration. 1. Nurse attitudes to single-checking measured using the validated Single Checking and Administration of Medications Scale (SCAMS-II) at pre- (M0) and post-implementation (M8-10) 2. Omission of care measured using the care left undone scale at pre- (M0) and post-implementation (M8-10) 3. Double-checking practices measured using the SAM-I Observational Tool at pre- (M0) and post-implementation (M8-10) 4. Service readiness for single checking measured using a checklist and single binary measure at pre-implementation (M0) 5. Length of patient stays measured using routine data collection from electronic Prescribing and Medication Administration systems (ePMA) at post-implementation (M8-10) 6. Reported patient safety incidents (medication-related) measured using routine data collection from Local Risk Management Systems (LRMS) at post-implementation (M8-10) 7. Time spent implementing checks measured using the SAM-I Observational Tool at pre- (M0) and post-implementation (M8-10) 8. Delays in time-critical administrations measured using routine data collection from electronic Prescribing and Medication Administration systems (ePMA) at post-implementation Ethics approval required London - Queen Square Research Ethics Committee

2 Redman Place, Stratford

London United Kingdom E20 1JQ 26/LO/0402 10.1186/ISRCTN40487014 367872 CPMS: 74129, NIHR: 206796 367872 74129 206796 Non-randomized study Interventional Non randomised study Treatment 2028-04-01T00:00:00.000Z United Kingdom England RRDN Yorkshire and Humber

St. James's University Hospital Beckett Street

Leeds England LS9 7TF false Ward inclusion criteria: 1. NHS-funded inpatient wards within a participating NHS Trust 2. Wards where medicines administration is frequent and routinely undertaken by nursing staff 3. Wards where double-checking of medicines is embedded within local policy and/or established practice 4. Wards able to support implementation of the intervention, including staff training, policy updates and ward-level engagement activities 5. Wards able to support feasibility data collection, including structured observation of medication administration and access to relevant routine data sources (e.g., ePMA and incident reporting systems) Staff participant inclusion criteria: Staff will be eligible to participate in observation and qualitative evaluation components if they meet the following criteria: 1. Employed (permanent, bank or agency) within a participating ward/service during the study period 2. Directly involved in medicines preparation, administration or supporting the double-checking process (e.g., registered nurses, nurse associates) 3. Aged 18 years or over, consistent with their professional role 4. Willing and able to provide informed consent to participate in observations and other evaluation activities (e.g., questionnaires or interviews where applicable) We will aim to recruit staff representing a range of professional seniority and experience (from newly qualified to senior nurses), diverse ethnic backgrounds, and both substantive ward staff and those working bank or agency shifts to reflect the typical ward workforce. Patients: With CAG approval in place, case note review will be conducted for patients whose medication administration episodes are observed. This will allow comparison between observed practice and prescribed medicines without requiring individual patient consent in order to calculate primary and secondary outcomes. Where paediatric or neonatal wards are included, this may involve review of records for patients under the age of 18 years. Only the minimum necessary patient-identifiable information will be temporarily accessed for linkage purposes, in accordance with CAG approval and data governance procedures. Adult All 1080 0 Patients: Patients will not be directly recruited; however, case note review will not be undertaken where: 1. The medication administration episode was not observed as part of the study 2. The patient (or parent/guardian, where applicable) has exercised their right to opt out of the use of their data for research purposes Only the minimum necessary information will be accessed under CAG approval, in line with approved governance procedures. 2026-09-01T00:00:00.000Z 2028-04-01T00:00:00.000Z Public health Other The intervention is a structured, ward-level approach to reducing routine double-checking and support safe, single-checking for medication administration. It targets ward-level policies and systems, staff motivation, capability and opportunity, norms, and practical workflow processes checking behaviours. Behavioural Data sharing statement to be made available at a later date Protocol

a46d4b4d-ebaa-4fb7-91bc-267ae7694203 2c670fa0-3d8a-4d1c-aa32-f691ee7fee10 d166b709-f3a5-4f13-89a7-4630997e765e 661d1350-4a14-4c34-9521-229a4569186d No Participant information sheet 49920_PIS_V1.2_25Jun2026.pdf 921c416f-9088-4d74-b281-8f483154b41d true application/pdf 289727 1f91b6a3ca743d2d8af6f78784234450 Protocol file 49920_Protocol_V1.2_01Jun2026.pdf c9d29f44-301d-4653-b30e-407636b5daf6 true application/pdf 758551 be8a28e50abd7d33439c10ae52b2fcf7 Beth Fylan https://orcid.org/0000-0003-0599-4537 Principal investigator Scientific

University of Bradford, Richmond Building, Richmond Road

Bradford United Kingdom BD7 1DP +44 (0)1274236952 B.Fylan@bradford.ac.uk Public Lynn McVey https://orcid.org/0000-0003-2009-7682 Public

Bradford Teaching Hospitals NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane

Bradford United Kingdom BD9 6RJ - lynn.mcvey@bthft.nhs.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 75400619 true The In Real Life (IRL) Trial: a cluster-randomised controlled trial of a school-based social media reduction intervention versus treatment-as-usual control in secondary school pupils (aged 12–15) in Bradford, UK, and its effects on anxiety (RCADS-25) and secondary outcomes IRL (In Real Life) 1. To estimate the effect of a social media restriction intervention on anxiety (primary outcome) as well as secondary outcomes using a usual-treatment control condition among adolescents in academic years 8, 9, and 10. 2. To explore possible mechanisms underlying the effect of social media restriction. Background and study aims Social media use among children and adolescents has been linked to harms including bullying, sexual risks, and mental health problems. Adolescence is a sensitive period for mental health, with increased risk-taking, ongoing brain development, and the onset of many conditions. Observational studies suggest heavier social media use is associated with more mental health symptoms, but scientific authorities in the UK and US have concluded the average causal effect is unclear. This study is evaluating the effects of an intervention designed to reduce social media media use on mental health among secondary school pupils (academic years 8–10, corresponding to ages 12-15 years). We will explore potential mechanisms underlying these effects. Who can participate? Students enrolled in year 8, 9, or 10 (September 2026), corresponding to ages 12-15 years, at participating secondary schools. What does the study involve? School year groups (academic years 8–10) will be randomly allocated to either (i) a social media restriction app, limiting use to 1 hour per day between 7am and 9pm, or (ii) a treatment-as-usual control condition where the app tracks screen time but applies no restrictions. The intervention will last 6 weeks. Participants will complete a self-reported questionnaire on topics including mental health, bullying, and sleep at baseline (week 0) and follow-up (week 6). Around 30 participants in the intervention group will also take part in qualitative interviews to share their experiences and explore how reducing social media use may affect mental health. What are the possible benefits and risks of participating? Benefits: 1. Possible benefits of the intervention itself (a benefit in terms of mental health). 2. Financial compensation. Risks: 1. Reduced opportunity for social engagement, support, or fear of missing out due to reduced use of social media. 2. Bullying due to participants being left out of social events. 3. Distress experienced during quantitative or qualitative data collection. Where is the study run from? Bradford Teaching Hospitals NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? September 2026 to May 2027 Who is funding the study? 1. The Wellcome Trust (UK) 2. National Institute for Health Research (UK) Who is the main contact? Dr Dan Lewer, borninbradford@bthft.nhs.uk Anxiety the Revised Child Anxiety and Depression Scale (RCADS-25) anxiety subscale self-report survey week 0 (baseline) and week 6 (follow-up) Symptoms of depression the Revised Children's Anxiety and Depression Scale (RCADS) depression subscale self-report survey week 0 (baseline) and week 6 (follow-up) Mental wellbeing the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) self-report survey week 0 (baseline) and week 6 (follow-up) Ethics approval required East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

2 Redman Place

London United Kingdom EC20 1JQ 26/EE/0127 10.1186/ISRCTN75400619 370130 CPMS: 73987, NIHR: 205448, 337689/Z/25/Z, BTHFT 3191 370130 73987 205448 337689/Z/25/Z BTHFT 3191 Interventional Randomized controlled trial Blinded (masking used) Active Parallel Prevention Not applicable 2027-05-31T00:00:00.000Z United Kingdom England Bradford Teaching Hospitals NHS Foundation Trust

Bradford Royal Infirmary Duckworth Lane

Bradford England BD9 6RJ RAE@2.16.840.1.113883.2.1.3.2.4.18.48 true Updated 29/09/2026: Current key inclusion criteria as of 13/08/2026: 1. Currently enrolled in a secondary school 2. In academic year 8 - 10 3. Can speak and read English Previous key inclusion criteria: 1. Currently enrolled in a secondary school 2. In academic year 8 - 10 3. Owns a smartphone (or regularly uses a specific smartphone that can be used in the research) 4. Can speak and read English Child 12 Years 15 Years All 4500 0 No specific exclusion criteria (all school types and young people will be eligible) 2026-09-07T00:00:00.000Z 2027-03-31T00:00:00.000Z Mental health in healthy young people Mental and Behavioural Disorders Study design: This will be a parallel-arm cluster randomised trial in which school year groups will be randomised to two conditions: (1) an intervention involving a smartphone app designed to reduce social media screen time; (2) a treatment-as-usual control state. The primary outcome will be self-reported anxiety, with other outcomes measured by self-report and the app. We will work with 10-12 secondary schools and randomise 30-36 year groups (academic year groups 8-10 only), with baseline measurements taken when participants join the study and follow-up measurements after six weeks. Intervention arm: The intervention will be a smartphone app for Android and iOS (iPhone), which will limit participants’ use of a pre-defined list of social media and internet browser apps. The app will limit social media through two mechanisms: (i) a daily time ‘budget’ across all linked social media apps and (ii) a ‘curfew’ that prevents linked app use during nighttime hours. Based on coproduction with teenagers, we are planning a daily budget of 1 hour and a curfew from 9 pm to 7 am. We will deliver the intervention over 6 weeks. Control arm: Participants download the same app but receive no active intervention components and the app is only used for passive data collection. Randomisation: School year groups will be randomised in a 1:1 ratio to either the intervention or a treatment-as-usual control condition. Year groups will be randomised within schools, meaning each participating school will have at least one intervention and one control year group. Qualitative research: We will also conduct semi-structured interviews with a purposive sample of ~30 intervention participants during the final week of the intervention and at 6-month follow-up. In these interviews we will explore participants’ experiences and mechanisms by which the intervention may influence mental health outcomes. Behavioural The full dataset will be securely stored at Bradford Teaching Hospitals NHS Foundation Trust, with access restricted to IT staff and named researchers (the Chief Investigator, or another senior member of staff if the Chief Investigator leaves). Personal identifiers will be deleted at the earliest opportunity. An analysis dataset will be available upon request using the Born In Bradford data request process: https://borninbradford.nhs.uk/our-data/how-to-access-data/. Data sharing will be subject to an approved analysis plan and data sharing agreement. Available on request Protocol

69da24f6-75f0-4012-b06f-6ecc5bb8cfd6 bdd0a681-de1b-4d1c-afd9-1366e4aa5578 4490397e-b6bc-4614-a9b9-0bd914b346f6 a6b0ed33-75cd-476e-b964-d4f1f137b8d7 c36b5236-1d73-49a4-95cc-b8638c8d7a22 Yes Protocol file ISRCTN75400619_Protocol_v1.3.pdf ecf93d29-c8bb-4b97-a368-d9382ef48f6f true application/pdf 299182 a78c3ca7a064b840428fa9944952089e Dan Lewer https://orcid.org/0000-0003-3698-7196 Public Scientific Principal investigator

Born in Bradford Office Bradford Institute For Health Research Bradford Royal Infirmary Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 (0)1274 274474 borninbradford@bthft.nhs.uk Public Amy Orben https://orcid.org/0000-0002-2937-4183 Principal investigator

MRC Cognition and Brain Sciences Unit University of Cambridge 15 Chaucer Road

Cambridge United Kingdom CB2 7EF +44 (0)1223 355294 info@mrc-cbu.cam.ac.uk Public Bradford Teaching Hospitals NHS Foundation Trust https://ror.org/05gekvn04 Non-commercial Wellcome Trust http://dx.doi.org/10.13039/100010269 National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 79680371 true A feasibility study of the Shared Safety Net Action Plan (SSNAP): a safety-netting intervention that engages patients to support earlier diagnosis of cancer in general practice SSNAP To assess: 1. Whether the delivery of SSNAP is feasible in general practice; 2. Whether SSNAP is acceptable to patients, their families and staff; 3. Whether patient recruitment and follow-up is feasible in general practice; 4a. What outcomes would demonstrate whether SSNAP successfully supports communication and shared decision-making around uncertainty; 4b. What outcomes would demonstrate SSNAP improves patients’ clinical outcomes; 5. How surgeries adapt SSNAP for local use. Background and study aims When doctors aren’t sure what’s causing a patient’s symptoms, they often use a process called “safety-netting.” This means they ask patients to keep an eye on their symptoms and come back if things don’t improve. It’s especially important when symptoms could be an early sign of something serious, like cancer. But sometimes patients forget what they were told or aren’t sure what to look out for. This study is testing a new tool called the Shared Safety Net Action Plan (SSNAP). SSNAP helps patients understand what symptoms to monitor, how long to monitor them, and when to return to the doctor. It also helps GP practices follow up with patients. The aim is to see if SSNAP makes safety-netting clearer and more helpful for patients and staff. Who can participate? Adult patients who visit their GP with vague symptoms that might be linked to cancer—such as tiredness or unexplained weight loss—may be invited to take part. Their family members and GP staff may also be involved. What does the study involve? Patients and families will be asked to fill in questionnaires about their experience of the GP consultation. Some patients who use SSNAP will also be invited to talk to researchers about how it worked for them. GP staff will be interviewed about their experience using SSNAP. The study will also collect data on how often SSNAP is used and what impact it has. What are the possible benefits and risks of participating? Taking part may help patients feel more confident about managing their symptoms and knowing when to seek help. It could also improve communication between patients and their GP. There are no known risks to taking part, and participation is voluntary. Where is the study run from? Bradford Teaching Hospitals NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? March 2025 to April 2028 Who is funding the study? National Institute for Health and Care Research (NIHR). Who is the main contact? Lynn McVey, Lynn.McVey@bthft.nhs.uk Diagnosis of cancer at any stage is measured using anonymised electronic health record data from SystmOne at the end of WP1 (months 5-6 of the study) and in WP3 (months 16-17) 1. Time to re-attend, anonymised data will be collected twice from SystmOne: at the end of WP1 (months 5–6 of the study) and in WP3 (months 16–17) 2. Referral(s) for follow-up diagnostic tests, anonymised data will be collected twice from SystmOne: at the end of WP1 (months 5–6 of the study) and in WP3 (months 16–17) 3. Number of re-attendances & DNAs over intervention period, anonymised data will be collected twice from SystmOne: at the end of WP1 (months 5–6 of the study) and in WP3 (months 16–17) 4. Number of patients re-booking appointments, anonymised data will be collected twice from SystmOne: at the end of WP1 (months 5–6 of the study) and in WP3 (months 16–17) 5. Number of occasions intervention used (intervention surgeries) or would be used (control surgeries), anonymised data will be collected twice from SystmOne: at the end of WP1 (months 5–6 of the study) and in WP3 (months 16–17) 6. Willingness of surgeries to be randomised, data collected during interviews and focus groups with participating staff during WP3 (months 16 and 17 of the study) 7. Willingness of staff to initiate SSNAP with patients, data collected during interviews and focus groups with participating staff during WP3 (months 16 and 17 of the study) 8. Number of interviews/ focus groups/questionnaires completed, to be determined when these have taken place, around month 21 9. Intervention patients’/families’ perspectives on SSNAP feasibility & acceptability, collected in patient/carer questionnaires and interviews during WP2 and WP3 (months 8–17 of the study) 10. Consultation satisfaction for intervention & control patients/families, collected in patient/carer questionnaires and interviews during WP2 and WP3 (months 8–17 of the study) 11. Number of eligible patients, anonymised data will be collected twice from SystmOne: at the end of WP1 (months 5–6 of the study) and in WP3 (months 16–17) 12. Number of patients followed-up, anonymised data will be collected twice from SystmOne: at the end of WP1 (months 5–6 of the study) and in WP3 (months 16–17) 13. Intervention staff perspectives on SSNAP feasibility & acceptability, including feasibility of data extraction and linkage, data will be collected from staff in interviews and focus groups in WP3 (months 16–21 of the study) Ethics approval required Leeds East REC

2 Redman Place, Stratford

London United Kingdom E20 1JQ 25/YH/0163 10.1186/ISRCTN79680371 345898 CPMS: 63265, NIHR: 208819 345898 63265 208819 Interventional cluster randomized Interventional Cluster randomised trial Other 2028-04-30T00:00:00.000Z United Kingdom England Yorkshire and Humber RRDN

St. James's University Hospital Beckett Street

Leeds England LS9 7TF Carer Health professional Patient Patient/carer inclusion criteria for intervention: 1. Patients aged 18 and over presenting with non-specific symptoms which could indicate cancer, who have capacity to decide on their own medical treatment. 2. Patients aged 18 and over presenting with non-specific symptoms which could indicate cancer, who do not have capacity to decide on their own medical treatment, but who are accompanied in the consultation by a family member or informal carer (consultee). 3. Family members or informal carers aged 18 and over who accompany SSNAP-coded patients in consultations. Patient/carer inclusion criteria for questionnaires: 1. Patients aged 18 or over in intervention surgeries who have received SSNAP or who were recorded as eligible to receive SSNAP in control surgeries. 2. Family members/informal carers aged 18 and over who accompany patients in consultations where SSNAP was used in intervention surgeries or where the patient was recorded as eligible to receive SSNAP in control surgeries. Patient/carer inclusion criteria for interviews: 1. Patients aged 18 or over in intervention surgeries who have received SSNAP. 2. Family members/informal carers aged 18 and over whose relative/significant other has received SSNAP in an intervention surgery. Staff inclusion criteria (intervention, interviews, focus groups) 1. All staff in participating surgeries with a safety-netting role (clinical, management/ administrative). Mixed 18 Years 100 Years All 204 0 Patients/carer exclusion criteria for intervention: 1. Young people and children aged under 18 years. 2. Patients aged 18 and over who do not have capacity to consent to their own medical treatment and who either are not accompanied by a family member or informal carer (consultee), or the consultee does not agree to receiving the SSNAP plan. 3. Patients who have opted out of data sharing. Patient/carer exclusion criteria for questionnaires & interviews: 1. Patients who meet the inclusion criterion but for whom participation in questionnaires or interviews could cause distress or confusion, including patients without capacity to consent to the research or patients who are too ill to participate (e.g. at the end of life). 2. Patients, family members/informal carers aged less than 18 years. 3. Family members/informal carers of patients who received SSNAP (in intervention surgeries) or were recorded as eligible to receive SSNAP (in control surgeries) but passed away before the invitation to complete a questionnaire is circulated, so as not to cause unnecessary distress. Staff exclusion criteria: 1. Staff not involved in safety-netting processes. 2026-04-13T00:00:00.000Z 2027-07-31T00:00:00.000Z Cancer Cancer This feasibility study takes the form of a cluster randomised controlled trial. Participants will be adult patients consulting with a primary care practitioner about non-specific symptoms that could be a sign of cancer; adult family members or informal carers who accompany eligible patients in consultations; and staff in participating surgeries with a safety-netting role (clinical, management/administrative). Work package 1 (months 1–6): We will work with six GP surgeries in Bradford, Airedale, Wharfedale and Craven that use the primary care electronic patient record SystmOne and have data sharing agreements in place with Connected Bradford, a whole system data linkage service (<https://bradfordresearch.nhs.uk/connected-bradford/>). Surgeries will be randomised via block randomisation, site initiation visits will take place and surgery staff will be trained (intervention and control training will differ, with intervention surgeries being trained in how to use the SSNAP tool inclusively). SSNAP will be installed on SystmOne in intervention surgeries. In months 5–6, clinicians in participating surgeries will identify through coding in SystmOne adult patients presenting with non-specific symptoms who are eligible for SSNAP. The research team will obtain anonymised data relating to our outcome measures (see A57, A58) for these patients (provided they have not opted out of data sharing) through Connected Bradford to establish a baseline, including anonymised demographic data. As part of a data collection feasibility exercise, staff in two surgeries will also extract the data themselves to test whether this is feasible, but these identifiable data will not be forwarded to researchers. This will inform the feasibility of data collection for a substantive trial for which we will recruit surgeries which do not have data sharing agreements with Connected Bradford. Work package 2 (months 7–15): In intervention surgeries, digital or paper SSNAP will be used as part of routine safety-netting procedures. Using SSNAP, clinicians and patients with non-specific symptoms will agree a plan that specifies which symptoms the patient will monitor, over what time-period, and in what circumstances patients should return. Clinicians will populate the SSNAP template in SystmOne, creating a safety-netting record within patients' electronic notes. Where use of paper SSNAP is more appropriate for patients (see also A33-1), clinicians will also personalise the paper SSNAP form for patients to take away with them. Where digital SSNAP is appropriate, they will generate via SystmOne a personalised letter and a diary for the patient to monitor their symptoms, which will be sent to the patient by text or email. Clinicians can set reminders to contact patients at different priority levels, which appear on the patient home screen whenever a patient record is retrieved, and/or scheduled tasks can be set as reminders, allocating tasks such as contacting patients to specific recipients such as surgery administrators. Clinicians from control surgeries will carry out their usual safety-netting procedures and continue to code patients as eligible for SSNAP in SystmOne. Surgeries will display posters informing patients that the surgery is taking part in research about care of patients who have consulted a clinician with non-specific symptoms and they may be contacted at a future date about this, although they're free not to respond. All patients who have received SSNAP (in intervention surgeries) or who were recorded as eligible for SSNAP (in control surgeries) will be contacted by surgery staff around four weeks after initial consultations. They will be informed that researchers are conducting a study about care of patients who have consulted a clinician with non-specific symptoms where a diagnosis has not yet been reached and invited to complete, with consent, a questionnaire measuring consultation satisfaction (online or post). The questionnaire for people in the intervention arm will ask whether they would be willing to be contacted by the research team about a telephone/online interview (purposively sampled). Researchers will send an information sheet to those patients/carers who indicate an interest in an interview and informed consent will be taken before interviews begin. Patients and carers will be asked in the interviews about SSNAP's feasibility, acceptability, how they used and engaged with it, what they thought about it and how it might best be refined. Questions will be informed by the SSNAP logic model (appended to the protocol). Towards the end of the intervention period, Connected Bradford will provide the same data for patients coded for SSNAP in intervention period as in the baseline period (for patients who have not opted out of data sharing) and anonymised data will be forwarded to researchers. Work package 3 (months 16–30): Researchers will interview staff from each surgery (clinicians, managers, administrators), and will also conduct a staff focus group with staff in each surgery. Interviews and focus groups with staff from control surgeries will assess issues relating to trial design, e.g. willingness of surgeries to be randomised. Those with staff from intervention surgeries will explore SSNAP's feasibility and acceptability, how and why they used it, what factors influenced its adoption and how it might best be refined/further developed. Questions will be informed by the SSNAP logic model (appended to the protocol). Staff involved in delivering SSNAP in intervention surgeries will be asked during interviews and focus groups to complete the System Usability Scale to provide evidence of SSNAP's acceptability. Patient questionnaires and interviews will be completed. Quantitative and qualitative data will be analysed and synthesised (see A62 for methods of analysis). In agreement with our trial steering committee, it will be determined if the intervention should progress to trial and study outputs will be prepared, namely refined paper and digital versions of SSNAP; refined logic model and programme theory; protocol for the substantive trial; and implementation guide with associated training tools. Dissemination will take place through the final trial report; at least two journal articles in international, peer-reviewed open access journals; a conference presentation and through research networks. We will explore routes to wider implementation with our patient and public involvement group, key stakeholders and the steering committee. Behavioural The datasets generated during and/or analysed during the current study will be available upon request from Connected Bradford cbradford@bthft.nhs.uk; type of data are shared linked primary care and secondary care data; data will become available for 10 years or the length of the CB programme; researchers complete a data access application and this is reviewed by the programme manager and considered by Connected Bradford Board; current CB data access process, data are fully anonymised, Connected Bradford REC ref: 22/EM/0127. Qualitative datasets are available on request from Dr Lynn McVey, contact details above. Anonymised data may be shared from interviews and focus groups for qualitative analysis for a maximum of 5 years; participant consent obtained; SSNAP REC ref: 25/YH/0163. Available on request f0851970-a8b2-4c4b-961a-e3c205f5a3b9 62d29a2f-fb3d-48eb-ad00-6574268e112f 69c9b2db-8c32-485e-830b-98ed0cd596f4 Yes Lynn McVey https://orcid.org/0000-0003-2009-7682 Public Scientific Principal investigator

Yorkshire Quality and Safety Research Group, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Duckworth Lane

Bradford United Kingdom BD9 6RJ - Lynn.McVey@bthft.nhs.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272 32222362 true Evaluating the indoor environment, health, carbon emission, economic outcomes of retrofitting social housing properties to improve energy efficiency in a low-income multi-ethnic population: a quasi-experimental study with process evaluation Healthy Homes We aim to assess the impact of improving the energy efficiency of social housing ('retrofit') on indoor environmental quality (including temperature, relative humidity, damp/mould, and indoor air quality (e.g. NO2, PM2.5, carbon dioxide [CO2]), health, and environmental and economic impacts. We will explore trade-offs in indoor conditions and other potential unexpected consequences, along with contextual and system factors which affect implementation and resident experience. Our research questions (RQ) are: RQ1: What is the impact of retrofit up to 12 months post-retrofit on: A) temperature, B) thermal comfort, C) indoor air quality (focusing on NO2, PM2.5, and air change rates) D) risk of damp/mould; E) energy use, F) self-reported satisfaction and mental and respiratory health? RQ2: A) What is the impact of retrofit up to 5 years post-retrofit on adult residents’ acute health care use related to i) mental health, ii) respiratory health, and iii) cardiovascular health?; B) Are there differential impacts for vulnerable groups (those with pre-existing health issues)? RQ3: What is the impact of retrofit on short- and long-term A) exposure to indoor environmental conditions and carbon emissions (3A), and B) health and economic impacts? (3B) RQ4: A) How was the retrofit implemented, and what system, and wider contextual factors influenced the implementation? B) Was the implementation as intended (from the perspective of residents and other stakeholders) and are there any unexpected consequences from implementation? Background and study aims The quality of our homes can have a big impact on our health. Cold, damp, or poorly ventilated homes can lead to problems like mould, indoor air pollution, and stress, which may increase the risk of heart and lung conditions. Making homes more energy-efficient—known as retrofitting—can help improve health, reduce energy bills, and lower carbon emissions. However, if not done carefully, retrofitting could also reduce fresh air and make damp or pollution worse. This study is working with a large social housing provider in Bradford to find out how retrofitting affects people’s health, indoor air quality, and whether it offers good value for money. The results will help guide future housing improvements to benefit both people and the environment. Who can participate? Residents living in selected social housing properties in Bradford may be invited to take part. Some homes will be retrofitted, and others will be used for comparison. What does the study involve? If you take part, we may install small sensors in your home to measure air quality, temperature, and humidity. You’ll be asked to complete short surveys about your health, comfort, and energy use at three different times. In some homes, we’ll also measure mould and how windows are used for ventilation. A small number of residents will be invited to take part in interviews to share their experiences. What are the possible benefits and risks of participating? Taking part could help improve understanding of how to make homes healthier and more comfortable. It may also help shape future housing policies. There are no major risks, but some people may find the surveys or sensors slightly inconvenient. All information will be kept private and secure. Where is the study run from? Bradford Teaching Hospitals NHS Foundation Trust in partnership with a major social housing provider (UK) When is the study starting and how long is it expected to run for? July 2025 to December 2029 Who is funding the study? National Institute for Health and Care Research (NIHR) (UK). Who is the main contact? Dagmar.Waiblinger@bthft.nhs.uk Temperature measured via the AirGradient sensor in 5-minute periods continuously from baseline until monitoring ends in Spring 2027 1. Indoor air quality (PM2.5, CO2, NO2, relative humidity) measured via the AirGradient sensor in 5-minute periods continuously from baseline until monitoring ends in Spring 2027 2. Energy use measured via energy meter readings at four time periods: the start and end of winter 2025/2026 and start and end of winter 2026/2027 3. Mould concentrations measured via a mould sensor in winter 2025/2026 and winter 2026/2027 (in a subset of homes) 4. Resident thermal comfort and satisfaction measured via questionnaire in winter 2025/2026 and in winter 2026/2027 5. Resident self-reported respiratory and mental health via questionnaire in winter 2025/2026 and in winter 2026/2027 Ethics approval required Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

NHSBT Newcastle Blood Donor Centre, Holland Drive

Newcastle-upon-Tyne United Kingdom NE2 4NQ 25/YH/0081 10.1186/ISRCTN32222362 347237 CPMS: 64093, NIHR: 165582 347237 64093 165582 Observational cohort study Observational Cohort study Quality of life 2029-12-31T00:00:00.000Z United Kingdom England Bradford Teaching Hospitals NHS Foundation Trust

Bradford Royal Infirmary Duckworth Lane

Bradford England BD9 6RJ RAE@2.16.840.1.113883.2.1.3.2.4.18.48 Patient WP1 1. Homes managed by Incommunities, with energy performance certificate EPC) rating less than ‘C’ and identified for retrofitting 2. Eligible homes will have retrofitting scheduled from March to October 2026 (intervention) Or after March 2027 (Control group). Ideally the control homes are a close match to the intervention homes in building age, type, and EPC 3. Residents of eligible home able to give informed consent and are 18 years or over WP4 Interviews with resident 1. Participants who consented to WP1 and whose household is part of the intervention group 2. After a participant of such a household consented, other residents with minimum age 18 years of the same household will become also eligible , if they are able to give informed consent Non-resident Stakeholder interviews 1. Participants over the minimum aged of 18 years and have consented to be interviewed 2. Participants involved in social housing and delivering good indoor air quality Peer Researchers 1. Participants over the age of 18 years and consented to be part of study 2. Participants who belong to the same community where the research is taking place 3. Able to speak English well (additional languages welcomed) Mixed 18 Years 99 Years All 430 0 WP1 1. Households which are not scheduled for retrofitting according to the required timeline 2. Language barrier that can not be overcome with support of bilingual research assistants 3. Lack capacity for informed consent WP4 Resident Interviews 1. Households which are not scheduled for retrofitting according to the required timeline 2. Lack capacity for informed consent 3. Language barrier that can not be overcome with support of bilingual research assistants Non-resident stakeholder interviews 1. Not involved in social housing or air quality 2. Lack capacity for informed consent 3. Language barrier that can not be overcome with support of bilingual research assistants Peer researchers 1. Lack capacity for informed consent 2. Unable to speak English well 2025-07-15T00:00:00.000Z 2026-01-31T00:00:00.000Z Public Health, Persons with potential health hazards related to socioeconomic and psychosocial circumstances Other The Healthy Homes project is structured into four work packages (WPs) with both quantitative (WP1, WP2, WP3A + 3B) and qualitative (WP4) methods. WP1 and WP4 will require engagement with the public, recruitment/taking consent and data collection whilst WP2 will carry out secondary data analysis on the Connected Bradford dataset. WP3A utilises data collected as part of WP1 in order to model the changes in indoor conditions and energy/carbon exposures for a range of housing archetypes. WP3B is a health economic evaluation which utilises findings from WP3A to model the longer-term economic, productivity, and health impacts. Therefore, the methodology in the following will focus on WP1 and WP4. WP1: Residents of homes of interest will be made aware that they are eligible to take part in the study, information will be sent through Incommunities or directly to the household and raising awareness and engagement within the community. Potential participants will be able to express their interest through various channels: either by phone, email, online, post, face to face and will provide their contact details. Potential participants that have previously consented to be part of one of our Born in Bradford cohorts and are identified as living at an eligible address, can be contacted directly (phone or letter) as they have consented to contact for further studies. The Healthy Home team will contact interested residents and discuss their participation and ensure that they have access to the participant information sheet. A home visit will be arranged with residents who would like to take part at a convenient date and time. At the first study visit: The fieldworker will complete the consent form with the resident in the household that will complete the baseline questionnaire (Survey 1) and subsequent questionnaires. The baseline questionnaire will be completed as part of the visit. An air pollution sensor (AirGradient) will be installed in the main living area ensuring that the sensor's own internet connection is working. Ideally, monitoring will continue until the sensor is picked up 18 to 21 months later in March 2027 (from set up in the 3rd quarter of 2025). Participants will receive monthly vouchers (£20) each month of the monitoring period. The participant will receive a contact schedule considering his/her contact preferences. Subsequent questionnaires: Participants will receive three additional questionnaires to complete, roughly each about 6 months apart, covering the Winter 2025/26 (Survey 2), Summer 2026 (Survey 3) and Winter 2026/2027 (Survey 4) periods. Questionnaires will be deployed according to participant preferences as an online link via email, in paper form, over the phone or as part of a home visit. Energy meter readings: We will collect energy meter readings before and after each winter period (e.g. 4 measurements in total). As much as possible we will tie these readings in with existing scheduled contacts. We give participants the option to take the reading themselves or to be taken by the fieldworker. Additional measurements (sub-sample): Mould sensor measurement: we may ask a smaller number of participants at the first visit whether they would agree to mould measurements at different time points. We will confirm with the participant each time that they are still happy with a repeat measurement. Measuring ventilation: we may ask participants whether they would be happy to accommodate window sensors on the windows in the living room for periods of time, for example in the winter. We will provide further information before any deployment and confirm that the participant is happy to have these installed. We aim for that visits for installation or de-installation to coincide with scheduled contacts, for example, subsequent questionnaires, mould sensor measurements and/or delivery of voucher. WP4: Interviews Participants of the intervention group will be asked at the first visit whether they would be happy to receive information about interviews carried out as part of WP4. Interested participants will receive further participant information in the winter period following recruitment. Up to 20 participants will become part of this sample and will sign a separate consent form prior to the interview. The interview will be conducted by a researcher using an interview guide and will take place at the participants home, or online, according to participant preferences. A further interview will take place one year later after the retrofitting has taken place. Participants will receive a £20 voucher for each interview. 10 non-resident stakeholders will also be interviewed. These will be those involved in social housing and delivering good indoor air quality and will be recruited through key contacts and snowball sampling. They will sign a separate consent form. The interviews will be conducted by a researcher of the Healthy Homes team using a different interview guide at a community venue, or online. These interviews will take place at two points, these are planned for Summer 2026 and Spring 2028. WP4-Peer Research 10 Peer-researchers will be recruited by one or two community organisations. If they wish to be part of the study, they will sign a consent form. They will then undertake some training and work with the research team to design a study (this in unknown at present but could include photographs, questionnaires, mapping, audio recordings, workshops). Each peer researcher will collect data from 10 residents, in phase 1 and 10 residents in phase 2 (12-18 months later). We will provide the ethics committee with further details of these activities as part of an amendment, prior to this element of the work starting. Other Quantitative data collected in this study will be available as part of the Born in Bradford repository. Data will be cleaned prior to availability. All data collected have been granted ethical approval and participant consent for its continued availability. Data requests are made to the BiB executive using the form available from the study website: http://www.borninbradford.nhs.uk (please click on ‘Our Data’ and ‘How to Access Data’ to access the form and guidance). All requests are carefully considered and accepted where possible. Available on request Stored in publicly available repository

Study website Migrated from study website field

6e32c2bd-c636-4ee9-8548-dca3df3e20d5 63628c2a-3cf6-4af0-902c-9566949ee5f4 95db7c97-a598-4913-a25e-ce5e302cd931 46e9a8bd-8da3-402f-82ac-e727237af2e3 95acc0cd-42e8-4bc9-8957-9e61287c96e5 Yes Participant information sheet 47626 2-WP1-Healthy-Homes-PIS_-V2.0_12052025.pdf e0ab1229-5bc3-402d-b9aa-1ae96d9cfa70 true application/pdf 150326 62955e3bad6f622f7408bf3506be1a05 Dagmar Waiblinger Public Scientific Principal investigator

Bradford Institute for Health Research, Bradford Royal Infirmary Temple Bank House, Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 1274383317 Dagmar.Waiblinger@bthft.nhs.uk Public Tiffany Yang https://orcid.org/0000-0003-4549-7850 Public Scientific Principal investigator

Bradford Institute for Health Bradford Royal Infirmary

Bradford United Kingdom BD9 6RJ - Tiffany.Yang@bthft.nhs.uk Public Ella Foggitt Public

Bradford Institute for Health Bradford Royal Infirmary

Bradford United Kingdom BD9 6RJ - Ella.Foggitt@bthft.nhs.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) 18306736 true INCLUDE Study - Digital exclusion amongst older people INCLUDE This study aims to: 1. Develop an inclusive way of identifying older people who are digitally excluded 2. Explore older people’s views of the internet and what might help them get online 3. Adapt available digital support so it addresses a wide range of needs 4. Test this new approach with a group of older people Background and study aims Older people are more likely to be ‘digitally excluded’. This refers to them not using the internet, so missing out on things that could be helpful to their well-being and health (e.g. making appointments, banking, connecting with family). Support and training is available to increase digital inclusion but there is no process in place to identify everyone needing help. Support tends to be offered when people come into contact with health, social care or community services, rather than through actively identifying people who are digitally excluded. This means that some older people who might benefit from support are not offered it, and we don’t know what support is best for them. This study aims to: • Develop an inclusive way of identifying older people who are digitally excluded • Explore older people’s views of the internet and what might help them get online • Adapt available digital support so it addresses a wide range of needs • Test this new approach with a group of older people Who can participate? Everyone aged 65+ years on 2-3 GP registers What does the study involve? We will send a survey to ask about their internet use. Using their responses we will develop a model that predicts who is more likely to not use the internet. We will talk to older people about their internet use (interviews). We will also talk to voluntary and community organisations that currently provide digital help and support to find out what they do. In workshops with older people and service providers (in a process called co-production) we will explore the needs of those who don’t use the internet. We will review and adapt existing digital support services to make them more accessible to and appropriate for people who are digitally excluded. We will test the adapted service with a group of older people to find out whether it is acceptable. What are the possible benefits and risks of participating? There are no direct benefits from taking part in the research. However, we hope participants enjoy taking part and value contributing to providing better services for older people in the future. Researchers will aim to sign-post people to appropriate services or information should problems be identified during researcher conversations. This sign-posting may support participants to access services or information that supports some aspect of their daily living. We will be asking participants to take part in an interview or a workshop with a researcher. Whilst we do not foresee any risks to this - we will be talking about digital engagement rather than any particularly sensitive topics - people may become anxious or tired during the interview, or discussions may be upsetting if people have experienced frustrations due to difficulties with the internet. Researchers will be vigilant for distress or fatigue, and will offer to stop the interview / discussion where this is the case. We will at all times be respectful of and sensitive to people's needs. Where is the study run from? Bradford Teaching Hospitals NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? November 2023 to August 2026 Who is funding the study? The Dunhill Medical Trust (UK) Who is the main contact? Dr Liz Graham, liz.graham@bthft.nhs.uk 1. The interviews in workstream 2 will explore: 1.1. extent of digital use (e.g. internet and device use); 1.2. what internet/devices are used for (e.g. finances, socialising); 1.3. whether technology helps or hinders management of health and social aspects of life; 1.4. extent to which they feel included/excluded and the associated impacts; 1.5. financial concerns; 1.6. privacy and security concerns; 1.7. digital needs; 1.8. how interventions can better address their needs and skills; 1.9. factors that influence digital behaviours (framed around the COM-B model) Thematic analysis will be used. 2. In Workstream 5, feasibility testing the invervention, baseline and follow-up measures regarding their internet use and a measure of their satisfaction with the intervention will be used. But until we have completed workstream 4, we are not able to define the intervention, and therefore are not able to specify in detail what data will be collected to describe it, and which measures will be most appropriate to monitor its acceptability and feasibility. There are no secondary outcome measures Ethics approval required Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

NHSBT Newcastle Blood Donor Centre, Holland Drive

Newcastle upon Tyne United Kingdom NE2 4NQ 23/YH/0234 10.1186/ISRCTN18306736 332940 CPMS: 58769, SDAF2302\15 332940 58769 SDAF2302\15 Interventional non-randomized feasibility study Interventional Non randomised study Other 2026-08-31T00:00:00.000Z United Kingdom England Bradford Royal Infirmary

Duckworth Lane

Bradford England BD9 6RJ RXF26@2.16.840.1.113883.2.1.3.2.4.18.48 Patient 1. For the survey work (workstreams 1 and 5A), we will include all older people registered at participating GP practices who are aged 65 years and over. For all later workstreams we will also include those aged 65 years and over. Additional inclusion criteria for workstreams 2 (interviews) and 4 (workshops) are: 2. Consented to further researcher contact upon completion of the workstream 1 survey. Additional inclusion criteria for workstream 5B (feasibility study) are: 3. Have never used the internet, or not used it within the last 3 months; and 4. Consented to further researcher contact upon completion of either the workstream 1 or workstream 5A surveys. Senior 65 Years 120 Years All 3990 3990 For the survey work (workstream 1 and 5A), we will exclude: 1. Those who have opted out of data sharing for research purposes, and 2. Those receiving palliative / end of life care For the interviews (workstream 2) and workshops (workstream 4), we will exclude: 3. Those who lack capacity to contribute to the interviews, even with the help of a supporter 4. Those with no consultee available or willing to support involvement where a potential participant lacks capacity to consent. 5. For workstream 4 (workshops) we will also exclude those who took part in workstream 2 interviews. For workstream 5B (feasibility study) we will exclude those who: 6. Lack capacity to engage with the intervention or provide data; or 7. Took part in earlier workstreams. 2024-01-01T00:00:00.000Z 2026-03-31T00:00:00.000Z Digital use in older people Other Workstream 1 - Survey (Months 1-6) A survey will be sent by participating GP practices (using text message and DocMail) to all those on their registers aged 65+ who are eligible to receive the survey. Recipients of the survey will be asked to complete it and send it back (in a pre-paid envelope) to the research team. It will take about 10-15 minutes of their time, and this is the only task we will ask them to do. There will be an opt-out period, after which time, a researcher based at the GP practice will telephone them to see if they would be willing to complete the survey over the phone. We will also explore other ways to administer the survey to maximise engagement - for example, researchers attending GP practices for drop-in sessions, researchers visiting community or faith groups. Surveys will be anonymous, but participants will have the option to provide their contact details if they would like to be entered into a prize draw (a thank you for taking part), hear about the study findings, or be contacted about future parts of this research project. Workstream 2 - Interviews (Months 5-11) Approximately 20 participants who agreed to further contact when they returned their workstream 1 surveys will be invited to take part in interviews. We will sample participants based on characteristics that have been identified in the literature as influencing digital exclusion e.g. age, gender, living status, deprivation, ethnicity; as well as a range of digital use. A researcher will telephone people to invite them to participate. Where the telephone conversation identifies concerns with capacity, the researcher will, sensitively, ask to speak to someone else who might support the person’s involvement, if available, and if feasible. Where a Consultee can be identified, they will be invited to provide agreement to the person's participation, as well as potentially support the person during the interview. Consent or agreement will be obtained before interviews take place. Interviews are expected to last for around 1 hour, and will happen on one occasion. They will be audio recorded with the participants' permission. Participants will be given the choice of location for the interview - they will probably be at their home, but alternative community venues will be identified if preferable. Workstream 3 - service mapping (Months 5-10) A literature review will identify existing evidence for digital support services for older people. Researchers will work with collaborating community partners (Age UK Leeds, Carers' Resource) and others who provide digital inclusion services to identify components of existing service provision. Each service will articulate the target population, format, content and purpose of their current offer. This information will be recorded and mapped by the research team, and cross checked with the providers to ensure accuracy and understanding. (TO NOTE: We have produced a short information sheet for service providers to explain what we would like them to do, but we do not consider them research participants as they are staff whose involvement is limited to them providing information about their professional activities. We will not be asking them for any personal information.) Workstream 4 - Workshops (Months 10-21) Approximately 6 older people (who have agreed to further contact after completing their survey) and 4 service providers will be invited to take part in workshops to identify key components of an intervention (or interventions) that would address digital exclusion. As for workstream 2, we will not exclude people lacking capacity if they have an appropriate consultee who can provide agreement and support for their participation. The exact location for workshops will be decided upon once participants have been recruited; taking into account their accessibility needs, travel distance and transport requirements. It is possible that meeting room facilities in the Bradford Institute for Health Research (Bradford Royal Infirmary site), or Age-UK Leeds offices might be used for workshops; but there may be other locations (e.g. community group spaces) that would be more convenient. Each workshop will last for around 2 hours, and participants will be asked to attend 4-5 such workshops - alternate months for around 7-8 months involvement in total. Workshops will be audio recorded and notes taken. We will use pictorial representations of concepts and media clips to illustrate points for discussion. Other approaches to maximise workshop inclusion and engagement will be agreed in consultation with our PPIE group and wider PPI engagement. We will ask for and act on participants’ feedback between workshops to ensure the presentation style and content are tailored to their needs and preferences; and they are able to actively contribute to the process. At the end of workstream 4 an intervention will have been developed (months 17-21) that can be tested in workstream 5B. Workstream 5A - Testing the identification model (Months 22-27) Methods described for Workstream 1 will be used to distribute the survey from 1-2 GP practices. We require a minimum sample of 100 responses from those who are digitally excluded, so expect to need to distribute at least 2,500 surveys. The survey will be adapted to include factors identified as predictors for digital exclusion. Again, responses will be anonymous, and the survey should only take 10-15 minutes of people's time. Responses received will be used to test the validity of the model - whether it accurately predicts who is digitally excluded. Workstream 5B - Feasibility testing the new intervention (Months 22-32) We will undertake a mixed-methods single-arm feasibility study. A non-randomised design with quantitative and qualitative outcomes is appropriate during the early stages of intervention development, where key questions regarding intervention acceptability and feasibility need to be explored. We will invite 30 older people to take part, contacting those who indicated when they returned the survey that they were willing to be contacted about later stages of the research. It is not yet possible to specify the time commitment or location of the intervention as it has not yet been developed; however, we expect that it will be delivered in a suitable community location (for example, Age-UK premises) but with the option for it to also be delivered remotely (perhaps over the telephone). Similarly, we will be able to collect data from participants in-person (in their home or a community location to suit them) or over the telephone. We expect follow-up (from joining to completing the study) to be around 4 months in duration. A sub-set of people will be invited to an interview to elicit their views on the intervention. All participants will be asked to provide baseline and follow-up measures (e.g. level of internet use). Behavioural The datasets generated during and/or analysed during the current study will be available upon request from Dr Liz Graham (Chief Investigator) liz.graham@bthft.nhs.uk Data arising from the study is owned by the Sponsor organisation - Bradford Teaching Hospitals NHS Foundation Trust. Following publication and dissemination of findings, reasonable requests from external researchers for the anonymised dataset would be considered and agreed by the Project Management Group. Available on request 2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/40973370/ (added 22/09/2025) Protocol

Study website Migrated from study website field

3b1d4902-7226-4c14-9f91-1a3b4b9e5a9d 7984992c-b236-4f1b-85c0-de430a62b21e 67f7edf6-65e0-4b86-913c-c842988e0550 13e64c0a-a408-4da1-bd43-8a12f4712929 Yes Liz Graham https://orcid.org/0000-0003-4276-1257 Public Scientific Principal investigator

Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Royal Infirmary

Bradford United Kingdom BD9 6RJ +44 1274 383443 liz.graham@bthft.nhs.uk Public Caroline Brundle Scientific

Academic Unit for Ageing and Stroke Research Bradford Institute for Health Research Bradford Royal Infirmary Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 (0)1274 383907 caroline.brundle@bthft.nhs.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial Dunhill Medical Trust http://dx.doi.org/10.13039/501100000377 16150114 true A feasibility ‘trial within a cohort study’ (TWiCS) of the 'Incredible Years Toddler' parenting programme: a Born in Bradford’s Better Start cohort sub-study This study aims to establish whether it is feasible to conduct a TWiCs evaluation of a parenting programme for parents of toddlers initially recruited during pregnancy into the Born in Bradford’s Better Start (BiBBS) birth cohort. The specific objectives address key uncertainties and are as follows: 1. To establish whether TWiCS methodology can be implemented to create a control and intervention group, while documenting any incidences of contamination 2. To establish whether satisfactory rates of conversion of randomised participants into intervention participants can be achieved 3. To establish whether satisfactory rates of retention of randomised participants in the intervention can be achieved Background and study aims Born in Bradford’s Better Start (BiBBS) is an interventional birth cohort study that runs in parallel to Better Start Bradford (https://www.betterstartbradford.org.uk/), and is designed to support the evaluation of the effectiveness of early life interventions. The Incredible Years programme (IY) is offered via Better Start Bradford to parents of 1–3-year-olds. BiBBS provides an opportunity to test a Trial Within a Cohort Study (TwiCS) evaluation of IY, where a randomised trial is nested within an observational cohort. Individuals are randomly selected to be offered an intervention and their outcomes are compared to those not selected. The staged information and consent process is person-centred and aims to replicate real-world practice where only those who have access to the intervention being trialled are given information about the intervention. The TwiCS design has shown enormous potential for the conduct of pragmatic trials in other settings but has not yet been applied to an birth cohort to test the effectiveness of a parenting intervention. A feasibility study is necessary due to key uncertainties about the evaluation design. First, the BiBBS cohort is managed by the BiBBS team within the Bradford Institute for Health Research, and they need to obtain consent from parents for a referral to IY-T because IY-T is delivered by an external organisation. This introduces an ‘extra step’ which has not yet been tested in this cohort nor with this intervention, as the BiBBS team does not usually offer intervention referrals, and IY-T usually receive their referrals from their work with the local community. Second, due to the timing of recruitment and the timing of the intervention (where participants are eligible when they have a child aged 12-36 months old), participants will be contacted between 12-36 months after they have enrolled in the BiBBS cohort. This introduces uncertainty about the rate of intervention take-up since most participants will only have heard from the BiBBS project via annual birthday cards/newsletters. Third, contamination (where participants who are allocated to the control group receive the intervention) may occur in this study since IY-T will still receive their usual referrals during the implementation of the TWiCS, however, the level at which this may occur has not yet been measured and remains unknown. Finally, previous studies of parenting programmes have suffered from poor take up and attendance of the intervention, particularly for parents in disadvantaged areas and parents with a higher level of need. This study therefore needs to test the rates of participation and completion of the intervention to inform the feasibility of a larger evaluation, particularly in a disadvantaged setting. This is a feasibility study testing the application of a TWiCS design for offering the IY intervention through the BiBBS cohort. The specific objectives of this feasibility study are: 1. To establish whether TWiCS methodology can be implemented to create a control and intervention group, while documenting any incidences of contamination 2. To establish whether satisfactory rates of conversion of randomised participants into intervention participants can be achieved 3. To establish whether satisfactory rates of retention of randomised participants in the intervention can be achieved Who can participate? Parents of children aged between 12 and 36 months, who are enrolled in the BiBBS cohort. What does the study involve? The researchers will conduct a small-scale feasibility TwiCS to pilot study procedures. This involves identifying an eligible population within BiBBS, randomly selecting and contacting participants to be offered IY, seeking consent to pass contact details onto IY, and monitoring the take-up and engagement of IY. A control population will also be randomly allocated within BiBBS, but no data will be collected from this group of participants. What are the possible benefits and risks of participating? There are no anticipated additional risks or benefits as all processes are a part of standard midwifery care and all data collection has been undertaken as a part of the existing BiB/BiBBS studies. BiBBS participants consented to be randomly allocated to interventions when they enrolled in the cohort. All study staff are trained in Good Clinical Practice and provide opportunities for signposting to relevant services. The IY team will not alter their delivery in any way. Where is the study run from? Better Start Bradford, Better Start Bradford Innovation Hub (UK) When is the study starting and how long is it expected to run for? October 2022 to December 2023 Who is funding the study? 1. The National Lottery Community Fund (UK) 2. National Institute for Health and Care Research (UK) Who is the main contact? Kate E Mooney, kate.mooney@york.ac.uk   The primary outcomes are feasibility outcome targets which will all be measured after recruitment and the intervention have completed. Please note that an ‘enrollee’ is referred and seen face to face in at least one pre-course contact, a ‘participant’ is someone who attends at least 1 week of the groups, and a ‘completer’ is someone that attends at least 8 of the 13 group-based sessions. A RAG rating/traffic light system has been applied to support the feasibility assessment of each objective: to be rated as green (achieved), amber (partly achieved) and red (not achieved). For an objective to be achieved and rated green, it must reach the percentage level specified above (e.g. 70% for contactable women, 50% for converting randomised participants into referrals). The levels at which we reach amber are equal to the green target, minus 20%. This is with the exception of the rate for contamination (outcome 2), where the rates are set on achieving less than 1% contamination. The outcomes are: 1. Feasibility of randomisation pathways (intervention): Successfully contact 70% of participants who were randomised to the intervention 2. Describe any incidences of contamination: Describe any incidences of contamination between the control and intervention allocations, and successfully create intervention and control participants with minimal contamination (<1% crossover across both groups) 3. Retention to intervention (referral consent): Convert 50% of contactable parents into referrals into Incredible Years 4. Retention to intervention (enrolees): Convert at least 50% of the participants who accept the randomised referral into enrollees in Incredible Years 5. Retention to intervention (participants): Convert at least 90% of the participants who enrol in Incredible Years into participants 6. Retention to intervention (completers): Convert at least 60% of the participants who enrol in Incredible Years into completers in Incredible Years All outcomes will be recorded up until the end of December 2023 There are no secondary outcome measures Old ethics approval format The protocol for BiBBS recruitment and collection of routine outcome data was approved by Bradford Leeds NHS Research Ethics Committee (15/YH/0455). The protocol for the current sub-study has been submitted to Bradford Leeds NHS Research Ethics Committee as an amendment to the existing BiBBS protocol. 10.1186/ISRCTN16150114 01 01 Randomized controlled trial Interventional Randomised controlled trial Other 2023-12-31T00:00:00.000Z United Kingdom England Better Start Bradford

Bradford United Kingdom BD5 9NP Healthy volunteer Pregnant mothers are eligible for recruitment to BiBBS if they are living in the BSB area and are registered to give birth at Bradford Teaching Hospital NHS Foundation Trust (BTHFT) (see Dickerson et al., 2016 for further details). For this feasibility TWiCs of IY-T, caregivers will be eligible if they: 1. Provided consent to BiBBS cohort study and agreed to be contacted for future research 2. Have not withdrawn consent to the BiBBS cohort at the time of randomisation 3. Are still living in the BSB area at the time of randomisation 4. Have one or more BIBBS child(ren) aged between 12 and 36 months at the time of randomisation 5. NHS tracing confirms that their child is still living with them, and is alive 6. Have not already received IY-T in the BSB area for any of their children Adult All 240 37 Not currently enrolled in the BiBBS cohort study 2023-06-01T00:00:00.000Z 2023-09-30T00:00:00.000Z Prevention of parental distress resulting in child conduct and behavioural disorder Mental and Behavioural Disorders This study will assess the feasibility of a Trial Within a Cohort Study (TWiCS) evaluation of the Incredible Years Toddler (IY-T) programme using BiBBS cohort participants. Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention (n = 120) or control group (n = 120), using blocked randomisation with stratification by child age (1 year or 2 years at the time of randomisation) and ethnicity (White British, South Asian, or other). The six allocation sequences (one for each stratum) will be generated using Stata/SE v17.0 (for Windows 64-bit x86-64) or later, using the user-written Stata command ralloc. Within Incredible Years Toddler (IY-T), parents learn how to help their toddlers feel loved and secure, encourage social and emotional development, and establish strategies for developing routines, handling separation, and managing misbehaviour (The Incredible Years, 2013). Parents/carers receive three promotional contacts prior to the beginning of the group via assertive outreach, consisting of telephone contact and at least one home visit. The initial telephone contact introduces the parents to the project and Group Facilitators and aims to build the participants' confidence in attending. The home visits are intended to create a sense of rapport between the family and Group Facilitators and alleviate any barriers that families might have in accessing the group such as crèche, language difficulties or concerns about what the group might involve. For more detail on the content and delivery of the IY-T intervention, please see the online information and materials here: https://incredibleyears.com/programs/. The IY-T theory of change and logic model developed by Barnardo’s states that IY-T will result in improvements in child social and emotional development over the medium and long term. This is thought to translate into children entering school with improved language and communication skills. Following this, children would have better literacy and language throughout school, and better achievement on leaving primary school. This logic model was developed the reflex the local BSB implementation. The intervention will be delivered in a combination of face-to-face and virtual formats (dependent on lockdown rules in place at the time of the study and participant needs). The total duration of the intervention is 13 weeks. The duration of follow-up in this study is until the end of the intervention period, so is 13 weeks post intervention enrolment. Behavioural Researchers are encouraged to make use of the BiB data, which are available through a system of managed open access. Before contacting the researchers, please read the Guidance for Collaborators (https://borninbradford.nhs.uk/research/guidance-for-collaborators/). The BiB executive review proposals on a monthly basis and will endeavour to respond to requests as soon as possible. Find out about the different datasets in the Data Dictionary (https://borninbradford.github.io/datadict/) or contact a member of the BiB team (borninbradford@bthft.nhs.uk). Once you have formulated your request please complete the ‘Expression of Interest’ form available here (https://borninbradford.nhs.uk/wp-content/uploads/BiB_EoI_v3.1_10.05.21.doc) and send it to borninbradford@bthft.nhs.uk. If the request is approved you will be asked to sign a Data Sharing Contract (https://borninbradford.nhs.uk/wp-content/uploads/BIHR-Data-Sharing-Contract.docx) and a Data Sharing Agreement (https://borninbradford.nhs.uk/wp-content/uploads/BIHR-Data-Sharing-Agreement.docx), and if the request involves biological samples you will need to complete a material transfer agreement (https://borninbradford.nhs.uk/wp-content/uploads/BiB-Material-Transfer-Agreement-v4-0.docx). Born in Bradford (BiB) is a longitudinal research project. The aim of BiB is to work out why some people have good health or well-being, while others have difficulties. To do this, BiB collects information from participants about all aspects of their lives at different ages using surveys, research clinics and other assessments. BiB also gathers information about families from other sources, such as health records, or environmental records. BiB processes the data to make sure it is accurate, well organised, and to make it so that no person can be identified from the data. BiB then shares this processed data with scientists conducting research with potential public benefit. These scientists can be based anywhere in the world. The data that is available to be shared can be seen here: https://borninbradford.github.io/datadict/bibbs/ Stored in non-publicly available repository 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38291514/ (added 31/01/2024) Protocol

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f3fae7f8-d309-44ab-839f-6d421fed56ad d7754fb8-7988-4827-83cb-e93f8406be3d 09951efc-3e03-4150-b882-a4fcf3d8fa00 3867a81c-3d5e-4222-bdc7-399f14124dda 498e7d05-a86a-4fbf-b03d-5753d14c1624 5120437a-6230-433d-abab-ce03697582b1 Yes Kate Mooney https://orcid.org/0000-0003-4231-1643 Public

Department of Health Sciences Seebohm Rowntree Building University of York

York United Kingdom YO10 5DD +44 (0)1904 321312 kate.mooney@york.ac.uk Public Kate Mooney Scientific

Department of Health Sciences Seebohm Rowntree Building University of York

York United Kingdom YO10 5DD +44 (0)1904 321312 kate.mooney@york.ac.uk Public Sarah Blower https://orcid.org/0000-0002-9168-9995 Principal investigator

Department of Health Sciences Seebohm Rowntree Building University of York

York United Kingdom YO10 5DD +44 (0)1904 321312 sarah.blower@york.ac.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial National Lottery Community Fund (previously the Big Lottery Fund; Ref 10094849) http://dx.doi.org/10.13039/501100013529 National Institute for Health and Care Research (NIHR): Applied Research Collaboration (YHARC) http://dx.doi.org/10.13039/501100000272 31836167 true Effectiveness of a midwife-led continuity of carer model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot and process and economic evaluations. A midwife-led continuity of carer model (MCC) improves birth outcomes and reduces the prevalence of poor maternal mental health in women from ethnically diverse and deprived backgrounds, compared to standard midwifery care. Background and study aims Midwife-led continuity of carer (MCC) is a model of maternity care in which women receive the majority of their care from a named midwife. Features of this model of care include a reduced caseload for midwives, longer appointment times and flexibility in how care is provided. The named midwife is supported by other members of a small team, with the aim of ensuring that flexible working including out of hours cover for labour and birth is safe and sustainable for midwives. There is strong evidence that the MCC model improves birth outcomes. However, we do not know if this model has the same impact on birth outcomes for women from ethnic minority backgrounds or who live in deprived areas. Research has not looked at other impacts of this MCC model, such as on the mental health of women. In Bradford, the MCC model of care has been implemented in inner-city areas where a large number of pregnancies are to ethnic minority women, and those living in deprived areas. There are more women than there are spaces for women to receive MCC care, so women are selected by chance (randomised) at the time that they are referred into midwifery care to either receive the MCC model or standard maternity care. Many women in these areas are taking part in existing Born in Bradford studies which link together participants’ routinely collected health information from midwifery and other services. This study aims to explore whether women who receive the MCC model have better birth and mental health outcomes than women who receive standard midwifery care. All women in the study live in ethnically diverse and deprived areas. The study will also use qualitative methods to understand midwives perspectives on the key components for implementing and delivering the MCC model, and explore whether women’s experiences of birth vary depending on whether they had their MCC midwife with them or not. Additionally, the study will conduct an economic evaluation to identify the cost effectiveness of the MCC model to compare the costs relative to SC. Who can participate? Pregnant women referred for maternity care at BTHFT between the 1st April 2022 and the 31st March 2024, who were randomised to receive their care from the MCC community midwifery teams or a standard care midwifery team, and who are a part of existing Born in Bradford research studies. To be selected for an interview with researchers, women must have received the MCC care, had a live birth and have given consent to take part (by completing a ‘consent to contact’ form and giving verbal consent at the start of their interview). What does the study involve? For women who have been randomised to MCC or standard care, and who are a part of the BiB studies, the research team will compare information about their birth and mental health outcomes. The research team will also speak to a small number of women who received MCC care to understand more about their experiences, and how these differed based on the level of continuity received at birth. Midwives will complete diaries to provide insight about the key components to successfully deliver MCC care. What are the possible benefits and risks to participants? There are no anticipated additional risks or benefits for this trial as all processes are a part of routine midwifery care, and all data collection has been undertaken as a part of existing BiB studies. For the qualitative interviews, women will be asked to relive their experience of birth, and talk about their wellbeing, which may bring up difficult memories or emotions. MCC midwives and team leaders will be asked to keep reflective diaries, which may be challenging if describing a distressing situation. Where is the study run from? Born in Bradford, Bradford Teaching Hospitals NHS Foundation Trust (BTFHT) (UK) When is the study starting and how long is it expected to run for? April 2021 to September 2025 Who funds the study? The National Lottery Community Fund (Better Start Bradford), Reducing Inequalities in City Bradford District and Craven CCGs, NIHR ARC Yorkshire & Humber (UK) Who is the main contact? 1. Rachael Baum (rachael.baum@bthft.nhs.uk) 2. Josie Dickerson (Josie.Dickerson@bthft.nhs.uk) Current primary outcome measures as of 28/02/2023: 1. Spontaneous vaginal delivery indicated at birth, measured using data obtained via the linked routine health (maternity) record for cohort participants 2. Maternal depression measured using the PHQ-8 assessment tool at 6-10 weeks postnatal Previous primary outcome measures: Internal Pilot: 1. Number of women randomised relative to the total number eligible using data obtained from the maternity service and cumulative trial monitoring data at 3 months 2. Allocation ratio measured using cumulative trial monitoring data at 3 months Effectiveness Evaluation: Primary outcome measures: Parent 1. Spontaneous vaginal delivery indicated at birth, measured using data obtained via the linked routine health (maternity) record for cohort participants 2. Mental ill health measured using the PHQ-8 and GAD-7 assessment tools at 6-10 weeks postnatal Process Evaluation: Midwifery teams: 1. Number of reflective diaries completed by MCC midwives (maximum 2 per individual) and team leaders (maximum 4 per individual) using research team study records on 31/03/2024 2. Detail of the challenges and barriers staff within the MCC midwifery team faced when providing this model of care, obtained qualitatively (i.e., free text) through the study-specific reflective diaries completed either twice (for midwives) or 4 times (for team leaders) per year Women: 1. Number of interviews completed by women who received MCC care during (at least) the antenatal and postnatal periods assessed using research team study records on 31/03/2024 2. Pregnancy, birth and postnatal experiences of women who received MCC care assessed using qualitative interviews. A study-specific topic guide will explore the thoughts and experiences of women who received MCC care at different stages of their pregnancy journey; these will take place between 4-20 weeks post-birth Economic Evaluation: 1. Health-related quality of life at 1 year postnatal, measured using data obtained from the linked routine health record for cohort participants. Information captured at any point between referral to maternity and up to one year following birth will be included in analyses 2. Health-related resource use at 1 year postnatal, measured using data obtained from the linked routine health record for cohort participants. Information captured at any point between referral to maternity and up to one year following birth will be included in analyses Current secondary outcome measures as of 28/02/2023: Effectiveness Evaluation Secondary outcome measures: Parent 1. Emergency caesarean birth indicated at birth, using data obtained via the linked routine health (maternity) record for cohort participants 2. Breastfeeding initiation (first feed) indicated within the first 24 hours after birth, using early postnatal data obtained via the linked routine health (maternity) record for cohort participants 3. Identification of poor perinatal mental health while receiving midwifery care by a member of the maternity service. This will be measured using data obtained from the linked routine health (maternity) record for cohort participants; information captured at any point between referral and discharge will be included in analyses. Coded data will be examined for indication of poor mental health, with reference to predetermined code lists. 4. Experience of poor mental health in the first 12 months following birth, identified via routine data linkage of the health visiting and GP records of cohort participants. Coded data will be examined for indication of poor mental health, with reference to predetermined code lists. 5. Parent-child relationship assessed using the Mothers Object Relations Scale (MORS) at 6-10 weeks postnatal 6. Maternal anxiety measured using the GAD-7 assessment tools at 6-10 weeks postnatal Secondary outcome measure: Child 1. Low birth weight (<2500 g; any gestational age) indicated at birth using data obtained via the linked routine health (maternity) record for cohort participants Previous secondary outcome measures: Effectiveness Evaluation Secondary outcome measures: Parent 1. Emergency caesarean birth indicated at birth, using data obtained via the linked routine health (maternity) record for cohort participants 2. Breastfeeding initiation (first feed) indicated within the first 24 hours after birth, using early postnatal data obtained via the linked routine health (maternity) record for cohort participants 3. Identification of poor perinatal mental health while receiving midwifery care by a member of the maternity service. This will be measured using data obtained from the linked routine health (maternity) record for cohort participants; information captured at any point between referral and discharge will be included in analyses. Coded data will be examined for indication of poor mental health, with reference to predetermined code lists. 4. Experience of poor mental health in the first 12 months following birth, identified via routine data linkage of the health visiting and GP records of cohort participants. Coded data will be examined for indication of poor mental health, with reference to predetermined code lists. 5. Parent-child relationship assessed using the Mothers Object Relations Scale (MORS) at 6-10 weeks postnatal Secondary outcome measure: Child 1. Low birth weight (<2500 g; any gestational age) indicated at birth using data obtained via the linked routine health (maternity) record for cohort participants Old ethics approval format 1. Approved 07/12/2021, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 2071048083; bradfordleeds.rec@hra.nhs.uk), BiBBS, ref: 15/YH/0455 2. Approved 04/10/2018, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 2071048083; bradfordleeds.rec@hra.nhs.uk), BiB4All, ref: 17/YH/0202 3. Approved 07/06/2023, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 2071048083; bradfordleeds.rec@hra.nhs.uk), qualitative process evaluation, ref: 22/YH/0072 10.1186/ISRCTN31836167 309549 CPMS: 52348 309549 52348 Single-centre open labelled individual prospective randomized controlled trial with an internal pilot phase and qualitative process and economic evaluations Interventional Randomised controlled trial Prevention 2025-09-30T00:00:00.000Z United Kingdom England Bradford Teaching Hospitals NHS Foundation Trust

Bradford Royal Infirmary Duckworth Lane

Bradford United Kingdom BD9 6RJ RAE@2.16.840.1.113883.2.1.3.2.4.18.48 Patient Current inclusion criteria as of 28/02/2023: Effectiveness Evaluation 1. Have been randomised to receive intervention or control care 2. Have consented to take part in Born in Bradford (BiB) cohort studies: BiBBS (Born in Bradford Better Start) study or BiB4All (Born in Bradford for all) cohort study Process Evaluation 1. Have received the MCC model of care 2. Had a live birth a minimum of 4 weeks and a maximum of 20 weeks before the time of recruitment 3. Have completed a ‘consent to contact’ form (to confirm the research team can get in touch with them) 4. Have given informed consent to participate in a qualitative interview 5. Speak a language accessible to the research team Previous inclusion criteria: Randomisation for MCC care 1. Be referred or make a self-referral to the BTHFT Women’s and Newborn Unit for pregnancy care, between the 1st April 2022 and the 31st March 2024. 2. Reside in the BSB area or be registered with a general medical practice (GP) associated with the RIC programme, and within the geographical remit of the standard care teams forming the eligible population for the trial. And: 3. Be less than 29 weeks gestation at the time of referral for maternity care. 4. Have no requirement for a referral to a specialist midwifery team or consultant care. Effectiveness Evaluation 1. Have been randomised to receive intervention or control care 2. Have consented to take part in Born in Bradford (BiB) cohort studies: BiBBS (Born in Bradford Better Start) study or BiB4All (Born in Bradford for all) cohort study Process Evaluation 1. Been randomised to receive MCC model of care 2. Had a live birth a minimum of 4 weeks and a maximum of 20 weeks before the time of recruitment 3. Have completed a ‘consent to contact’ form (to confirm the research team can get in touch with them) 4. Have given informed consent to participate in a qualitative interview Adult Female 734 663 Effectiveness evaluation 1. Have pregnancy loss or termination (<24 weeks gestation) 2. Have not registered their pregnancy <29 weeks gestation 3. Move outside of the geographical remit of the care teams following randomisation 4. Withdraw consent for data linkage via the BiB4All/BiBBS cohorts before the end of the evaluation period Process Evaluation 1. Have pregnancy loss 2. Have a stillbirth/infant death 3. Their child is still receiving care/treatment in hospital 2022-04-05T00:00:00.000Z 2024-02-29T00:00:00.000Z Prevention of negative birth outcomes and poor perinatal mental health in vulnerable pregnant women. Pregnancy and Childbirth The MCC model of care provides women with a full continuity of carer service throughout the antenatal, intrapartum and postnatal periods, delivered by a named midwife and support team. Compared to standard care, MCC midwives are given smaller caseloads, can offer longer appointment times and prioritise discussion surrounding public health messages. Point-of-care randomisation with minimisation and multiple stratification variables will be employed. Women will be randomised by administration staff in the MCC teams. Random allocation to either the control (standard care) or intervention arm (MCC) will be completed before patients are contacted by the care provider. Eligible women will be randomised at the point of referral to the maternity service to receive either the MCC (midwife-led continuity of care) intervention or to receive standard community midwifery care (SC). Those who are randomised to receive MCC will experience a relationship-based, continuity of carer approach where a single midwife plans and provides care for a woman throughout the antenatal, intrapartum and postnatal stages. MCC midwives are responsible for smaller caseloads (maximum of 35 women per full-time equivalent midwife) or more (depending on staffing pressures in SC) and therefore, can offer a personalised care service, with longer appointment times and tailored discussion surrounding public health messages. Women receiving MCC care will receive this type of care if they are less than 29 weeks gestation at the time of referral for maternity care, up until postnatal discharge from the service (the timing of which may be different for each woman), when their MCC midwife transfers their care to their health visitor (via their GP). SC aims to provide team-based antenatal care though women may be seen by midwives from other community teams if necessary, and intrapartum care is provided by hospital midwives only. Given the larger caseload size in the SC arm, the duration and location of appointments are restricted, and women are discharged 2 weeks postnatal unless they are in need of specialist care. Behavioural Researchers are encouraged to make use of the BiB data, which are available through a system of managed open access. Before you contact us, please make sure you have read our Guidance for Collaborators (https://borninbradford.nhs.uk/research/guidance-for-collaborators/). The BiB executive review proposals on a monthly basis and we will endeavour to respond to your request as soon as possible. You can find out about the different datasets in our Data Dictionary (https://borninbradford.github.io/datadict/). If you are unsure if we have the data that you need please contact a member of the BiB team (borninbradford@bthft.nhs.uk). Once you have formulated your request please complete the ‘Expression of Interest’ form available here (https://borninbradford.nhs.uk/wp-content/uploads/BiB_EoI_v3.1_10.05.21.doc) and send to borninbradford@bthft.nhs.uk. If your request is approved we will ask you to sign a Data Sharing Contract (https://borninbradford.nhs.uk/wp-content/uploads/BIHR-Data-Sharing-Contract.docx) and a Data Sharing Agreement (https://borninbradford.nhs.uk/wp-content/uploads/BIHR-Data-Sharing-Agreement.docx), and if your request involves biological samples we will ask you to complete a material transfer agreement (https://borninbradford.nhs.uk/wp-content/uploads/BiB-Material-Transfer-Agreement-v4-0.docx). IPD sharing summary Born in Bradford (BiB) is a longitudinal research project. The aim of BiB is to work out why some people have good health or well-being, while others have difficulties. To do this, BiB collects information from participants about all aspects of their lives at different ages using surveys, research clinics and other assessments. BiB also gathers information about families from other sources, such as health records, or environmental records. BiB processes the data to make sure it is accurate, well organised, and to make it so that no person can be identified from the data. BiB then shares this processed data with scientists conducting research with potential public benefit. These scientists can be based anywhere in the world. The data that is available to be shared can be seen here: https://borninbradford.github.io/datadict/bibbs/ Stored in publicly available repository 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37996235/ (added 24/11/2023) Protocol

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OSF Registry

Participant information sheet Migrated from patient info sheet field

Study website Migrated from study website field

0c355ea5-f244-4db4-9fbd-c68608a95afb bef0a0d8-b68e-4238-910c-94533195a713 72e0450b-f03e-4ccc-af36-c9c843344408 7ba1daff-06f6-4175-8e3f-29ae9433c1c0 0352c8f5-b466-4550-a408-1b65b65aacc9 3327d3bd-8005-466e-952e-ac03509b2e7c Yes Josie Dickerson https://orcid.org/0000-0003-0121-3406 Scientific

Bradford Institute for Health Research Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 1274 383916 Josie.Dickerson@bthft.nhs.uk Public Rachael Baum https://orcid.org/0000-0002-3015-7768 Scientific

Bradford Institute for Health Research Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 1274 364474 rachael.baum@bthft.nhs.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial National Lottery Community Fund (Better Start Bradford) http://dx.doi.org/10.13039/501100013529 Reducing Inequalities in Communities (Bradford District and Craven CCG) NIHR ARC Yorkshire and Humber 46750688 true Phase 1 trial of COVID-19 airborne transmission prevention technologies Class-ACT Air Cleaning Technologies reduce the transmission of COVID-19 in school pupils and staff Background and study aims The COVID-19 pandemic has wreaked havoc upon the education of a whole generation of school children. It is estimated that school children have lost at least a half of an academic year due to the pandemic. Education analysts have assessed the numbers of children achieving or exceeding the expected level for their age in reading, writing and maths compared with pre-pandemic scores. Whilst rates of transmission of COVID-19 have dropped during the summer months there is a high risk that if no action is taken to mitigate airborne transmission, the risk of infection is likely to increase again in the autumn and winter seasons. The result being further school closures. The aim of this study is to conduct an early phase trial of two air cleaning technologies with a focus on feasibility and practical implementation. The air cleaning technologies have the potential to mitigate the aerosol transmission of viral particles - including the SARS-CoV-2 virus - within schools. This study seeks to explore the practicalities and possible benefits of fitting schools with these technologies. Who can participate? The study will be conducted within 30 primary schools in Bradford, UK. What does the study involve? The study will have three arms: a control arm and two intervention arms; one with installation of portable high efficiency particulate air (HEPA) filter units, and the other with installation of germicidal ultraviolet (GUV) devices. What are the possible benefits and risks of participating? There is a potential benefit for children and staff within the schools with air cleaning technology (i.e. reduced infection from air bourne illness) but this remains to be determined. There are little to no risks associated with the research (the worse case scenario is a data breach that would reveal data – schools absences – that are already collected within the Local Authority). Where is the study run from? The study is run from the Centre for Applied Education Research which is based at the Bradford Teaching Hospitals NHS Foundation Trust, UK. When is the study starting and how long is it expected to run for? January 2021 to September 2022 Who is funding the study? The study is funded by the Department for Health and Social Care (UK) Who is the main contact? Prof. Mark Mon-Williams, M.Mon-Williams@leeds.ac.uk School absences for COVID-19 measured using anonymised data contained in schools information management systems and relayed to Local Authority at weekly intervals 1. CO2, humidity, PM2.5 & PM10 levels in classrooms measured through air monitoring devices at 60 second intervals and relayed via API. 2. Power usage levels for HEPA devices measured through power consumption monitoring devices at 60 second intervals and relayed via API. 3. Primary and secondary Care level data will be collect via Connected Yorkshire data set at weekly intervals. The Connected Yorkshire programme links disparate routine electronic data in an anonymised database across primary care, secondary care, community care and social care for over 700,000 individuals at Bradford Teaching Hospitals NHS Foundation Trust. Old ethics approval format Approved 13/12/2021, School of Psychology Research Ethics Committee (School of Psychology, University of Leeds, LS2 9JT, UK; +44 113 343 5724; G.S.Finlayson@leeds.ac.uk), ref: PSYC-414 10.1186/ISRCTN46750688 BTHFT 2662 BTHFT 2662 Multi centre randomized controlled trial of environmental interventions Interventional Randomised controlled trial Other 2022-09-30T00:00:00.000Z United Kingdom England Centre for Applied Education Research

Temple Bank House Bradford Royal Infirmary Duckworth Lane

Bradford United Kingdom BD9 6RJ Other 1. Primary school 2. 5 - 11 year-old students 3. Naturally ventilated buildings Mixed All 30 32 1. Mechanically ventilated schools 2. Secondary schools 3. Further education establishments 2021-06-01T00:00:00.000Z 2021-08-31T00:00:00.000Z Prevention of COVID-19 transmission in school pupils and staff Infections and Infestations This study will be an early phase trial of two air cleaning technologies with a focus on feasibility and practical implementation. This study seeks to explore the practicalities and possible benefits of fitting schools with these technologies in order to mitigate the aerosol transmission of viral particles -including the SARS-CoV-2 virus. The study will be conducted within 30 primary schools in Bradford, UK. The study will have three arms: a control arm and two intervention arms; one with the installation of portable high-efficiency particulate air (HEPA) filter units, and the other with the installation of germicidal ultraviolet (GUV) devices. Participating schools will be randomly allocated to each arm. Randomisation process: Schools names were drawn from a bag Intervention & follow up length: 1st August 2021 – 1st August 2022 Device Not Applicable portable high-efficiency particulate air (HEPA) filter units, germicidal ultraviolet (GUV) devices The datasets generated during and/or analysed during the current study will be stored in the non-publically available repository within the Bradford Institute of Health Research. The datasets generated during and/or analysed during the current study are/will be available upon request. (M.Mon-Williams@leeds.ac.uk) Stored in non-publicly available repository Available on request Protocol

Study website Migrated from study website field

0f48dfad-b959-4d86-95c2-1219d491a51f 2f6bf584-e26a-4f79-8c09-d1912988a86e e69e3779-93f4-4816-98ae-6acbb0559bd4 Yes Participant information sheet 41288 PIS.pdf c1656438-cd43-4af0-b1a3-e207a1bb0d44 true application/pdf 574621 98e5a5dc9c85fe0f4d7757fe7cc92720 Protocol file 41288 Protocol.pdf 27153004-c8ba-4dd4-99f3-ad49e2e8d20f true application/pdf 977068 3918d0fb94ac8203a3b259d4fabfd453 Mark Mon-Williams https://orcid.org/0000-0001-7595-8545 Principal investigator

Centre for Apllied Education Research Wolfson Centre for Applied Helath Research Bradford Royal Infirmary Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 1274 36 6878 M.Mon-Williams@leeds.ac.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial UK Health Security Agency 17472338 true Advancing Tools for Human Early Life-course Exposome Research and Translation (ATHLETE) ATHLETE The main study hypothesis is that the exposome (all non-genetic exposures) can influence health. The researchers are seeking to characterize and examine relationships between the exposome and adolescent cardio-metabolic, respiratory, and mental health. Background and study aims Major environmental hazards such as ambient air pollution, environmental tobacco smoke, water and food contaminants, noise, pesticides and ultraviolet light may lead to long-term health effects with large social and economic costs. As part of the previous European Commission Exposome Programme HELIX project, researchers used new tools and methods to characterise the totality of environmental exposures – known as the ‘exposome’ – to a wide range of hazards including both external exposures to the physical and chemical environment as well as the internal molecular signatures associated with these environmental exposures and investigated their impact on child health outcomes. This study aims to continue this research by exploring the impacts of exposure on adolescent health and co-producing interventions to reduce exposure. This is one of six birth cohort studies internationally taking part in this research. Who can participate? In WP1, the original HELIX cohort participants (n = 231 aged 6-7 years) who are now in adolescence (aged 13-14 years) will be followed up. In WP7, children aged 9-11 who attend two identified Bradford primary schools will be invited to participate. What does the study involve? In WP1, the researchers will assess a variety of measures including clinical examinations (including body composition, blood pressure, lung health, and neurodevelopment), biological samples (including blood, urine, and stool), sensor data (capturing movement and environmental exposures), as well as questionnaires capturing lifestyle behaviours and health. In WP7, the researchers will work with two Bradford schools and 50 schoolchildren aged 10-11 to co-produce interventions to reduce exposure to pollution. School children will wear mobile sensors for up to 7 days to monitor where and when exposure to urban air pollutants occurs. The researchers will also conduct ‘walking interviews’ with 15 parents and their children to explore their experience of pollution on the school commute. The data collected will be used to co-produce interventions with pupils, teachers, local decision-makers, and researchers to reduce children’s exposure to pollution. What are the possible benefits and risks of participating? Participants will contribute to the understanding of exposure risks in early life health. Participants in WP7 will increase their understanding of urban exposures and participate in co-producing interventions to reduce child exposure to air pollutants. Potential risks include time commitments and the potential inconvenience of carrying measurement devices and blood sampling from those who consent. Where is the study run from? Bradford Institute for Health Research (UK) When is the study starting and how long is it expected to run for? January 2020 to April 2027 Who is funding the study? European Union Horizon 2020 Who is the main contact? Prof. Rosie McEachan rosie.mceachan@bthft.nhs.uk There is no singular outcome as WP1 will measure a host of personal and environmental exposures from personal monitoring, sensors, biosamples, and questionnaires. Similarly, there will be sensor data, questionnaires, and interviews for WP7 which will be used to describe environmental exposure. Measures occurring at the clinical examination visit: 1. Anthropometry for height and weight is measured using SECA scales and the Leister Height Measure d=1mm; waist circumference is measured using a flexible tape measure. These are measured at one point in time and can be conducted up to 7 days before baseline (the start of the monitoring period) or 7 days after blood collection. 2. Bioimpedance is measured using the Bodystat 1500NDD device at one point in time and can be conducted up to 7 days before baseline (the start of the monitoring period) or 7 days after blood collection. 3. Blood pressure is measured using the OMRON electronic 705-CP11 device at one point in time and can be conducted up to 7 days before baseline (the start of the monitoring period) or 7 days after blood collection. 4. Spirometry is measured using the EasyOne spirometry device at one point in time and can be conducted up to 7 days before baseline (the start of the monitoring period) or 7 days after blood collection. 5. Neurodevelopment is measured using the N-back test (working memory), Roulettes task (risk-taking preferences), and Raven Standard Progressive Matrices (non-verbal general intelligence). These are computerized tasks that are conducted at one point in time and can be conducted up to 7 days before baseline (the start of the monitoring period) or 7 days after blood collection. Biological samples: 1. Environmental exposures measured from hair (50 mg or ~1 cm² of scalp area) collected close to the scalp using scissors at one point in time and can be conducted at any time relative to the baseline visit. 2. Phthalates measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 3. Phenols measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 4. Organophosphate pesticides measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 5. Other pesticides (metabolites of pyrethroids, 2,4-dichlorophenoxyacid, boscalid, and imazalil) measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 6. Cotinine measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 7. Glycol ethers measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 8. Polycyclic aromatic hydrocarbon measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 9. Creatinine measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 10. Exogenous metabolomics measured from urine samples (collected using the Vitrex Vacusense 112510 kit) collected twice a day for 6 days from baseline. 11. The microbiome measured from stool samples (collected using Zymo Research 1101 collection tubes) collected once on day 7 from baseline. 12. Endogenous metabolomics measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 13. Glucose measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 14. Total and high-density lipoprotein (HDL) cholesterol measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 15. Triglycerides measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 16. Phospholipids measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 17. Glucose measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 18. Alanine transaminase (ALT) measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 19. Aspartate aminotransferase (AST) measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 20. Gamma-glutamyl transferase (GGT) measured from fasting blood (using 6 ml silica (clot activator) vacutainer) collected once in a 3-day window starting on day 8 from baseline. 21. Exogenous metabolomics measured from fasting blood (using 5 ml silicone coated glass vacutainer 367614) collected once in a 3-day window starting on day 8 from baseline. 22. Metals and elements from fasting blood (using 6 ml K2EDTA (trace element determination) 368381) collected once in a 3-day window starting on day 8 from baseline. 23. Telomere length from fasting blood (using 6 ml K2EDTA (trace element determination) 368381) collected once in a 3-day window starting on day 8 from baseline. 24. Per- and polyfluoroalkyl substances (PFAS) from fasting blood (using 6 mL K2EDTA (trace element determination) 368381) collected once in a 3-day window starting on day 8 from baseline. 25. Endogenous metabolomics from fasting blood (using 6 mL K2EDTA (trace element determination) 368381) collected once in a 3-day window starting on day 8 from baseline. 26. Transcriptomics from fasting blood (using PAXGene 762125) collected once in a 3-day window starting on day 8 from baseline. Sensor data: 1. Personal monitoring of sleep patterns and physical activity is collected sing the GENEActive devices for a period of 7 consecutive days from baseline. 2. Personal exposure data including to air and light pollution, sleep, physical activity, and location will be collected using the EXPOApp3 smartphone app for a period of 7 consecutive days from baseline. 3. Personal monitoring of physical activity is collected using the ActiGraph GT3X-BT for 7 consecutive days from baseline. 4. Personal exposure to NO2 is collected using Palmes passive diffusion tubes for 7 consecutive days from baseline. 5. Geocoding of home and school addresses, green spaces, and usual commuting routes is performed using the QGIS software version 3.12.3 “Bucureşti”. This is done once and can be conducted up to 7 days before baseline (the start of the monitoring period) or 7 days after blood collection. 6. Socioeconomic status is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 7. Ethnicity of the adolescent’s parents is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 8. Perceived stress of the adolescent’s parent is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 9. Adolescent’s diet is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 10. Food security is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 11. Adolescent’s physical activity is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 12. Adolescent’s asthma and allergies is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 13. COVID-19 symptoms and contact is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 14. Adolescent’s medication is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 15. Adolescent’s sleeping patterns is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 16. Cooking and heating use is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 17. Parental medical history is collected using a parental questionnaire completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 18. Address history is collected using a parental questionnaire completed flexibly at baseline, clinical visit, over the telephone, or at home during the 7 monitoring days following the baseline visit. 19. Adolescent’s schooling is collected using a parental questionnaire completed flexibly at baseline, clinical visit, over the telephone, or at home during the 7 monitoring days following the baseline visit. 20. The home environment is collected using a parental questionnaire completed flexibly at baseline, clinical visit, over the telephone, or at home during the 7 monitoring days following the baseline visit. 21. Adolescent’s behavioural and emotional problems are collected using the Child Behaviour Checklist completed flexibly at baseline, clinical visit, or at home during the 7 monitoring days following the baseline visit. 22. Adolescent’s dietary intake, eating habits, and food environment is collected using a Food Frequency Questionnaire (FFQ) and an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 23. Adolescent’s physical activity is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 24. Adolescent’s alcohol use is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 25. Adolescent’s mental health is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 26. Adolescent’s tobacco exposure is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 27. Adolescent’s noise exposure is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 28. Adolescent’s outdoor environment is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 29. Adolescent’s sleeping patterns are collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 30. Adolescent’s light exposure is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. 31. Adolescent’s pubertal development is collected using an adolescent questionnaire completed at the clinical visit, usually 7 days before blood collection, or baseline. Other measures collected as part of the co-produced intervention study: 1. Air pollution around schools is collected using static air quality sensors for a period of up to 18 months. 2. Personal air pollution is collected using portable air quality sensors for 1 week at baseline, 1 week pre-intervention, 1 week during the intervention period, and 1 week 6 months post-intervention. 3. Nitrogen dioxide exposure collected using NO₂ diffusion tubes for 1 week at baseline, 1 week pre-intervention, 1 week during the intervention period, and 1 week 6 months post-intervention. 4. Personal exposure data, including to air and light pollution, sleep, physical activity, and location will be collected using the EXPOApp3 smartphone app collected for 1 week at baseline, 1 week pre-intervention, 1 week during the intervention period, and 1 week 6 months post-intervention. 5. Mode of travel between home and school collected using travel diaries at 1 week at baseline, 1 week pre-intervention, 1 week during the intervention period, and 1 week 6 months post-intervention. 6. School travel modes and preferences, play and physical activity, physical and mental health collected using a survey at 1 week at baseline, 1 week pre-intervention, 1 week during the intervention period, and 1 week 6 months post-intervention. 7. Participant observations of route home from school collected using the PicVoice app at baseline. 8. Participant discussion group of PicVoice app outputs conducted using the Photovoice method within 3 months of baseline. 9. Participant experiences of taking part and perceived impact and sustainability of the intervention collected using focus groups at 6 months post-intervention. 10. Teacher interviews on experiences of taking part and perceived impact and sustainability of the intervention collected using interviews at 6 months post-intervention. There are no secondary outcome measures Old ethics approval format Approved 17/12/2020, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048083; bradfordleeds.rec@hra.nhs.uk), REC ref: 20/YH/0315 10.1186/ISRCTN17472338 289958 CPMS: 47578 289958 47578 Non-randomized; Both; Design type: Prevention, Psychological & Behavioural, Physical, Cohort study Interventional Non randomised study Other 2027-04-30T00:00:00.000Z United Kingdom England Bradford Institute for Health Research

Bradford Teaching Hospitals NHS Foundation Trust Bradford Royal Infirmary Duckworth Lane

Bradford England BD9 6RJ true WP 1: All participants (parents and children) that have consented and contributed to data collection in HELIX (n=231 families) WP7: 1. Parent with child in Year 5 or 6 (9-11 years old) attending participating school 2. Child able to follow air quality data collection protocol with support from teacher and parent 3. Parent able to give informed consent and child able to give verbal assent to the researcher Mixed All 296 230 WP1: 1. Any participant that has consented and contributed to data collection in HELIX, but has withdrawn from the Born in Bradford cohort since or wishes to withdraw when approached for this follow-up 2. Any participant that has participated in HELIX and declines consent for Athlete WP7: 1. Parent does not give informed consent 2. Parent does not feel that the child will be able to operate the sensor or adhere to the data collection process 2021-04-15T00:00:00.000Z 2026-03-31T00:00:00.000Z Environmental hazards such as ambient air pollution, environmental tobacco smoke, water and food contaminants, noise, pesticides and ultraviolet light Other WP1 (follow up with participants): All participants approached are part of BiB and have taken part previously in HELIX. They have given consent to be contacted in the future. Participants will be contacted by phone and by invitation letter. If interested in taking part, the researchers will have a detailed discussion with the parent and adolescent to ensure it is clear what is involved and any questions can be answered. In view of COVID-19 this cannot happen at a home visit which would have been preferable. Given the situation, the researchers will do this over the phone and via Zoom call or similar (depending on what the participant prefers). The parent and the adolescent will complete a consent form. The adolescent will receive different devices measuring exposure over a 7-day period. These may be dropped off at the house. - A smartphone with the ExpoApp3 installed (placed in a pouch to measure mobility) - Carry a GENEActiv (on the wrist to measure sleeping patterns) - Carry an Actigraph (attached to the belt to measure physical activity) - Carry a NO₂ diffusion tube, placed on the outside of their backpack, to measure personal exposure to NO₂ During the 7-day period the researchers will also ask the adolescent to collect: - Two urine samples every day: the first morning and the last of the day - A faeces sample to study the adolescent’s gut microbiota The adolescent will complete a daily sleep and physical activity diary and a short questionnaire. Taking part involves ideally two visits to the study centre (due to COVID-19 all face to face data collection will be carried out at the Clinical Research Facility). One visit is for the assessment of the adolescent: measurements (height and weight, BP, bioimpedance, spirometry (depending on the COVID-19 situation), cognitive assessments and collection of a lock of hair (small enough not to affect the adolescent’s appearance). Another visit will be after the 7-day measuring period for blood sampling. This will be a morning appointment to allow for fasting samples. Also, all devices will be returned. The researchers will provide transport to the Clinical Research Facility. They will also offer a reimbursement of £50 to show their appreciation for their participation. WP7: The researchers will be co-producing acceptable and feasible interventions to reduce the urban exposome amongst primary school-age children. There are three key parts to data collection: a) static monitoring in schools, b) personal urban exposure monitoring with primary school-age children to quantify their exposure to the urban exposome with N=50 school children recruited from two schools, and c) walk-along interviews with 15 parent and children dyads to explore their perceptions of the urban exposome on the route from school, and their perceived barriers and enablers to reducing the harmful urban exposome. The researchers will obtain informed consent from headteachers and parents, and assent from children. These data will be used to co-produce interventions to reduce the urban exposome with children, parents, teachers and local ‘healthy place decision makers’ (e.g. from local authorities). Mixed Contact should be made with Dan Mason (dan.mason@bthft.nhs.uk) for details on obtaining any of the data collected as part of WP1. Researchers will be required to submit an expression of interest and, if approved, sign a Collaboration Agreement. For WP7 the data are not expected to be made available because the data generated will be used to co-produce an intervention which will then be implemented and evaluated. Results for WP7 will be published. Added 30/12/2021: Quantitative data collected as part of WP1 will be available as part of the Born in Bradford repository. Data will be cleaned and linked to existing resources prior to availability. All data collected have been granted ethical approval and participant consent for its continued availability. Data requests are made to the BiB executive using the form available from the study website: http://www.borninbradford.nhs.uk (please click on ‘Science and Research’ to access the form). Guidance for researchers and collaborators, the study protocol and the data collection schedule are all available via the website. All requests are carefully considered and accepted where possible. Available on request Published as a supplement to the results publication Protocol

Added from spreadsheet

Study website Migrated from study website field

4ae8576d-92a9-4905-9520-ae99d43bd160 c9b661b8-5c71-43b6-afca-114f61a9cb23 d0dfeeae-4188-4feb-b7df-3bc0bf5265ef Yes Protocol file ISRCTN17472338_PROTOCOL_V3_23Aug21.pdf 0ad309ce-78e0-48d3-9fa6-a3d964488a28 true application/pdf 1645927 cd6f5ed804f6c55d854ee24a43ab8593 Rosie McEachan https://orcid.org/0000-0003-1302-6675 Scientific

Bradford Teaching Hospitals NHS Foundation Trust Bradford Institute for Health Research Bradford Royal Infirmary Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 (0)1274 38 3173 Rosie.mceachan@bthft.nhs.uk Public Bradford Royal Infirmary Hospital/treatment centre https://ror.org/01ck0pr88 Non-commercial European Commission; Grant Codes: H2020-SC1-BHC-2018-2020 http://dx.doi.org/10.13039/501100000780 67530835 true Evaluating the life-course health impact of a city-wide system approach to improve air quality in Bradford, UK: A quasi-experimental study with implementation and process evaluation BiB Breathes Aims and research questions: We aim to assess the impact of the Bradford Clean Air Plan (B-CAP, including a charging Clean Air Zone) on attitudinal, behavioural, air pollution and health outcomes, and its cost-effectiveness, using a multi-outcome, multi-sector approach. We also aim to explore the factors influencing any impact (or lack of) and explore unintended or unanticipated outcomes. The impact of the B-CAP on health inequalities amongst different socio-economic and ethnic groups will be assessed across all outcomes. Research Questions: 1. What are the key barriers and enablers to implementation of the B-CAP (including acceptability), and are there unintended consequences of the B-CAP for different stakeholder groups (e.g., increased health and economic inequalities)? 2. Does the B-CAP affect travel choice behaviour and attitudes amongst Bradford residents at 12 months post implementation? 3. Does the B-CAP reduce exposure to pollution amongst primary school age children up to 12 months post implementation? 4. What is the impact of the B-CAP 3 years post-implementation on: 4.1. Respiratory health (primary outcome, as assessed by weekly counts of respiratory disease related emergency hospital or General Practice [GP] attendance) of children (aged <18), adults (aged 18-64) and older adults (aged 65+) 4.2. Cardiovascular health (as assessed by weekly counts of cardiovascular disease related emergency hospital/GP attendance) of adults and older adults 4.3. Birth outcomes such as low birth weight and preterm birth (assessed by monthly counts) 5. How does the B-CAP impact on health inequalities up to three years post implementation? 6. What is the value for money of the B-CAP three years post-implementation and longer term? Background and study aims The UK has high levels of air pollution, which costs the NHS and society around £20 billion a year. Poor air quality is a major cause of early death and illness. It has been linked to lung and heart disease in children and adults and low birth weight. During periods of poor air quality, health gets worse, leading to more hospital admissions and deaths. Children and the elderly are particularly affected by pollution. Poorer areas of the country have worse air quality and this increases inequalities in health. Thirty three local councils with high pollution levels have to put in place air quality plans which include Clean Air Zones. Bradford will introduce a Clean Air Zone in 2021 in order to reduce pollution using policies such as charging people for driving polluting vehicles. However, there is little evidence whether these policies improve air quality and health and what effect they might have on health inequalities. The aim of the study is to evaluate the impact of a Clean Air Zone on air quality, health and health inequalities in the city of Bradford. Who can participate? People living within Bradford District. What does the study involve? We will explore changes in air quality in the city using regularly collected data that is already available on air pollution and will also collect additional data from 12 schools throughout the city. In addition, 240 children in these schools will help us collect data by using mobile air sensors for three months before the Clean Air Zone is put in place and for three months in the year after. The impact on lung, heart health and birth weight will be measured by comparing the health of over 500,000 Bradford residents in the three years before and three years after the Clean Air Zone is in place. The research will examine whether the impact is different for people from more deprived areas or different ethnic groups. This will use detailed information collected on 13,500 children who are part of the Born in Bradford study. We will look at whether the policy changes the way people choose to travel by conducting a survey with 4000 families. We will also conduct group discussions and interviews with key groups of people including businesses, transport companies, families, and pedestrians. These discussions will explore what may have helped or hindered the success of the policy and any unexpected effects. We will also explore if the Clean Air Zone is good value for money, e.g. do any improvements in health justify the costs. What are the possible benefits and risks of participating? This study will use anonymised routinely collected health data from residents living in Bradford collected before and after the B-CAP is implemented. As such there are no direct risks of taking part. To explore the impact of the B-CAP on air quality Primary school children will also be asked to carry portable air quality sensors in the year prior, and year following B-CAP implementation. We do not forsee any risks with taking part in this part of the study. In return we will work with participating schools to develop curriculum based air quality research materials which we hope will inspire learning in science related subjects. Patient/Public Involvement 100 community members and two schools have been involved in developing our proposal and thinking about how to test if the policy will work and what effect it will have on the residents of Bradford. We have also worked closely with Bradford council and the UK Government department responsible for air quality nationally (DEFRA). Community, school and local authority representatives are part of our study team. They will be actively involved in the development and management of our research. DISSEMINATION: We will share our findings widely using a range of approaches depending on the audience. Researchers, policy and decision makers will receive academic papers, policy briefings, and be invited to events. We will communicate our research with communities through a series of short 'in a nutshell' reports publicised widely through social media channels, local media links, and engagement events. We will also develop materials for schools based on our findings to inspire and inform the next generation of researchers. Where is the study run from? Bradford Institute for Health Research (UK) When is the study starting and how long is it expected to run for? July 2020 to June 2026 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Prof. Rosie McEachan (scientific), rosie.mceachan@bthft.nhs.uk Emily Nix (public), emily.nix@bthft.nhs.uk Respiratory health of Bradford residents (as assessed by weekly counts of respiratory disease related emergency hospital or General Practice [GP] attendance) of children (aged <18), adults (aged 18-64) and older adults (aged 65+) at three years post implementation of the B-CAP 1. Cardiovascular health of Bradford residents (as assessed by weekly counts of cardiovascular disease related emergency hospital/GP attendance) of adults (aged 18-64) and older adults (aged 65+) assessed three years post implementation 2. Birth outcomes of babies born within Bradford such as low birth weight and preterm birth (assessed by monthly counts) assessed three years post implementation 3. Air quality (Nitrogen Dioxide, Particulate matter) collected using routine and bespoke monitoring assessed one year post implementation. From the process and implementation evaluation: 4. Intervention fidelity, adaptations, barriers and enablers to implementation, acceptability, adverse/unintended consequences, travel mode behaviour and attitudes assessed one year post implementation From the economic evaluation: 5. Key economic outcomes include healthcare resource use and costs, quality adjusted life years, distributional effects assessed 3 years post implementation Old ethics approval format Approved 30/06/2020, Bradford Leeds (Yorkshire and the Humber) NHS Research Ethics committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8018; bradfordleeds.rec@hra.nhs.uk), ref: 281405 10.1186/ISRCTN67530835 281405 281405 Quasi-experimental interrupted time series design Other Not applicable Prevention 2026-06-30T00:00:00.000Z United Kingdom England Bradford Institute for Health Research

Bradford Teaching Hospitals NHS Foundation Trust Duckworth Lane

Bradford England BD9 6RJ All Living within Bradford District All All 500000 0 Participants who move out of Bradford district during duration of the study. 2021-03-15T00:00:00.000Z 2025-01-20T00:00:00.000Z Respiratory health, cardiovascular health, birth outcomes Respiratory The Bradford Clean Air Plan In order to address illegal levels of pollution within the City, Bradford Council have been directed by the UK Government to develop and implement the Bradford 'Clean Air Plan' (B-CAP). With a planned implementation date in late 2021, the plan includes a range of activities designed to reduce concentrations of nitrogen dioxide within the city to legal levels as soon as possible. The B-CAP will include a charging clean air zone (CAZ) class ‘C’ (targeting non-compliant taxis, buses, heavy goods vehicles [HGVs], and light goods vehicles [LGVs]) Daily charges will be £12.50 for taxis, £9 for LGVs and £50 for HGVs. Exemptions will be provided for local small/medium enterprises (SMEs), schools and charities. The Bradford ambition is for the CAZ to be supported by a range of other activities/components including: Electric bus routes in key parts of the city with road space allocation to prioritise buses and reduce journey times; grants to retrofit polluting buses to CAZ standards; introduction of clean air standards for all Taxis registered in Bradford so only compliant vehicles can operate; grants and incentive schemes to encourage i) taxi drivers to upgrade to minimum CAZ standards (hackney carriages), petrol/hybrid (private hire vehicles), or electric (both), ii) HGV, LGV, Coach and minibus owners to upgrade to minimum CAZ standard; new park and ride facilities for up to 1000 vehicles /day; installation of alternative energy centre providing cost effective green refuelling/recharging facilities; travel planning with businesses to promote car sharing, active travel and public transport use amongst employees); and an engagement programme to encourage a reduction in polluting heating sources with the CAZ boundary. We will explore changes in air quality in the city using regularly collected data that is already available on air pollution and will also collect additional data from 12 schools throughout the city. In addition, 240 children in these schools will help us collect data by using mobile air sensors for three months before the Clean Air Zone is put in place and for three months in the year after. The impact on lung, heart health and birth weight will be measured by comparing the health of over 500,000 Bradford residents in the three years before and three years after the Clean Air Zone is in place. The research will examine whether the impact is different for people from more deprived areas or different ethnic groups. This will use detailed information collected on 13,500 children who are part of the Born in Bradford study. We will look at whether the policy changes the way people choose to travel by conducting a survey with 4,000 families. We will also conduct group discussions and interviews with key groups of people including businesses, transport companies, families, and pedestrians. These discussions will explore what may have helped or hindered the success of the policy and any unexpected effects. We will also explore if the Clean Air Zone is good value for money, e.g. do any improvements in health justify the costs. Other Data sharing statement to be made available at a later date 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37390911/ (added 14/08/2023) 2023 Results article in https://doi.org/10.1016/j.jth.2023.101654 (added 14/08/2023) 2025 Results article in https://pubmed.ncbi.nlm.nih.gov/39884541/ Health and nitrogen dioxide (added 19/02/2025) 2024 Results article in https://doi.org/10.3310/nihropenres.13730.1 Process and implementation evaluation (added 19/02/2025) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36464683/ (added 05/12/2022) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38899121/ Qualitative study (added 30/10/2024) 2025 Other publications in https://doi.org/10.1016/j.ubtr.2025.100016 A qualitative study relating to the process and implementation evaluation work-package (added 09/01/2026) Results

Health and nitrogen dioxide

Process and implementation evaluation

Qualitative study

A qualitative study relating to the process and implementation evaluation work-package

912a4d24-6e24-4ff7-961a-16da01012ca2 df18fd5f-55be-4406-907f-c30328ad066a f4539ff1-fd33-4a6f-9e63-7c0c3b69bd54 94ff7772-eeb2-4a17-88d9-36a57f52995f No Rosemary McEachan https://orcid.org/0000-0003-1302-6675 Scientific

Bradford Institute for Health Research Bradford Teaching Hospitals NHS Foundation Trust Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 (0)1247364474 rosie.mceachan@bthft.nhs.uk Public Emily Nix Public

Bradford Institute for Health Research Bradford Teaching Hospitals NHS Foundation Trust Duckworth Lane

Bradford United Kingdom BD9 6RJ +44 (0)1274364474 emily.nix@bthft.nhs.uk Public Bradford Teaching Hospitals NHS Foundation Trust Hospital/treatment centre https://ror.org/05gekvn04 Non-commercial Public Health Research Programme http://dx.doi.org/10.13039/501100001921