Real-world exploration of digital innovation for managing excess weight
| ISRCTN | ISRCTN18398308 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18398308 |
| Integrated Research Application System (IRAS) | 351778 |
| Central Portfolio Management System (CPMS) | 70372 |
| National Institute for Health and Care Research (NIHR) | 208095 |
| Sponsors | Guy's and St Thomas' NHS Foundation Trust, King's College London |
| Funder | National Institute for Health and Care Research |
- Submission date
- 08/12/2025
- Registration date
- 09/01/2026
- Last edited
- 09/01/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity describes a person who is very overweight, with a lot of body fat. Obesity is a common problem in the UK, affecting one in every four adults. It can cause other health problems, including heart disease, diabetes, some cancers, and can affect mental health. The NHS is struggling to care for all the patients who need support, with parts of the country having no services at all, and others having long waiting lists of over a year. Some programmes are not working well for ethnic minority patients. Digital health solutions are a promising way to make sure everyone can get the care they need to reduce their weight and improve health outcomes, but more evidence is needed to prove these solutions work and are fair for all.
This project will help us understand whether digital weight management programmes can be as helpful as the standard care currently offered to people living with obesity or who are overweight. It will explore whether they can help people lose weight, offer cost savings to the National Health Service, improve experiences of care for patients and staff, and help widen access to the benefits of weight management programmes for as many types of patients as possible.
Who can participate?
Adults who have been accepted into the NHS South East London Tier 3 programme and meet the eligibility criteria for the study.
What does the study involve?
Taking part in the study involves participants using an app-based digital weight loss programme called Roczen for 12 months.
What are the possible benefits and risks of participating?
Possible benefits of participating – study participants will receive free, 12-month access to the Roczen weight management programme app. Study participation will help us to understand whether digital weight management programmes are as effective as the standard of care currently offered to people living with obesity. Information collected during this study may, in the future, result in more/better options available to patients needing weight management services such as the Tier 3 service.
Possible risks of participating – No risks are expected from taking part in the study.
Where is the study run from?
1. Guy’s and St Thomas’ NHS Foundation Trust, UK.
2. King's College London, UK.
When is the study starting and how long is it expected to run for?
December 2025 to June 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR), UK.
Who is the main contact?
Dr Andrew Walker, Chief Investigator, Guy’s and St Thomas’ NHS Foundation Trust, andrew.walker8@nhs.net
Contact information
Scientific, Principal investigator, Public
Health Innovation Network South London
Chief Investigator Guy’s and St Thomas’ NHS Foundation Trust
Beckett House, 1 Lambeth Palace Road
London
SE1 7EU
United Kingdom
 ORCID ID |
0000-0003-1128-8954 |
|---|---|
| Phone | +44 020 7848 7295 |
| andrew.walker8@nhs.net |
Scientific, Public
King’s College London
Department of Twin Research
St Thomas’ Hospital Campus, 3rd Floor South Wing Block D, Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Phone | +44 0758 591 6529 |
|---|---|
| emma.duncan@kcl.ac.uk |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Non-randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Real-world Exploration of digital iNnovation managing Excess Weight (RENEW) | |
| Study acronym | RENEW | |
| Study objectives | Primary Objectives: • To investigate clinical- and cost-effectiveness (defined as percentage of weight change and EQ-5D-5L) of Roczen (1-year) versus (vs.) Tier 3 standard care • To investigate post-Tier 3 clinical and cost-effectiveness (defined as percentage of weight change and EQ-5D-5L) of Roczen for 1 year vs. standard care (discharge to GP) Secondary Objectives: • To investigate the feasibility and acceptability (for patients and clinicians) of integrating Roczen as a supportive digital weight-management model of care within existing pathways • To identify predictors of uptake, retention, and success-in-programme, for both Roczen users and standard-care users (including ethnicity and IMD) to inform development of both personalised weight management and more clinically- and cost-effective weight-management pathways | |
| Ethics approval(s) |
Approved 28/10/2025, East of England-Cambridge East Research Ethics Committee (2 Redmond Place, Stratford, London, EC20 1JQ, United Kingdom; +44 020 7104 8096; CambridgeEast.REC@hra.nhs.uk), ref: 25/EE/0191 | |
| Health condition(s) or problem(s) studied | Specialty: General Practice, Primary sub-specialty: General Practice; Health Category: Cancer and neoplasms, Cardiovascular, Metabolic and Endocrine, Oral and Gastrointestinal, Stroke; Disease/Condition: Obesity and other hyperalimentation | |
| Intervention | This study is a real-world evaluation of 2.5 years duration. The study will use a quasi-experimental design, which is more practical in answering our research questions. It will allow us to mimic how the Roczen weight management app will be delivered if used as part of a specialist Tier-3 weight management pathway, thereby making the findings generated from the research more generalisable. This design was also used because of the impracticalities of randomly assigning enough patients to ensure the results are valid in the time given. The study’s main aims are to find out how effective Roczen is in treating patients compared to either standard care (Tier-3 treatment) or post-discharge standard care in reducing weight, and to see how the costs compare. It also wants to see if Roczen can be easily used and accepted by patients and NHS staff as a digital tool to help manage weight within current healthcare systems and to find out what makes people start, stick with, and succeed in the Roczen programme compared to standard care. This will help to improve personalized weight management and make weight-management programs more effective and affordable. There is no random allocation in this study. Main Study - Intervention Arms All eligible patients will be invited to participate in the intervention arm of the study from two groups (Group A & Group B) of GSTT Tier-3 patients who will be identified by the GSTT Tier-3 clinical care team. Group A intervention arm will be patients who are being referred to the Tier-3 weight management service and who have been accepted into the GSTT Tier-3 service and are entering the waitlist. Group B intervention arm will be patients who are completing the GSTT Tier-3 programme and will be discharged back to GP care. The intervention arms from both groups will be recruited at the same time. The study aims to recruit 967 patients to reach 290 participants who complete the 12-month Roczen programme (assuming a 30% retention) in both groups' intervention arm. Participants in the intervention arms of the study will receive 12 months of weight-management service via the Roczen app. Participants will receive the following activities while using Roczen's services: Screening All patients recruited into an intervention arm will be sent a patient information sheet and electronic consent form to review and sign (electronically). Upon the patient's consent to the study, an SMS invitation from Roczen will be sent to the patient so that they can download the Roczen app to their smartphone. Onboarding Once the patient has downloaded the Roczen app, they will have an onboarding appointment with a Roczen clinician via video through the app (timepoint=Month 0). Virtual consultations (Months 1, 2, 3, 6, 8, and 11 timepoints) Virtual check-ins will be video calls via the Roczen app with dieticians or nurse specialists. Clinical messaging support (Months 0-12) Roczen clinicians will send messages to participants via the app weekly in the first month and then once per month until the end of the study (end of Month 12). Participants can also message clinicians at any time in the app if they have a question. Moderated group mentoring (Months 0-12) Mentoring is optional and is available at any time throughout the 12-month programme via the app. This includes monthly video webinars as well as a group messaging channel within the app. The group messaging channel is moderated and facilitated by Roczen staff members who are qualified health coaches. Universal community support (Months 0-12) Universal community support is also available at any time throughout the 12-month programme. It is provided via the group messaging channel in the app and includes educational articles, movement videos, and recipes. Clinical measures Roczen will ask participants to input their weight into the app once per month for the study Roczen will ask participants to input their waist circumference measurement into the app once per month during the study. Roczen will ask participants to input their blood pressure numbers 3 times during the study (at Month 0, Month 6, and Month 12) Questionnaires (Months 0, 6, 12) Participants will be asked to complete some questionnaires about their health at these time points. Any serious adverse events (SAEs) will also be recorded for the intervention arms (Months 0-12) Main Study-Control Arms Group A contemporaneous control arm will include the data from 290 patients who are coming off the GSTT Tier-3 waitlist and starting the Tier-3 service, and who complete 12 months of Tier-3 service. Group B contemporaneous control arm will include 290 patients who are approached to participate in the Group B intervention arm of the study but choose not to and are discharged from Tier-3 service back to the care of their GP. To supplement data for the control arm, we will also include fully anonymised data of 4500 previous Tier-3 service users. Study controls will not be consented to the study. Instead, the NHS National Opt-out will be used. Participants in both the intervention arm and control arm of both groups (Group A and Group B) will have the following data collected at the following timepoints: Month 0 - Demographics, Medical history (obesity-related), Weight, Height, Waist circumference, Blood pressure, Health questionnaires Month 6 - Weight, waist circumference, blood pressure, health questionnaires Month 12 - Weight, waist circumference, blood pressure, health questionnaires Sub-study: All participants - One qualitative interview will be conducted with 84 patients who were invited to participate in the main study to explore how feasible and acceptable Roczen is to patients. In addition, there will also be interviews with 20 staff members from both the Roczen and GSTT Tier 3 clinical care teams. Each interview will last around 60 minutes and will mainly be conducted online using Microsoft Teams. | |
| Intervention type | Mixed | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 1990 |
| Key inclusion criteria | Participants will be included in the Main Study for the following reasons: 1. 18 years of age or older 2. Referred to the South East London Tier 3 weight management pathway by their GP 3. Accepted by the GSTT Tier 3 weight management service Participants will be included in the Sub-study for the following reasons: 1. 18 years of age or older 2. A patient accepted by the GSTT Tier 3 service, invited to Group A or Group B of the Main Study or a staff member involved in commissioning or delivery of South East London’s Tier 3 service or a Roczen service staff member delivering care in the study |
| Key exclusion criteria | Participants will be excluded from the Main Study for the following reasons: 1. Do not have use of a smartphone 2. Do not read, write, or speak English 3. Are unable and/or unwilling to provide informed consent 4. Have a diagnosis of an eating disorder 5. Have had bariatric surgery 6. Currently have deranged thyroid function tests 7. Have type-1 diabetes 8. Are on insulin of sulfonylureas at high risk of hypoglycemia Participants will be excluded from participating in the Sub-study for the following reasons: 1. Are unable or unwilling to provide informed consent 2. Do not read, write, or speak English |
| Date of first enrolment | 30/12/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Westminster Bridge Road
London
SE1 7EH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
08/12/2025: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
