Assessing the feasibility of using nicotine replacement therapy (NRT) to enable disadvantaged parents to create a smoke-free home
| ISRCTN | ISRCTN79307718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79307718 |
| IRAS number | 329222 |
- Submission date
- 22/05/2025
- Registration date
- 23/05/2025
- Last edited
- 23/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The harmful health effects of children’s exposure to second-hand smoke are well established. Most second-hand smoke exposure now occurs in the home, in low-income households. This is because smoking rates are higher in more disadvantaged groups, who may find it harder to create a smoke-free home because of challenges including limited access to private outdoor space or being a sole parent.
Who can participate?
Parents, and carers and relatives who are at least 18 years old, smoke in the home, and care for one or more children aged 5 or over in the home, at least 1 day per week, will be eligible to participate. Multiple family members can participate in the study. The study is based in Lanarkshire in Scotland, and those who participate should live here.
What does the study involve?
Previous research suggests that using nicotine replacement therapy (NRT) in the home could help to reduce the amount of smoking indoors. We want to build on this work and test in the future if using NRT works for people who smoke and their families as a way to reduce children’s exposure to second-hand smoke. First, we need to conduct a smaller version of this study to test whether we can deliver it as planned. Some people who smoke will get free NRT posted to their home alongside telephone support for 12 weeks to reduce children’s exposure to second-hand smoke. We will compare this with other people who smoke who receive current Scottish Government advice on reducing children’s exposure to second-hand smoke in the home. We will check whether enough people who smoke want to be involved in the study, how acceptable (or not) the study is with people who smoke and look at the potential costs of this approach. If results are promising, we will seek funding for a larger trial to tell us whether using free NRT in the home to reduce children’s exposure to second-hand smoke improves child health outcomes and is effective for the NHS.
Where is the study run from?
The study is led by the University of Stirling, with recruitment led by our study partner NHS Lanarkshire (UK)
When is the study starting and how long is it expected to run for?
The study started in June 2023 and it will run until May 2026.
Who is funding the study?
The Chief Scientist Office, which is part of the Scottish Government Health Directorates (UK)
Who is the main contact?
Dr Rachel O'Donnell, at the Institute for Social Marketing and Health, University of Stirling, Scotland. Email: r.c.odonnell@stir.ac.uk
Contact information
Public, Scientific, Principal Investigator
Institute for Social Marketing and Health, University of Stirling, Pathfoot Building
Stirling
FK94LA
United Kingdom
 ORCID ID |
0000-0003-2713-1847 |
|---|---|
| Phone | +44 7804499922 |
| r.c.odonnell@stir.ac.uk |
Study information
| Study design | Pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Pilot randomized controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | 47385 Participant Information Sheet v1.3.pdf |
| Scientific title | A pilot randomised control trial of an intervention to reduce children’s exposure to second-hand smoke in the home in disadvantaged communities in Scotland |
| Study objectives | Principal Research Question: Is the intervention feasible in terms of participation and retention rates, NRT adherence, and the practicalities of intervention delivery within an established NHS service? |
| Ethics approval(s) |
Approved 15/12/2023, West of Scotland Research Ethics Service 3 (Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 141 314 0212; WoSREC3@ggc.scot.nhs.uk), ref: 23/WS/0153 |
| Health condition(s) or problem(s) studied | Children's exposure to second-hand smoke in the home |
| Intervention | Intervention arm (Group A): Fifty participants are being randomly allocated to Group A. They receive a free, 12-week supply of nicotine replacement therapy posted to home, an information sheet on how to use NRT effectively, plus fortnightly telephone support to aid effective use of NRT for temporary abstinence in the home. Control group (Group B): Fifty participants are being randomly allocated to Group B. Group B participants are signposted to the Scottish Government’s ‘Take it Right Outside’ advice by email. This NHS Inform website provides tailored interactive advice on creating a smoke-free home. On completion of the study at week 12, all participants in the control arm are being offered the NRT information sheet and a 12 week’s supply of free NRT products posted-to-home fortnightly. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Recruitment, randomisation and retention: 1.1. Number of participants screened, eligible and successfully recruited into the study, and the characteristics of non-consenting and ineligible participants (measured using a baseline data collection tool and Excel recruitment tracker) 1.2. Number of participants enrolled in the allocated recruitment time (measured using an Excel recruitment tracker) 1.3. Retention of participants in their trial arms following randomisation, the proportion engaging in 12 week follow ups, and number/reasons for dropping out (measured using an Excel recruitment tracker). 2. Intervention delivery: 2.1. The proportion of participants (a) receiving NRT and demonstrating their adherence to NRT at fortnightly follow ups; and (b) engaging in fortnightly telephone support calls (all monitored by Excel participant tracker). 3. Data collection methods: Proportion of completed baseline and follow up assessments in each arm; Number of participants successfully providing child saliva samples and measuring air quality at baseline and 12 week follow up. |
| Secondary outcome measures | 1. Number of cigarettes smoked per day (in general and in the home) (measured by baseline and follow up questionnaires) 2. Home smoking practices (measured by baseline and follow up questionnaires) 3. Self-reported quit attempts (measured by follow up questionnaire) 4. Nicotine dependence (measured at baseline and 12 week follow up using the Heaviness of Smoking Index). 5. We are also testing the feasibility of participants collecting saliva samples from their youngest child (age 5 or over) for cotinine analysis, and collection of resource use and economic data prior to a future definitive trial. |
| Overall study start date | 01/06/2023 |
| Completion date | 31/05/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Resident |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Parents, and carers and relatives 2. Aged at least 18 years old 3. Smokes in the home 4. Cares for one or more children aged or over in the home, at least 1 day per week, most days. 5. Multiple family members can participate in the study. 6. Individuals who are interested to take part but live with another adult smoker who does not wish to, are able to participate. |
| Key exclusion criteria | 1. Individuals who are not able to understand or speak English as their primary language are excluded given we do not have a budget to recruit, train and pay bilingual staff. 2. Individuals who use Warfarin, Theophylline or Aminophylline, Clozapine, Erlotinib, Olanzapine, Riociguat, Chlorpromazine, Flecainide, Methadone or Warfarin are excluded as NRT use would require GP monitoring. 3. Pregnant and breastfeeding women are excluded from participation as the NRT products offered are only licensed for this group of people who are making a quit attempt. 4. Participants who have a hypersensitivity to nicotine or any components of the nicotine replacement products offered in this study and listed in the product literature are excluded from taking part – we establish this by asking specific questions regarding any previous use of NRT and whether participants have any allergies. |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Hamilton
ML3 0TA
United Kingdom
Sponsor information
University/education
University of Stirling
Stirling
FK9 4LA
Scotland
United Kingdom
| Phone | +44 1786 473171 |
|---|---|
| rachel.beaton@stir.ac.uk | |
| Website | http://www.stir.ac.uk |
"ROR" |
https://ror.org/045wgfr59 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, The Chief Scientist Office, CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Protocol - planned publication in a peer reviewed journal Main findings - planned publication in a peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Rachel O'Donnell - r.c.odonnell@stir.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.3 | 11/12/2024 | 23/05/2025 | No | Yes |
Additional files
Editorial Notes
23/05/2025: Trial's existence confirmed by West of Scotland Research Ethics Service 3.
