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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 329222 |
| Protocol serial number | Nil known |
| Sponsor | University of Stirling |
| Funder | Chief Scientist Office, Scottish Government Health and Social Care Directorate |
- Submission date
- 22/05/2025
- Registration date
- 23/05/2025
- Last edited
- 22/08/2025
- Recruitment status
- No longer 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
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomized controlled trial |
| Secondary study design | Pilot randomized controlled trial |
| 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(s) |
1. Recruitment, randomisation and retention: |
| Key secondary outcome measure(s) |
1. Number of cigarettes smoked per day (in general and in the home) (measured by baseline and follow up questionnaires) |
| 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 | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
Hamilton
ML3 0TA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Protocol article | 21/08/2025 | 22/08/2025 | Yes | No | |
| Participant information sheet | version 1.3 | 11/12/2024 | 23/05/2025 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 47385 Participant Information Sheet v1.3.pdf
- Participant information sheet
Editorial Notes
22/08/2025: Publication reference added.
23/05/2025: Trial's existence confirmed by West of Scotland Research Ethics Service 3.
