Could giving someone who smokes help to quit through a financial advice service make them more likely to quit than someone who does not get any support?
| ISRCTN | ISRCTN12504090 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12504090 |
| IRAS number | 342278 |
| Secondary identifying numbers | IG138, NIHR158844, CPMS 61737 |
- Submission date
- 07/05/2025
- Registration date
- 27/08/2025
- Last edited
- 27/08/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to find out if helping people who smoke quit through a financial advice service makes them more likely to stop smoking compared to those who don't get any support. People with lower incomes are more likely to smoke and less likely to quit, which can lead to health problems. Brief advice and support to stop smoking can improve their chances of quitting. Providing this help where people seek financial advice might help more people quit smoking.
Who can participate?
People aged 18 years or older who smoke and are seeking financial advice can participate in this study.
What does the study involve?
Participants will be asked if they smoke during routine financial advice appointments. If they do, they will be invited to join the study. Those who agree will be randomly placed into one of two groups. One group will not receive any guidance on quitting smoking. The other group will receive advice on the best ways to quit, be sent a nicotine vape, and get help accessing behavioral support like a smartphone app or counseling. Participants will be contacted 12 weeks and 9 months after receiving financial support to check on changes in their smoking, quality of life, tobacco spending, and financial wellbeing. They will also be interviewed about their experiences in the study.
What are the possible benefits and risks of participating?
Benefits: Participants may get help to address their health behaviour; participation will help the advancement of science, healthcare, financial support and policy; participants will be reimbursed for some of their time.
Risks: we will ask you to commit some of participants’ time to taking part; taking part will involve disclosing some personal information; however, this will be kept confidential, in-line with trial procedures.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
April 2025 to March 2029.
Who is funding the study?
National Institute for Health and Care Research (NIHR) in the UK.
Who is the main contact?
For more information, you can contact the study team at savings@phc.ox.ac.uk
Contact information
Scientific, Principal Investigator
Nuffield Department of Primary Care and Health Services
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0003-2539-9268 |
|---|---|
| Phone | +44 1865 289296 |
| nicola.lindson@phc.ox.ac.uk |
Public
Nuffield Department of Primary Care and Health Services
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| ORCID ID |
0000-0001-9726-8975 |
|---|---|
| Phone | +44 1865 283922 |
| savings@phc.ox.ac.uk |
Study information
| Study design | Two-arm parallel randomized controlled trial with embedded pilot phase economic and process evaluations |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Charity/Voluntary sector, Community, Other |
| Study type | Treatment, Efficacy |
| Participant information sheet | To follow |
| Scientific title | Brief opportunistic smoking cessation advice for financially vulnerable Individuals accessing financial support: a randomised controlled trial |
| Study acronym | SAVINGS |
| Study objectives | Adults receiving financial guidance who smoke tobacco will be more likely to quit smoking if they receive very brief, opportunistic cessation advice embedded within their usual financial support service contacts compared to those receiving usual care. |
| Ethics approval(s) |
Not yet submitted 31/07/2025, The Central University Research Ethics Committee (CUREC), University of Oxford (Research Ethics Manager, Research Services, University of Oxford, Boundary Brook House, Churchill Drive, Headington, Oxford, OX3 7GB, United Kingdom; +44 1865 616577; ethics@medsci.ox.ac.uk), ref: Reference number not provided |
| Health condition(s) or problem(s) studied | Tobacco addiction |
| Intervention | This is a randomised controlled trial to assess the effects of very brief, opportunistic, smoking cessation advice compared to usual care, provided by financial guidance services to adults receiving support for financial difficulties who smoke tobacco. The aim is to recruit 1,538 people (769 in each arm) from financial advice services like food banks, Job Centres, and Citizens Advice across England, Scotland, and Wales. Participants are expected to be involved for about 9 months, with a longer-term follow up of 9 months. Participants will be randomised 1:1 to the intervention or usual care. Randomisation will take place electronically through an online database. The intervention group will receive opportunistic, very brief advice on smoking, including information on the best ways to quit and providing and referring participants to relevant support. A nicotine e-cigarette will be provided alongside information on behavioural support available, including free access to a stop smoking app if preferred. Those in usual care (the control) will receive no further intervention after being asked about their smoking in-line with usual care for this setting in the UK. There will be a qualitative process evaluation. This will involve audio-recorded interviews with about 30 participants and 20 financial services advisors about their experiences with the intervention. There will also be a conversation analysis of about 350 financial advice service sessions to identify if: the intervention is delivered as intended; common pitfalls which may hinder delivery; and how these might be best managed or avoided. There will also be approximately 100 control group consultations for fidelity testing. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Biochemically validated four-week prolonged abstinence from tobacco at 12 weeks post-randomisation. Saliva samples will be tested for cotinine and/or anabasine dependent on the use of non-tobacco nicotine post-quit attempt. 2. Biochemically validated prolonged abstinence from tobacco between the 12-week and 9-month follow-ups. Saliva samples will be tested for cotinine and/or anabasine dependent on the use of non-tobacco nicotine post-quit attempt. 3 . Self-reported 7-day point prevalence tobacco abstinence at 12-weeks and 9-month follow-ups. 4. Serious adverse events (SAEs) at 12-week follow-up. |
| Secondary outcome measures | Estimate the intervention’s cost-effectiveness relative to usual care from the public sector perspective. This will be judged based on 4 outcome measures: 1.1. Financial well-being, measured using the abbreviated Consumer Financial Protection Bureau scale at 12-weeks and 9-month follow-ups. 1.2. Health-related quality of life, measured using the EuroQol EQ-5D-5L at 12-weeks and 9-month follow-ups. 1.3. Incremental cost per QALY gained at 12-weeks and 9-month follow-ups. 1.4. Mental well-being, measured using the Warwick-Edinburgh Mental-Wellbeing Scale at 12-weeks and 9-month follow-ups. Embedded process evaluation investigating factors, e.g., number of quit attempts and intervention acceptability, influencing effects of the intervention. This will be judged based on 10 outcome measures: 2.1. Proportion making at least one quit attempt (defined as 24-hours or more of abstinence) – self reported at 12-weeks and 9-month follow-ups. 2.2. Change in number of self-reported cigarettes smoked per day between baseline and follow-ups at 12-weeks and 9-month follow-ups. 2.3. Proportions of smoke-free households (defined as none of the members of a household currently smoking tobacco), self-reported at 12-weeks and 9-month follow-ups. 2.4. Self-reported change in tobacco expenditure from baseline to follow-ups at 12-weeks and 9-month follow-ups. 2.5. Intervention fidelity at 12-weeks and 9-month follow-ups. 2.6. Intervention acceptability at 12-weeks and 9-month follow-ups. 2.7. Self-reported follow-on smoking cessation behavioural support, e-cigarette and medication use (including length of use) at 12-weeks and 9-month follow-ups. 2.8. Participants’ experiences of the intervention post-baseline (during the follow-up period). 2.9.Service advisors’ experiences of the intervention post-baseline (during the follow-up period). 2.10. If the intervention is delivered as intended (and what may hinder or support this) post-baseline (during the follow-up period). |
| Overall study start date | 01/04/2025 |
| Completion date | 31/03/2029 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1,538 |
| Key inclusion criteria | 1. Able to give informed consent to participate. 2. Adults aged 18 years or over regardless of if they have any medical conditions or if they are pregnant. 3. Currently receiving advice or support for financial difficulties by financial guidance services. 4. Self-reported daily tobacco smoking, regardless of motivation to quit smoking. 5. People who can provide a phone number and/or email address and a postal address to be contacted at, for the purposes of follow-up. |
| Key exclusion criteria | 1. People using only smokeless tobacco, heated tobacco, shisha, cannabis, or non-tobacco nicotine products like e-cigarettes or nicotine pouches. People using these products alongside daily tobacco smoking will still be eligible. 2. Only one person per household may be enrolled |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centre
United Kingdom
Sponsor information
University/education
RGEA
Joint Research Office
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 616480 |
|---|---|
| rgea.sponsor@admin.ox.ac.uk | |
| Website | https://researchsupport.admin.ox.ac.uk/contacts/rgea |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Participants: We will send study results to each participant and other stakeholders. Previously we have produced videos, podcasts, and infographics and will do this here, as appropriate. The PI hosts the podcast ‘Let’s Talk E-cigarettes’ where investigators of relevant studies are interviewed about their work. Members of the public are one of the key audiences for this podcast and it has over 9,000 listeners in more than 53 countries. The proposed work would be a relevant study that could be featured. Implementation: With NCSCT, we will produce an intervention manual for our new brief intervention for financial advice settings, using insights from our process evaluation, and disseminating to >95,000 health and social care professionals. We will work with ASH to disseminate our findings to contacts across health and social care through direct communications, webinars, and briefing documents developed through collaboration. We will work with our financial advice partners to find the best ways to reach others in the sector. ASH provide the secretariat for the All-Party Parliamentary Group on Smoking and Health and so where relevant can provide advice on engaging with parliamentarians regarding our findings. Scientific community: We will present at academic conferences and publish our findings in peer-reviewed journals. Members of the public: We will use insights from previous PPI work on tobacco control dissemination (https://bit.ly/2QSyo46), our PPI contributors, and our process evaluation to inform communication to the public. Our PPI contributors will aid us in co-creation of dissemination materials and strategy. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made avaliable at a later date. |
Editorial Notes
27/08/2025: The following changes were made to the study record:
1. The date of first enrolment was changed from 01/10/2025 to 01/12/2025.
2. The date of last enrolment was changed from 31/10/2028 to 31/12/2027.
13/05/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
