The smoking cessation in pregnancy incentives trial
| ISRCTN | ISRCTN15236311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15236311 |
| Secondary identifying numbers | CPMS 36323 |
- Submission date
- 09/10/2017
- Registration date
- 13/10/2017
- Last edited
- 05/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Current plain English summary as of 04/02/2019:
Background and study aims
Lifelong smokers lose 10 years of life. Smoking cessation by age 40 leads to a near normal lifespan. Eighty percent of women have a baby, most by age 40, making pregnancy an opportunity to help women quit before their health is irreversibly compromised. Few of the UK's current 130,000 pregnant smokers quit despite free counselling and Nicotine Replacement Therapy. Offering financial incentives for smoking cessation has worked in local single site trials including in Glasgow where the pilot study for this trial took place. The aim of this study is to examine the effectiveness and cost effectiveness of offering financial incentives in the form of shopping vouchers to pregnant smokers to engage with smoking cessation services, quit smoking during pregnancy and stay quit after pregnancy.
Who can participate?
Pregnant women (less than 24 weeks) aged 16 and older who smoke.
What does the study involve?
Participants are randomly allocated to one of two groups. All participants receive an offer to attend counselling sessions to help them stop smoking. Those in the first group receive a £50 shopping voucher if they provide data about their smoking late in their pregnancy and a £25 shopping voucher if they provide data six months after giving birth. Those in the second group receive the offer of up to £400 in shopping vouchers if they attend face-to-face counselling appointments and setting a quit smoking date. Participants are followed up to see if they have stopped smoking through questionnaires (confirmed by urine or saliva samples).
What are the possible benefits and risks of participating?
All the methods of support offered during the study have been shown to be very safe. Direct benefits of taking part include the 50% chance of receiving the financial incentive vouchers worth £400. However, only participants who manage to give up smoking will receive the vouchers. Giving up smoking will help the health of the woman and that of their baby in the short and longer term.
The results of the study will enable policy makers to determine whether financial incentives should be recommend for use in NHS smoking cessation services to help stop pregnant women from smoking.
Where is the study run from?
1. Wishaw General Hospital (UK)
2. Queen’s University Belfast (UK)
3. Wessex England (UK) – Salisbury, Poole, Portsmouth, Isle of Wight, Dorchester
When is the study starting and how long is it expected to run for?
September 2017 to November 2020
Who is funding the study?
1. Cancer Research UK (UK)
2. Chest Heart and Stroke Northern Ireland (UK)
3. The Lullaby Trust (UK)
4. Public Health Agency for Northern Ireland (UK)
5. Scottish Government Chief Scientist Office (CSO) (UK)
6. Scottish Cot Death Trust (UK)
Who is the main contact?
Professor David M Tappin
david.tappin@glasgow.ac.uk
Previous plain English summary:
Background and study aims
Lifelong smokers lose 10 years of life. Smoking cessation by age 40 leads to a near normal lifespan. Eighty percent of women have a baby, most by age 40, making pregnancy an opportunity to help women quit before their health is irreversibly compromised. Few of the UK's current 130,000 pregnant smokers quit despite free counselling and Nicotine Replacement Therapy. Offering financial incentives for smoking cessation has worked in local single site trials including in Glasgow where the pilot study for this trial took place. The aim of this study is to examine the effectiveness and cost effectiveness of offering financial incentives in the form of shopping vouchers to pregnant smokers to engage with smoking cessation services, quit smoking during pregnancy and stay quit after pregnancy.
Who can participate?
Pregnant women (less than 24 weeks) aged 16 and older who smoke.
What does the study involve?
Participants are randomly allocated to one of two groups. All participants receive an offer to attend counselling sessions to help them stop smoking. Those in the first group receive a £50 shopping voucher if they provide data about their smoking late in their pregnancy and a £25 shopping voucher if they provide data six months after giving birth. Those in the second group receive the offer of up to £400 in shopping vouchers if they attend face-to-face counselling appointments and setting a quit smoking date. Participants are followed up to see if they have stopped smoking through questionnaires (confirmed by urine or saliva samples).
What are the possible benefits and risks of participating?
All the methods of support offered during the study have been shown to be very safe. Direct benefits of taking part include the 50% chance of receiving the financial incentive vouchers worth £400. However, only participants who manage to give up smoking will receive the vouchers. Giving up smoking will help the health of the woman and that of their baby in the short and longer term.
The results of the study will enable policy makers to determine whether financial incentives should be recommend for use in NHS smoking cessation services to help stop pregnant women from smoking.
Where is the study run from?
1. Wishaw General Hospital (UK)
2. Queen’s University Belfast (UK)
When is the study starting and how long is it expected to run for?
September 2017 to November 2020
Who is funding the study?
1. Cancer Research UK (UK)
2. Chest Heart and Stroke Scotland (UK)
3. The Lullaby Trust (UK)
4. National Cancer Research Institute (UK)
5. Public Health Agency for Northern Ireland (UK)
6. Scottish Government Chief Scientist Office (CSO) (UK)
7. Yorkshire Cancer Research (UK)
Who is the main contact?
Professor David M Tappin
david.tappin@glasgow.ac.uk
Contact information
Scientific
University of Glasgow
Scottish Cot Death Trust
5th Floor, West Glasgow Ambulatory Care Hospital
Dalnair Street
Yorkhill
Glasgow
G3 8SJ
United Kingdom
 ORCID ID |
0000-0001-8914-055X |
|---|---|
| Phone | +44 (0)7784 304568 |
| david.tappin@glasgow.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Prevention, Other |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | ISRCTN15236311_PIS_V1.4_01Aug19.pdf |
| Scientific title | The Smoking Cessation in Pregnancy Incentives Trial: A multi-centre phase III randomised controlled trial |
| Study acronym | CPIT III |
| Study objectives | The aim of this study is to conduct a pivotal phase III randomised controlled multi-centre trial to examine the effectiveness and cost effectiveness of offering financial incentives in the form of shopping vouchers to pregnant smokers to engage with smoking cessation services, quit smoking during pregnancy and stay quit after pregnancy. |
| Ethics approval(s) | West of Scotland REC 4, 16/08/2017, ref: 17/WS/0173 |
| Health condition(s) or problem(s) studied | Smoking during pregnancy |
| Intervention | Current interventions as of 10/05/2018: Participants are randomly allocated to either the intervention or the control group. The intervention group and control group receive the offer of smoking cessation services support which includes a face to face counselling appointment (in some areas within individual trial sites, the face to face contact may be within pharmacy services). Participants in both groups receive a £50 shopping voucher if they provide data at the primary outcome time point (late pregnancy) and a £25 shopping voucher if they provide data at the secondary outcome time point (6 months post-partum). (If a participant does not provide primary outcome data, they are still able to receive a £25 shopping voucher if they provide secondary outcome data). Intervention: In addition, the intervention group receive the offer of up to £400 of shopping vouchers: £50 for attending the first routine face-to-face counselling appointment at the smoking services support meeting and setting a quit smoking date, £50 if quit 4 weeks later verified by exhaled carbon monoxide (CO) at the accepted level for a non-smoker at the site, £100 if CO verified quit 12 weeks post quit date, £200 if CO verified quit at 34-38 weeks gestation. Control group: The control group receives the offer of smoking cessation services support which includes a face to face counselling appointment. They also receive a £50 shopping voucher if they provide data at the primary outcome time point (late pregnancy) and a £25 shopping voucher if they provide data at the secondary outcome time point (6 months post-partum). Previous interventions: Participants are randomly allocated to either the intervention or the control group. The intervention group and control group receive the offer of smoking cessation services support which includes a face to face counselling appointment (in some areas within individual trial sites, the face to face contact may be within pharmacy services). Participants in both groups receive a £50 shopping voucher if they provide data at the primary outcome time point (late pregnancy) and a £25 shopping voucher if they provide data at the secondary outcome time point (6 months post-partum). (If a participant does not provide primary outcome data, they are still able to receive a £25 shopping voucher if they provide secondary outcome data). Intervention: In addition, the intervention group receive the offer of up to £400 of shopping vouchers: £50 for attending the first routine face-to-face counselling appointment at the smoking services support meeting and setting a quit smoking date, £50 if quit 4 weeks later verified by exhaled carbon monoxide (CO) <10 parts/million, £100 if CO verified quit 12 weeks post quit date, £200 if CO verified quit at 34-38 weeks gestation. Control group: The control group receives the offer of smoking cessation services support which includes a face to face counselling appointment. They also receive a £50 shopping voucher if they provide data at the primary outcome time point (late pregnancy) and a £25 shopping voucher if they provide data at the secondary outcome time point (6 months post-partum). |
| Intervention type | Other |
| Primary outcome measure | Self-reported abstinence from smoking for at least eight weeks prior to 34-38 weeks gestation verified by cotinine and/or anabasine in urine/saliva. |
| Secondary outcome measures | 24/07/2020: Secondary outcome measures updated to include those items omitted in error at trial registration and thus correspond with the published protocol: 1. Engagement with smoking cessation services measured as having attended a first appointment with a Stop Smoking Service Advisor and setting a quit date before 26 weeks gestation 2. Biochemically validated (CO) self-reported abstinence from smoking at 4 weeks after quit date 3. Cotinine and/or anabasine verified self-reported continuous abstinence from smoking until 6 months after birth 4. Birth weight 5. Cost-effectiveness: incremental cost per late pregnancy quitter and cost per quality-adjusted life year (QALY) gained over the trial time horizon and lifetime using the EQ-5D as the measure of utility at baseline, primary and secondary outcome data collection follow-up time points 6. Process evaluation: barriers and facilitators to trial recruitment and future implementation of incentives in practice using a mixed methods longitudinal case study design informed by the realist evaluation approach Data for the primary outcome and secondary outcomes 1, 2 and 4 will be combined with data from the feasibility trial in a meta-analysis Previous secondary outcome measures listed: Cotinine and/or anabasine verified self-reported continuous abstinence from smoking until 6 months after birth, birth weight, cost effectiveness (using the EQ-5D as the measure of utility) and process evaluation. |
| Overall study start date | 01/09/2017 |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 940; UK Sample Size: 940 |
| Total final enrolment | 944 |
| Key inclusion criteria | 1. Self-reported smoker 2. >= 16 years 3. Pregnant less than 24 weeks 4. English speaking |
| Key exclusion criteria | 1. Non-smoker 2. <16 years 3. Pregnant > = 24 weeks 4. Non-English speaking |
| Date of first enrolment | 01/02/2018 |
| Date of final enrolment | 04/04/2020 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Wishaw
ML2 0DP
United Kingdom
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Assistant Portfolio Manager, amanda.pattie@nihr.ac.uk
University Hospital Southampton NHS Foundation Trust
Unit 7
Berrywood Business Village
Tollbar Way
Hedge End
Southampton
SO30 2UN
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Research & Development
Ward 11 Dykebar Hospital
Grahamstone Road
Paisley
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)141 314 4011 |
|---|---|
| Emma.McDonough@ggc.scot.nhs.uk | |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Northern Ireland Chest Heart & Stroke, Northern Ireland Chest Heart & Stroke's, NI Chest Heart & Stroke's, Northern Ireland Chest, Heart and Stroke, nichestheartandstroke, NI Chest Heart & Stroke - Belfast, NICHS
- Location
- United Kingdom
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Lullaby Trust, The Foundation for the Study of Infant Deaths, The Lullaby Trust Sales Limited, FSID
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- PHA
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 31/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 07/02/2019: The trial results will be submitted for publication in a high-impact peer-reviewed journal one year after the trial end date. The trial protocol will be submitted for publication in a peer-reviewed journal in Spring 2019. Previous publication and dissemination plan: The trial results will be submitted for publication in a high-impact peer-reviewed journal one year after the trial end date. The trial protocol will be submitted for publication in a peer-reviewed journal in Spring 2018. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Trial participants give informed consent that the information collected about them will be used to support other research in the future and may be shared anonymously with other researchers. All the individual participant data collected during the trial, after de-identification, and the study protocol, SAP and data key describing each variable will be available. Other documents can be requested for consideration from the team. This data will be made available immediately following the main publications of the clinical effectiveness and cost-effectiveness findings with no end date. Requests may be made by researchers who provide a methodologically sound proposal for any purpose/analysis. Proposals should be directed to the Chief Investigators at David.Tappin@glasgow.ac.uk and linda.bauld@ed.ac.uk, and will be reviewed by the trial team. To gain access, data requestors will need to complete a data request form provided by York Trials Unit and sign a data confidentiality agreement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 14/02/2020 | 17/02/2020 | Yes | No | |
| Participant information sheet | version V1.4 | 01/08/2019 | 23/07/2020 | No | Yes |
| Protocol article | 27/10/2020 | 21/09/2021 | Yes | No | |
| Statistical Analysis Plan | version 1.1 | 28/07/2021 | 21/09/2021 | No | No |
| Preprint results | 22/06/2022 | 24/06/2022 | No | No | |
| Results article | 19/10/2022 | 20/10/2022 | Yes | No | |
| Other publications | Qualitative findings from a mixed-methods process evaluation | 07/12/2022 | 06/01/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Cost-effectiveness analysis and cost-utility analysis | 15/03/2023 | 05/11/2024 | Yes | No |
Additional files
- ISRCTN15236311_PIS_V1.4_01Aug19.pdf
- Uploaded 23/07/2020
- 34272 SAP_v1.1_28July2021.pdf
Editorial Notes
05/11/2024: Publication reference added.
06/01/2023: Publication reference added.
20/10/2022: Publication reference added.
24/06/2022: Preprint reference added.
21/09/2021: Publication reference added and the statistical analysis plan was uploaded as an additional file.
01/03/2021: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2021 to 30/11/2021.
2. The intention to publish date has been changed from 31/08/2021 to 31/03/2022.
3. The total final enrolment number has been added.
29/07/2020: IPD sharing statement added.
24/07/2020: The following changes were made to the trial record:
1. Sponsor contact details and secondary outcome measures updated.
2. The recruitment end date was changed from 31/03/2020 to 04/04/2020.
23/07/2020: The following changes were made to the trial record:
1. The secondary outcome measures and sponsor contact details were updated.
2. Some changes were made to the trial protocol participant follow-up procedures during COVID-19. These changes are not reflected in the published protocol.
3. The participant information sheet has been uploaded.
17/02/2020: Publication reference added.
08/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 31/03/2020.
2. The overall trial end date has been changed from 30/11/2020 to 28/02/2021.
03/04/2019: The condition has been changed from "Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other obstetric conditions, not elsewhere classified" to "Smoking during pregnancy" following a request from the NIHR.
07/02/2019: The publication and dissemination plan was updated.
04/02/2019: The following changes were made:
1. The funders were updated.
2. The trial participating centres were updated.
3. The recruitment start date was changed from 01/11/2017 to 01/02/2018.
4. The recruitment end date was changed from 28/02/2019 to 31/12/2019.
5. The intention to publish date was changed from 28/02/2020 to 31/08/2021.
6. The plain English summary was updated.
10/05/2018: The interventions have been changed.
