Advancing, promoting and sharing knowledge of health through excellence in teaching, clinical practice and research into the prevention and treatment of illness

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial.

Sinclair, L; McFadden, M; Tilbrook, H; Mitchell, A; Keding, A; Watson, J; Bauld, L; Kee, F; Torgerson, D; Hewitt, C; et al. Sinclair, L; McFadden, M; Tilbrook, H; Mitchell, A; Keding, A; Watson, J; Bauld, L; Kee, F; Torgerson, D; Hewitt, C; McKell, J; Hoddinott, P; Harris, FM; Uny, I; Boyd, K; McMeekin, N; Ussher, M; Tappin, DM; CPIT III local research teams (2020) The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial. Trials, 21 (1). p. 183. ISSN 1745-6215
SGUL Authors: Ussher, Michael Henry

PDF Published Version
Available under License Creative Commons Attribution.

Download (1MB) | Preview


BACKGROUND: Eighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? METHODS: The Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n = 940) are pregnant smokers (age > 16 years, < 24 weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6 months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6 months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK? DISCUSSION: This phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

Item Type: Article
Additional Information: © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Keywords: Financial incentives, Intervention, Maternal and child health, Outcomes, Pregnancy, Prevention, Randomised controlled trial, Smoking cessation, CPIT III local research teams, Cardiovascular System & Hematology, General & Internal Medicine, 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Trials
ISSN: 1745-6215
Language: eng
14 February 2020Published
30 December 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
Project IDFunderFunder ID
HIPS/16/1Chief Scientist Office, Scottish Government Health and Social Care DirectorateUNSPECIFIED
C48006/A20863Cancer Research UK
2017_09Chest Heart and Stroke Northern IrelandUNSPECIFIED
COM/5352/17HSC Research and Development DivisionUNSPECIFIED
272Lullaby Trust
PubMed ID: 32059684
Go to PubMed abstract
Publisher's version:

Actions (login required)

Edit Item Edit Item