Open Access Study protocol

The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial

David M Tappin1*, Linda Bauld2, Carol Tannahill3, Linda de Caestecker4, Andrew Radley5, Alex McConnachie6, Kathleen Boyd7, Andrew Briggs7, Liz Grant8, Alan Cameron9, Susan MacAskill2, Lesley Sinclair2, Brenda Friel4 and Tim Coleman10

Author Affiliations

1 Paediatric Epidemiology and Community Health Unit, Section of Child Health, Division of Developmental Medicine, Glasgow University, Yorkhill Campus, Glasgow G3 8SJ, Scotland, U.K

2 Centre for Tobacco Control Studies, and School of Management, University of Stirling, Stirling, FK9 4LA, Scotland, U.K

3 Glasgow Centre for Population Health, 1st Floor, House 6, 94 Elmbank Street, Glasgow, G2 4DL, Scotland, U.K

4 NHS Greater Glasgow& Clyde, J B Russell House, Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, G12 OXH, Scotland, U.K

5 Directorate of Public Health, NHS Tayside, Kings Cross Hospital, Clepington Road, Dundee, DD3 8EA, Scotland, U.K

6 Robertson Centre for Biostatistics. Boyd Orr Building, University Avenue, Glasgow, G12 8QQ, Scotland, U.K

7 Institute of Health and Wellbeing, University of Glasgow, 1 Lilybank Gardens, Glasgow, G12 8RZ, Scotland, U.K

8 NHS Greater Glasgow and Clyde, West House, Gartnavel Royal Hospital, Glasgow, G12 0XH, Scotland, U.K

9 R205 Level 2, Queen Mother’s Hospital Tower Block, Glasgow, G3 8SJ, Scotland, U.K

10 U.K. Centre for Tobacco Control Studies and NIHR School for Primary Care Research Division of Primary Care, University of Nottingham, Nottingham, NG7 2UH, Scotland, U.K

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Trials 2012, 13:113  doi:10.1186/1745-6215-13-113

Published: 20 July 2012

Abstract

Background

Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit?

Design and methods

This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy.

Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without introducing outcome bias? Can incentives be introduced in a way that is feasible and acceptable?

Discussion

This phase II trial will establish a workable design to reduce the risks associated with a future definitive phase III multicenter randomized controlled trial and establish a framework to assess the costs and benefits of financial incentives to help pregnant smokers to quit.

Trial registration

Current Controlled Trials ISRCTN87508788

Keywords:
Intervention; Maternal and child health; Outcomes; Pregnancy; Prevention; Smoking