Biomaterial Database

The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial. 2020

Lesley Sinclair, and Margaret McFadden, and Helen Tilbrook, and Alex Mitchell, and Ada Keding, and Judith Watson, and Linda Bauld, and Frank Kee, and David Torgerson, and Catherine Hewitt, and Jennifer McKell, and Pat Hoddinott, and Fiona M Harris, and Isabelle Uny, and Kathleen Boyd, and Nicola McMeekin, and Michael Ussher, and David M Tappin, and

Usher Institute, University of Edinburgh, Teviot Place, Edinburgh, EH8 9AG, UK.

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? CONCLUSIONS 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. BACKGROUND Current Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

UI	MeSH Term	Description	Entries
D009042	Motivation	Those factors which cause an organism to behave or act in either a goal-seeking or satisfying manner. They may be influenced by physiological drives or by external stimuli.	Incentives,Disincentives,Expectations,Disincentive,Expectation,Incentive,Motivations
D009660	Northern Ireland	The northern one-sixth of the island of Ireland - between the North Atlantic Ocean and the North Sea; northwest of France. The capital is Belfast.
D011247	Pregnancy	The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.	Gestation,Pregnancies
D011295	Prenatal Care	Care provided the pregnant woman in order to prevent complications, and decrease the incidence of maternal and prenatal mortality.	Antenatal Care,Care, Antenatal,Care, Prenatal
D003362	Cost-Benefit Analysis	A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. In contrast a cost effectiveness in general compares cost with qualitative outcomes.	Cost and Benefit,Cost-Benefit Data,Benefits and Costs,Cost Benefit,Cost Benefit Analysis,Cost-Utility Analysis,Costs and Benefits,Economic Evaluation,Marginal Analysis,Analyses, Cost Benefit,Analysis, Cost Benefit,Analysis, Cost-Benefit,Analysis, Cost-Utility,Analysis, Marginal,Benefit and Cost,Cost Benefit Analyses,Cost Benefit Data,Cost Utility Analysis,Cost-Benefit Analyses,Cost-Utility Analyses,Data, Cost-Benefit,Economic Evaluations,Evaluation, Economic,Marginal Analyses
D004739	England	A part of Great Britain within the United Kingdom.
D005260	Female		Females
D005378	Financial Support	The provision of monetary resources including money or capital and credit; obtaining or furnishing money or capital for a purchase or enterprise and the funds so obtained. (From Random House Unabridged Dictionary, 2d ed.)	Financial Supports,Support, Financial,Supports, Financial
D005500	Follow-Up Studies	Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.	Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man