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The Smoking Cessation in Pregnancy Incentives Trial (CPIT III): A Multi-centre phase III Randomised Controlled Trial

Background

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. NICE have asked for evidence from a multi-centre trial.

Aims

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.

Methods

This 39 month trial will recruit 940 smokers over 18-24 months in 2-4 UK centres and follow them until 6 months after birth. The extra cost and long-term benefits will be used to calculate the cost per Quality Adjusted Life Year gained. Pregnant smokers attending their first maternity booking appointment will be invited to participate. All participants will be offered usual smoking cessation services. In addition, the intervention group will be offered up to £400 of shopping vouchers, £50 if they attend counselling and set a quit date, £50 if proven quit 4-weeks later, £100 if quit after 12 weeks, and £200 if quit near the end of pregnancy. Self-report in late pregnancy and 6 months after birth will be verified by saliva cotinine, a nicotine metabolite. The trial includes a qualitative process evaluation which has two main aims:

1) To understand the mechanisms of identification and referral of pregnant women to smoking cessation services in each geographical area.

2) To understand the varied contexts in which smoking cessation services operate so that facilitators and barriers to implementation in a range of contexts, including diverse populations can be identified.

Outputs

Protocol: Sinclair, L., McFadden, M., Tilbrook, H. et al. The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial. Trials 21, 183 (2020). https://doi.org/10.1186/s13063-019-4042-8

Results: Tappin D, Sinclair L, Kee F, McFadden M, Robinson-Smith L, Mitchell A et al. Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial BMJ 2022; 379 :e071522 doi:10.1136/bmj-2022-071522

Qualitative: McKell J, Harris FM, Sinclair L, et alUsual care in a multicentre randomised controlled trial of financial incentives for smoking cessation in pregnancy: qualitative findings from a mixed-methods process evaluationBMJ Open 2022;12:e066494. doi: 10.1136/bmjopen-2022-066494

Cost Effectiveness: McMeekin N, Sinclair L, Robinson-Smith L, Mitchell A, Bauld L, Tappin DM, et al. Financial incentives for quitting smoking in pregnancy: Are they cost-effective? Addiction. 2023; 118(8): 1445–1456. https://doi.org/10.1111/add.16176

Economic Evaluation: McMeekin N, Sinclair L, Bauld L, et alA protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III)BMJ Open 2020;10:e038827. doi: 10.1136/bmjopen-2020-038827

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Funding

Funder (s):

Cancer Research UK, Chief Scientist Office Scottish Government, Health and Social Care Services Northern Ireland, Chest Heart and Stroke Northern Ireland, Lullaby Trust, Scottish Cot Death Trust
Start date: September 2017
End date February 2021

Members

Internal Staff

External Collabortators

Trials and Statistics Research in the Department of Health Sciences