Smoking, nicotine and pregnancy 2 (SNAP2) trial: Protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy

Clark, Miranda M., Cooper, Sue, Naughton, Felix, Ussher, Michael, Emery, Joanne ORCID: https://orcid.org/0000-0002-8915-7033, McDaid, Lisa ORCID: https://orcid.org/0000-0001-5032-2380, Thomson, Ross, Phillips, Lucy, Bauld, Linda, Aveyard, Paul, Torgerson, David, Berlin, Ivan, Lewis, Sarah, Parrott, Steve, Hewitt, Catherine, Welch, Charlie, Parkinson, Gill, Dickinson, Anne, Sutton, Stephen, Brimicombe, James, Bowker, Katharine, McEwen, Andrew, Vedhara, Kavita and Coleman, Tim (2024) Smoking, nicotine and pregnancy 2 (SNAP2) trial: Protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy. BMJ Open, 14 (5). ISSN 2044-6055

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Abstract

Introduction Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. Methods and analysis A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. Ethics and dissemination Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. Trial registration number ISRCTN16830506. Protocol version 5.0, 10 Oct 2023.

Item Type: Article
Additional Information: Funding Information: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research [Grant Reference Number RP-PG- 0615-20003]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. TC is an NIHR Senior Investigator. PA is an NIHR senior investigator and is funded by NIHR Oxford Biomedical Research Centre, NIHR Oxford Health Biomedical Research Centre, and NIHR Oxford and Thames Valley Applied Research Collaboration.
Uncontrolled Keywords: maternal medicine,public health,respiratory medicine (see thoracic medicine),smoking reduction,medicine(all),sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging
Faculty of Medicine and Health Sciences > Research Groups > Behavioural and Implementation Science
Faculty of Medicine and Health Sciences > Research Groups > Health Promotion
Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
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Depositing User: LivePure Connector
Date Deposited: 02 Jul 2024 16:32
Last Modified: 10 Jul 2024 01:53
URI: https://ueaeprints.uea.ac.uk/id/eprint/95767
DOI: 10.1136/bmjopen-2024-087175

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