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Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis.

Whitemore, R; Leonardi-Bee, J; Naughton, F; Sutton, S; Cooper, S; Parrott, S; Hewitt, C; Clark, M; Ussher, M; Jones, M; et al. Whitemore, R; Leonardi-Bee, J; Naughton, F; Sutton, S; Cooper, S; Parrott, S; Hewitt, C; Clark, M; Ussher, M; Jones, M; Torgerson, D; Coleman, T (2019) Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis. Trials, 20 (1). p. 280. ISSN 1745-6215 https://doi.org/10.1186/s13063-019-3341-4
SGUL Authors: Ussher, Michael Henry

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Abstract

BACKGROUND: Smoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called 'MiQuit' to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit's evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy. METHODS/DESIGN: This is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks' gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks' gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate. DISCUSSION: If effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03231553 . Registered on 20 July 2017.

Item Type: Article
Additional Information: © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), 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 (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: Pregnancy, Protocol, Randomised controlled trial, Self-help, Smoking cessation, 1102 Cardiovascular Medicine And Haematology, 1103 Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Trials
ISSN: 1745-6215
Language: eng
Dates:
DateEvent
22 May 2019Published
2 April 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
C11232/A23434Cancer Research UKhttp://dx.doi.org/10.13039/501100000289
RP-PG-0109-10020National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 31118090
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/110897
Publisher's version: https://doi.org/10.1186/s13063-019-3341-4

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