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

Whitemore, Rachel; Leonardi-Bee, Jo; Naughton, Felix; Sutton, Stephen; Cooper, Sue; Parrott, Steve; Hewitt, Catherine; Clark, Miranda; Ussher, Michael; Jones, Matthew; Torgerson, David; Coleman, Tim

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 currently-available message programmes are not appropriate for use in pregnancy. A 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 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: A multi-centre, parallel group RCT. Pregnant women over 16 years, less than 25 weeks gestation who smoke one or more daily cigarettes but smoked at least 5 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, 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.

Citation

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 and meta-analysis. Trials, 20, 1-13. https://doi.org/10.1186/s13063-019-3341-4

• Journal Article Type: Article
• Acceptance Date: Apr 2, 2019
• Online Publication Date: May 22, 2019
• Publication Date: May 22, 2019
• Deposit Date: Apr 8, 2019
• Publicly Available Date: Apr 8, 2019
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 20
• Article Number: 280
• Pages: 1-13
• DOI: https://doi.org/10.1186/s13063-019-3341-4
• Keywords: Smoking cessation; Pregnancy; Self-help; Randomised controlled trial; Protocol
• Public URL: https://nottingham-repository.worktribe.com/output/1763095
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3341-4
• Additional Information: Received: 1 May 2018; Accepted: 2 April 2019; First Online: 22 May 2019; : Ethical approval for this trial was granted by East Midlands – Nottingham 1 Research Ethics Committee (NRES reference 17/EM/0327).Informed consent to participate in the study will be obtained from participants.; : Not applicable.; : On two occasions since 2008, TC has been paid to attend and present at symposia arranged by Pierre Fabre Laboratories (PFL); PFL is a manufacturer of nicotine replacement therapy.All other authors have no competing interests.; : Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
• Contract Date: Apr 8, 2019