Cooper Sue, Foster Katharine, Naughton Felix, Leonardi-Bee Jo, Sutton Stephen, Ussher Michael, Leighton Matthew, Montgomery Alan, Parrott Steve, Coleman Tim
Division of Primary Care, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK.
Trials. 2015 Jan 27;16:29. doi: 10.1186/s13063-014-0546-4.
Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised controlled trial (RCT) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated, tailored text message intervention called MiQuit. This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service settings aimed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop.
METHODS/DESIGN: This will be a multi-centre, parallel group RCT. Participants are being identified in 16 English antenatal care settings and must be >16 years old, pregnant, <25 weeks gestation, smoke >1 daily cigarette, have smoked >5 daily cigarettes before pregnancy, and able to understand texts in English. After consenting and the collection of baseline data, participants are randomised to control or intervention groups in a 1:1 ratio; randomisation is stratified by trial site and gestation and employs computer-generated pseudo-random code using random permuted blocks of randomly varying size, and held on a secure server. All participants receive a National Health Service (NHS) leaflet aimed at helping them to stop smoking. Intervention group women also receive the 12-week MiQuit programme of tailored, supportive, interactive text message, self-help cessation support. Women are followed up by telephone 4 weeks after randomisation and at 36 weeks gestation. The study aims to recruit 400 women, and with this sample we will be able to estimate trial centres' recruitment rates to within +/-1% (margin of error = half width of 95% confidence interval); individual trial groups' ascertainment of rates for smoking outcomes between 4 weeks after randomisation until approximately 36 weeks gestation to within +/-4%, and across both groups, the combined cessation rate at 36 weeks +/-3%.
Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy.
ClinicalTrials.gov NCT02043509 Registered 14 January 2014.
孕期吸烟是一个公共卫生问题。自助戒烟支持有助于孕妇戒烟，但通过短信提供这种支持的效果尚不清楚。之前的一项随机对照试验（RCT）证明了使用名为MiQuit的自动化、个性化短信干预措施为孕期吸烟者提供此类支持的可行性和可接受性。这项更大规模的RCT将估计关键参数，并测试在英国国家医疗服务体系环境中开展一项大型试验的可行性，该试验旨在为MiQuit帮助孕期吸烟者戒烟的效用提供确凿证据。
方法/设计：这将是一项多中心、平行组RCT。在16个英国产前护理机构中识别参与者，参与者必须年满16岁、怀孕、妊娠<25周、每天吸烟>1支、怀孕前每天吸烟>5支，并且能够理解英文文本。在获得同意并收集基线数据后，参与者按1:1的比例随机分配到对照组或干预组；随机化按试验地点和孕周分层，并使用随机排列的大小随机变化的块生成计算机生成的伪随机代码，保存在安全的服务器上。所有参与者都会收到一份旨在帮助他们戒烟的英国国家医疗服务体系（NHS）宣传册。干预组的女性还会收到为期12周的MiQuit计划，该计划包括个性化、支持性、交互式短信自助戒烟支持。在随机分组后4周和妊娠36周时通过电话对女性进行随访。该研究旨在招募400名女性，有了这个样本，我们将能够估计试验中心的招募率在±1%以内（误差幅度=95%置信区间的半宽度）；各个试验组在随机分组后4周直至妊娠约36周期间吸烟结果发生率的确定在±4%以内，两组综合计算，36周时的戒烟率在±3%以内。
试点试验的完成将提供数据，以便为一项确定MiQuit是否对孕期戒烟有效的确定性试验进行规划。
ClinicalTrials.gov NCT02043509，2014年1月14日注册。
