Taylor Adrian, Thompson Tom P, Ussher Michael, Aveyard Paul, Murray Rachael L, Harris Tess, Creanor Siobhan, Green Colin, Streeter Adam Justin, Chynoweth Jade, Ingram Wendy, Greaves Colin J, Hancocks Helen, Snowsill Tristan, Callaghan Lynne, Price Lisa, Horrell Jane, King Jennie, Gude Alex, George Mary, Wahlich Charlotte, Hamilton Louisa, Cheema Kelisha, Campbell Sarah, Preece Dan
School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK
School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.
BMJ Open. 2020 Dec 1;10(12):e043331. doi: 10.1136/bmjopen-2020-043331.
Smoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.
A pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.
Approved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.
ISRCTN47776579; Pre-results.
减少吸烟量有助于提高戒烟成功率。本研究旨在确定以客户为中心的减少吸烟（及戒烟）和增加（或以其他方式进行）身体活动（PA）的动机支持方案，是否能帮助那些不希望立即戒烟的吸烟者减少吸烟量，并最终实现戒烟。本文报告了该研究的设计和方法。
一项务实的、多中心的、平行的、两组随机对照优势临床试验，包含嵌入式过程评估和经济学评估。希望减少吸烟量且无立即戒烟计划的参与者按1:1随机分组，分别接受以下两种干预措施：（1）由量身定制的个人健康教练提供面对面和/或电话支持，以减少吸烟量并增加身体活动，辅助减少吸烟（干预组）；（2）提供简短的书面/电子戒烟建议（对照组）。试验两组的参与者还会被引导至当地常规的减少吸烟和戒烟支持机构。主要结局指标是在基线后3个月和9个月通过邮寄问卷进行参与者自我报告戒烟后，6个月时经一氧化碳确认的持续延长戒烟期。在9个月时被确认为已戒烟的参与者将在15个月时接受随访。
经西南布里斯托尔国民保健服务研究委员会批准（17/SW/0223）。传播内容将包括在同行评审期刊上发表所述结局的研究结果、平行过程评估和经济学评估。研究结果将传达给试验参与者和医疗服务提供者。
ISRCTN47776579；预结果。
