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“HelpMeDoIt!”随机对照可行性试验研究方案:一款基于应用程序、网络和社会支持的肥胖成年人减肥干预措施。

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

机构信息

MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.

College of Engineering, Mathematics, and Physical Sciences, Data Science Institute, University of Exeter, Exeter, UK.

出版信息

BMJ Open. 2017 Oct 25;7(10):e017159. doi: 10.1136/bmjopen-2017-017159.


DOI:10.1136/bmjopen-2017-017159
PMID:29074513
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5665248/
Abstract

INTRODUCTION: HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). AIM: To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. METHODS AND ANALYSIS: 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI) 30 kg/m and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention. ETHICS AND DISSEMINATION: The protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN85615983.

摘要

简介:HelpMeDoIt!将测试一种使用智能手机应用程序和网站的创新减肥干预措施的可行性。目标设定、自我监测和社会支持是行为改变的三个关键促进因素。HelpMeDoIt!包含这些功能,并鼓励参与者邀请社交圈中的“助手”来帮助他们实现目标。

目的:测试该干预措施在支持肥胖成年人实现减肥目标方面的可行性。

方法和分析:为期 12 个月的可行性随机对照试验和伴随的过程评估。参与者(n=120)将是有兴趣减肥的成年人,体重指数(BMI)为 30kg/m,并且是智能手机用户。干预组将使用应用程序/网站 12 个月。参与者将提名一个或多个助手来支持他们。助手可以访问应用程序/网站。对照组将收到一份关于健康生活方式的传单,并在随访后可以使用 HelpMeDoIt!。研究的主要结果是是否符合预定的进展标准,以便进行更大的随机对照有效性试验。数据将在基线、6 个月和 12 个月时收集。结果重点探索提供干预措施的可行性,包括:(i)评估三个主要结果(BMI、身体活动和饮食);(ii)次要结果包括腰围/臀围、健康相关生活质量、社会支持、自我效能、动机和心理健康;(iii)招募和保留;(iv)国民保健服务(NHS)资源使用和参与者承担的费用;(v)应用程序/网站的可用性和可接受性;(vi)对最多 50 名参与者和 20 名助手进行干预体验的定性访谈。统计分析将集中于可行性结果,并提供干预效果的初步估计。定性访谈的主题分析将评估实施、可接受性、影响因素和影响干预的环境因素。

伦理和传播:该方案已获得西苏格兰国民保健服务研究伦理委员会(Ref:15/WS/0288)和格拉斯哥大学 MVLS 学院伦理委员会的批准(Ref:200140108)。研究结果将通过同行评审出版物和会议报告广泛传播。

试验注册号:ISRCTN85615983。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7412/5665248/088ea70087e5/bmjopen-2017-017159f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7412/5665248/edb50c1da557/bmjopen-2017-017159f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7412/5665248/088ea70087e5/bmjopen-2017-017159f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7412/5665248/edb50c1da557/bmjopen-2017-017159f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7412/5665248/088ea70087e5/bmjopen-2017-017159f02.jpg

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