Aim2Be 移动医疗干预超重和肥胖儿童:一项随机对照试验的研究方案。
Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial.
机构信息
BC Children's Hospital Research Institute, School of Population and Public Health, University of British Columbia, F508 - 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.
Childhood Obesity Foundation, Robert HN Ho Research Centre, 771A - 2635 Laurel Street, VGH Hospital Campus, Vancouver, BC, V5 1M9, Canada.
出版信息
Trials. 2020 Feb 3;21(1):132. doi: 10.1186/s13063-020-4080-2.
BACKGROUND
The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyle behaviors (e.g., diet, physical activity, and sedentary behaviors). These programs are costly to operate, have limited success, and report recruitment and retention challenges. With recent advances in technology, mobile health or mHealth has been presented as a viable alternative to in-person interventions for behavior change, especially with teens.
PURPOSE
The primary aim of this study is to test the efficacy of Aim2Be, a gamified app based on behavior change theory with health coaching to improve weight outcomes (i.e., decrease in standardized body mass index (zBMI)) and lifestyle behaviors (i.e., improve dietary quality, increase fruit and vegetable intake, reduce sugar-sweetened beverage intake, increase physical activity, and reduce screen time) among children 10- to 17-years old with overweight or obesity versus their peers randomized into a waitlist control condition. The secondary aims of this study are to 1) test whether supplementing the Aim2Be program with health coaching increases adherence and 2) examine the mediators and moderators of adherence to the Aim2Be intervention.
METHODS
We will employ a randomized controlled trial design and recruit 200 child and parent dyads to participate in the study (2019-2020). Participants will be recruited from Canadian pediatric weight management clinics and through online advertisements. Child participants must be between the ages of 10 and 17 years, have overweight or obesity, be able to read English at least at a grade 5 level, and have a mobile phone or home computer with internet access. Following baseline data collection, participants will be randomized into intervention and waitlist control groups. Intervention participants will receive access to Aim2Be, with access to health coaching. After having their data collected for 3 months, the control group will gain access to Aim2Be, with no access to health coaching. Participants will control their frequency and duration of app usage to promote autonomy.
DISCUSSION
Findings from this study will determine the efficacy of using Aim2Be in improving child weight outcomes and lifestyle behaviors and guide future mHealth interventions for pediatric weight management.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03651284. Registered 29 August 2018.
背景
超重和肥胖在加拿大仍然很普遍,目前治疗儿童肥胖的标准是面对面的、以家庭为基础的、多学科的干预措施,针对生活方式行为(如饮食、身体活动和久坐行为)。这些项目运营成本高,成功率有限,并报告了招募和保留方面的挑战。随着最近技术的进步,移动健康或 mHealth 已被提出作为改变行为的一种可行的替代方法,特别是针对青少年。
目的
本研究的主要目的是测试 Aim2Be 的疗效,Aim2Be 是一种基于行为改变理论的游戏化应用程序,结合健康指导,以改善体重结果(即标准化体重指数(zBMI)降低)和生活方式行为(即改善饮食质量、增加水果和蔬菜摄入量、减少含糖饮料摄入量、增加身体活动和减少屏幕时间),与随机分配到候补名单对照组的同龄人相比,10 至 17 岁超重或肥胖的儿童。本研究的次要目的是:1)测试在 Aim2Be 计划中补充健康指导是否会增加依从性,以及 2)研究对 Aim2Be 干预的依从性的中介和调节因素。
方法
我们将采用随机对照试验设计,招募 200 对儿童及其父母参与研究(2019-2020 年)。参与者将从加拿大儿科体重管理诊所和在线广告中招募。儿童参与者必须在 10 至 17 岁之间,至少能够阅读英语五年级水平的文章,并且拥有一部带有互联网接入功能的手机或家用电脑。在基线数据收集后,参与者将被随机分配到干预组和候补名单对照组。干预组参与者将获得访问 Aim2Be 的权限,并获得健康指导。在接受 3 个月的数据收集后,对照组将获得访问 Aim2Be 的权限,但没有健康指导。参与者将控制自己使用应用程序的频率和时长,以促进自主性。
讨论
本研究的结果将确定使用 Aim2Be 改善儿童体重结果和生活方式行为的效果,并指导未来用于儿科体重管理的移动健康干预措施。
试验注册
ClinicalTrials.gov,NCT03651284。于 2018 年 8 月 29 日注册。