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成年初期的行为体重管理:里士满成年初期健康选择(REACH)随机临床试验的设计和原理。

Behavioral weight loss in emerging adults: Design and rationale for the Richmond Emerging Adults Choosing Health (REACH) randomized clinical trial.

机构信息

Virginia Commonwealth University School of Medicine, Department of Health Behavior and Policy, 830 East Main Street, Box 980430, Richmond, VA 23219, United States of America.

University of Connecticut, Department of Allied Health Sciences, Koons Hall, Room 228, 358 Mansfield Road, Unit 1101, Storrs, CT 06269-1101, United States of America.

出版信息

Contemp Clin Trials. 2021 Aug;107:106426. doi: 10.1016/j.cct.2021.106426. Epub 2021 May 24.

DOI:10.1016/j.cct.2021.106426
PMID:34044124
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8559298/
Abstract

BACKGROUND

In the U.S., over 40% of 18-25 year olds meet criteria for overweight or obesity. Yet, no large-scale trials have targeted this age group for behavioral weight loss (BWL). Formative data revealed that existing BWL programs do not meet their unique needs and identified motivation as a fundamental barrier for weight management. The goal of the Richmond Emerging Adults Choosing Health (REACH) trial was to test the efficacy of two mHealth lifestyle interventions specifically focused on enhancing motivation, relative to adapted standard.

METHODS

Participants (N = 381, 18-25 years, body mass index 25-45 kg/m) will be randomized to 1) adapted BWL (aBWL), 2) aBWL + self-determination theory (aBWL+SDT), or 3) aBWL + behavioral economics (aBWL+BE). All arms will receive a 6-month intervention, delivered via one group session and one individual session, followed by an mHealth platform. Assessments will occur at baseline, 3-months, 6-months (post-treatment) and 12-months (following a no-contact period). The primary aim is to compare weight loss outcomes at 6 months. Secondary aims include changes at 6-months in physical and behavioral cardiometabolic risk factors, as well as psychosocial measures. We will also explore weight loss maintenance, change in hypothesized mediators, and moderators of treatment response.

DISCUSSION

REACH is the first large-scale BWL trial designed specifically for emerging adults. Further, it will be the first trial to compare a lifestyle intervention grounded in self-determination theory to one rooted in behavioral economics. If clinically significant reductions in adiposity are achieved, findings could inform a scalable treatment model to meet the needs of this vulnerable population.

TRIAL REGISTRATION

NCT02736981.

摘要

背景

在美国,超过 40%的 18-25 岁年轻人符合超重或肥胖标准。然而,还没有针对这个年龄段的行为减肥(BWL)的大规模试验。形成性数据显示,现有的 BWL 计划无法满足他们的独特需求,并确定动机是体重管理的一个基本障碍。里士满新兴成年人选择健康(REACH)试验的目标是测试两种特定于增强动机的移动健康生活方式干预措施的功效,相对于适应标准。

方法

参与者(N=381,18-25 岁,体重指数 25-45kg/m)将随机分为 1)适应 BWL(aBWL),2)aBWL+自我决定理论(aBWL+SDT)或 3)aBWL+行为经济学(aBWL+BE)。所有组别将接受为期 6 个月的干预,通过一次小组会议和一次个别会议进行,然后使用移动健康平台。评估将在基线、3 个月、6 个月(治疗后)和 12 个月(无接触期后)进行。主要目的是比较 6 个月时的体重减轻结果。次要目标包括 6 个月时身体和行为心血管代谢风险因素以及心理社会措施的变化。我们还将探索减肥维持、假设中介物的变化以及治疗反应的调节因素。

讨论

REACH 是专门为新兴成年人设计的第一个大规模 BWL 试验。此外,它将是第一个比较基于自我决定理论的生活方式干预与基于行为经济学的干预的试验。如果实现了肥胖症的显著减少,研究结果可以为满足这一脆弱人群的需求提供一种可扩展的治疗模式。

试验注册

NCT02736981。

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