一项为期2.5年的使用Noom Health的体重管理计划：一项随机对照试验的方案
A 2.5-Year Weight Management Program Using Noom Health: Protocol for a Randomized Controlled Trial.
作者信息
Sysko Robyn, Bibeau Jessica, Boyar Allison, Costello Kayla, Michaelides Andreas, Mitchell Ellen Siobhan, Susanin Annabel, Hildebrandt Tom
机构信息
Eating and Weight Disorders Program, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Noom Inc, New York, NY, United States.
出版信息
JMIR Res Protoc. 2022 Aug 12;11(8):e37541. doi: 10.2196/37541.
BACKGROUND
Overweight and obesity are serious public health concerns. As the prevalence of excess weight among individuals continues to increase, there is a parallel need for inexpensive, highly accessible, and evidence-based weight loss programs.
OBJECTIVE
This weight loss trial will aim to examine the efficacy of the Noom weight loss program in comparison to a digital control after a 6-month intervention phase and a 24-month maintenance phase, with assessments continuing for 2 years beyond the intervention (to 30 months-after the baseline). The secondary outcomes include quality of life, psychosocial functioning, sleep quality, physical activity, diet, and health status. This trial will also examine the severity of obesity-related functional impairment, weight loss history, and demographic moderators, along with adherence and self-efficacy as mediators of the outcome.
METHODS
A total of 600 participants were randomized in a parallel-group, controlled trial to either Noom Healthy Weight Program (intervention) or Noom Healthy Weight Control (control) for a 6-month intervention. Both intervention and control groups include diet and exercise recommendations, educational content, daily logging capabilities, and daily weigh-in entries. The Noom Healthy Weight Program also includes a coach support for weight loss. Remote follow-up assessments of eating, physical activity, psychosocial factors, app use data, and weight will be conducted at 1, 4, 6, 12, 18, 24, and 30 months after baseline. Weight is measured at each follow-up point during a Zoom call using the participants' scales.
RESULTS
Enrollment began in March 2021 and the 6-month intervention phase ended in March 2022. Data collection for the final assessment will be completed in March 2024.
CONCLUSIONS
This study tests commercially available digital lifestyle interventions for individuals with overweight and obesity seeking weight loss support. Data obtained from the study will evaluate whether the Noom Healthy Weight Control Program can help individuals overcome weight loss, achieve long-term maintenance, adhere to lifestyle changes, and feature use barriers that are present in other traditional weight loss treatments.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04797169; https://clinicaltrials.gov/ct2/show/NCT04797169.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37541.
背景
超重和肥胖是严重的公共卫生问题。随着个体超重患病率持续上升，对低成本、易于获得且基于证据的减肥计划的需求也相应增加。
目的
这项减肥试验旨在比较Noom减肥计划与数字对照在6个月干预期和24个月维持期后的效果，评估在干预后持续2年（至基线后30个月）。次要结果包括生活质量、心理社会功能、睡眠质量、身体活动、饮食和健康状况。该试验还将研究肥胖相关功能损害的严重程度、减肥史和人口统计学调节因素，以及作为结果中介的依从性和自我效能。
方法
共有600名参与者被随机分配到一项平行组对照试验中，分为Noom健康体重计划（干预组）或Noom健康体重对照（对照组），进行为期6个月的干预。干预组和对照组都包括饮食和运动建议、教育内容、每日记录功能和每日体重记录条目。Noom健康体重计划还包括一名教练提供减肥支持。在基线后1、4、6、12、18、24和30个月对饮食、身体活动、心理社会因素、应用程序使用数据和体重进行远程随访评估。在Zoom通话期间，使用参与者的秤在每个随访点测量体重。
结果
招募工作于2021年3月开始，6个月的干预期于2022年3月结束。最终评估的数据收集将于2024年3月完成。
结论
本研究测试了针对寻求减肥支持的超重和肥胖个体的市售数字生活方式干预措施。从该研究中获得的数据将评估Noom健康体重控制计划是否可以帮助个体克服减肥困难、实现长期维持、坚持生活方式改变，以及克服其他传统减肥治疗中存在的功能使用障碍。
试验注册
ClinicalTrials.gov NCT04797169；https://clinicaltrials.gov/ct2/show/NCT04797169。
国际注册报告识别码（IRRID）：DERR1-10.2196/37541。
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