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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.0821

摘要内容如下：

重要性

减肥的生活方式干预很难在临床实践中实施。自我管理的移动健康实施，在减肥失败后没有或有额外的支持，可以提供有效的人口水平的肥胖管理。

目的

测试无线反馈系统（WFS）与WFS加电话指导相比是否产生非劣性体重减轻，以及对初始治疗没有反应的参与者是否通过更多或更少的强化干预获得更大的体重减轻。

设计、设置和参与者

在这项非劣效性随机试验中，400名年龄在18岁至60岁之间、身体质量指数在27岁至45岁之间的成年人以1:1的比例随机分配，在2017年6月至2021年3月期间在美国学术医学中心接受为期3个月的初始WFS或WFS+指导治疗。达到次优体重减轻的参与者被重新随机分配，接受适度或有力的逐步干预。

干预措施

WFS包括一个Wi-Fi活动跟踪器和一个将数据传输到智能手机应用程序的体重秤，以提供生活方式改变和减肥进展的每日反馈，WFS Plus教练增加了12个每周10至15分钟的支持性教练电话，由学士学位水平的健康促进者提供，查看参与者在仪表板上的自我监测数据。升级干预措施包括通过移动设备屏幕通知（基于应用程序的屏幕警报）发送支持性消息，而不使用或使用辅导或粉状膳食替代品。参与者和工作人员是非盲性的，结果评估者对治疗随机化是盲性的。

主要成果和措施

主要转归是6个月体重变化的组间差异，非劣效性界值定义为体重变化差异-2.5 kg；次要结果包括所有参与者在3个月和12个月时体重变化的组间差异，以及暴露于适度与有力的逐步干预的无应答者在6个月时体重变化的组间差异。

结果

在400名参与者中（平均[SD]年龄，40.5[11.2]岁；305名[76.3%]妇女；81名参与者是黑人，266名是白人；平均[SD]身体质量指数，34.4[4.3]）随机接受WFS（n=199）与WFS加辅导（n=201），6个月时342名参与者（85.5%）的结果数据可用。WFS组六个月体重减轻-2.8 kg（95%CI，-3.5至-2.0），WFS+辅导组参与者六个月体重减轻-4.8 kg（95%CI，-5.5至-4.1）（体重变化差异，-2.0 kg[90%CI，-2.9至-1.1]；P<.001）；90%CI包括-2.5 kg的非劣效性界值。在3个月和12个月时，体重变化差异具有可比性，在6个月时，在无应答者中，逐步治疗没有差异。

结论和相关性

无线反馈系统（Wi-Fi活动跟踪器和通过智能手机应用程序提供每日反馈的量表）并不比增加了指导的相同系统差。需要继续努力确定减肥管理策略，并为不同个体准确选择干预措施，以实现减肥目标。

试用注册

ClinicalTrials.gov标识符：NCT02997943。

英文原文如下：

Abstracts

Importance  Lifestyle interventions for weight loss are difficult to implement in clinical practice. Self-managed mobile health implementations without or with added support after unsuccessful weight loss attempts could offer effective population-level obesity management.

Objective  To test whether a wireless feedback system (WFS) yields noninferior weight loss vs WFS plus telephone coaching and whether participants who do not respond to initial treatment achieve greater weight loss with more vs less vigorous step-up interventions.

Design, Setting, and Participants  In this noninferiority randomized trial, 400 adults aged 18 to 60 years with a body mass index of 27 to 45 were randomized in a 1:1 ratio to undergo 3 months of treatment initially with WFS or WFS plus coaching at a US academic medical center between June 2017 and March 2021. Participants attaining suboptimal weight loss were rerandomized to undergo modest or vigorous step-up intervention.

Interventions  The WFS included a Wi-Fi activity tracker and scale transmitting data to a smartphone app to provide daily feedback on progress in lifestyle change and weight loss, and WFS plus coaching added 12 weekly 10- to 15-minute supportive coaching calls delivered by bachelor's degree-level health promotionists viewing participants' self-monitoring data on a dashboard; step-up interventions included supportive messaging via mobile device screen notifications (app-based screen alerts) without or with coaching or powdered meal replacement. Participants and staff were unblinded and outcome assessors were blinded to treatment randomization.

Main Outcomes and Measures  The primary outcome was the between-group difference in 6-month weight change, with the noninferiority margin defined as a difference in weight change of -2.5 kg; secondary outcomes included between-group differences for all participants in weight change at 3 and 12 months and between-group 6-month weight change difference among nonresponders exposed to modest vs vigorous step-up interventions.

Results  Among 400 participants (mean [SD] age, 40.5 [11.2] years; 305 [76.3%] women; 81 participants were Black and 266 were White; mean [SD] body mass index, 34.4 [4.3]) randomized to undergo WFS (n = 199) vs WFS plus coaching (n = 201), outcome data were available for 342 participants (85.5%) at 6 months. Six-month weight loss was -2.8 kg (95% CI, -3.5 to -2.0) for the WFS group and -4.8 kg (95% CI, -5.5 to -4.1) for participants in the WFS plus coaching group (difference in weight change, -2.0 kg [90% CI, -2.9 to -1.1]; P < .001); the 90% CI included the noninferiority margin of -2.5 kg. Weight change differences were comparable at 3 and 12 months and, among nonresponders, at 6 months, with no difference by step-up therapy.

Conclusions and Relevance  A wireless feedback system (Wi-Fi activity tracker and scale with smartphone app to provide daily feedback) was not noninferior to the same system with added coaching. Continued efforts are needed to identify strategies for weight loss management and to accurately select interventions for different individuals to achieve weight loss goals.

Trial Registration  ClinicalTrials.gov Identifier: NCT02997943.

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