ImportanceLifestyle 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.ObjectiveTo 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 ParticipantsIn 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.InterventionsThe 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 MeasuresThe 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.ResultsAmong 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 RelevanceA 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 RegistrationClinicalTrials.gov Identifier: NCT02997943

中文翻译：

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减肥管理的适应性行为干预

重要性通过生活方式干预减肥很难在临床实践中实施。在减肥尝试失败后，在没有或有额外支持的情况下实施自我管理的移动健康可以提供有效的人口水平肥胖管理。目的测试无线反馈系统（WFS）与 WFS 加电话辅导相比是否能产生不劣质的减肥效果，以及参与者是否没有效果对初始治疗有反应 通过更多或更少强度的逐步干预实现更大的体重减轻。 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 至 60 岁、体重指数为 27 至 45 的成年人被随机分为 1 组。 2017 年 6 月至 2021 年 3 月期间，在美国学术医疗中心接受为期 3 个月的 WFS 治疗或 WFS 加辅导的比例为 1:1。体重减轻效果不佳的参与者被重新随机分组，接受适度或剧烈的逐步干预。 Wi-Fi 活动跟踪器和体重秤将数据传输到智能手机应用程序，以提供有关生活方式改变和减肥进展的每日反馈，WFS plus 辅导增加了由学士学位级别的健康促进人员提供的 12 次每周 10 至 15 分钟的支持性辅导电话在仪表板上查看参与者的自我监控数据；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）提供支持性信息，无论是否有指导或代餐粉。参与者和工作人员均不设盲，结果评估人员对治疗随机化不知情。 主要结果和测量 主要结果是 6 个月体重变化的组间差异，非劣效性界限定义为体重变化差异为 -2.5 kg；次要结果包括所有参与者 3 个月和 12 个月时体重变化的组间差异，以及接受适度与剧烈逐步干预的无反应者之间 6 个月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 [76.3%] 女性；81 名参与者是黑人，266 名参与者是白人；平均 [SD] 体重指数，34.4 [4.3]）随机接受 WFS（n = 199）与 WFS 加辅导（n） = 201），342 名参与者 (85.5%) 在 6 个月时获得了结果数据。 WFS 组的六个月体重减轻为 -2.8 公斤（95% CI，-3.5 至 -2.0），WFS 加辅导组的参与者为 -4.8 公斤（95% CI，-5.5 至 -4.1）（差异体重变化，−2.0 kg [90% CI，−2.9 至 –1.1]；磷< .001); 90% CI 包括-2.5 kg 的非劣效性界限。 3 个月和 12 个月时的体重变化差异相当，无反应者在 6 个月时的体重变化差异相当，通过升级治疗没有差异。结论和相关性无线反馈系统（Wi-Fi 活动跟踪器和带有智能手机应用程序的秤，提供每日反馈）并不逊色于带有额外指导的相同系统。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。试验注册ClinicalTrials.gov 标识符：NCT02997943