School of Nursing, University of Pittsburgh, Pittsburgh, PA, United States.
School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.
J Med Internet Res. 2022 Jul 5;24(7):e38243. doi: 10.2196/38243.
Self-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials.
The aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m.
All participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants' dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal).
Participants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: -2.12%, 95% CI -3.04% to -1.21%, P<.001; SM: -2.39%, 95% CI -3.32% to -1.47%; P<.001), but no difference between the groups (-0.27%; 95% CI -1.57% to 1.03%; t =-0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=-0.10; 95% CI -0.13 to -0.07; t =-5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001).
There were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools.
Clinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936.
自我监测（SM）是行为减肥治疗的核心，但是智能手机提供的反馈（FB）的功效尚未在大型、长期、随机试验中得到检验。
本研究的目的是在一项为期 12 个月的随机对照试验中，比较提供饮食、体力活动（PA）和体重 SM 的远程 FB 与仅提供 SM 的条件，确定向 SM 加 FB（SM+FB）条件提供远程 FB 对改善减肥效果的作用。该研究是一项基于人群的单站点试验，在美国宾夕法尼亚州西南部进行，于 2018 年至 2021 年进行。参与者为智能手机用户，年龄≥18 岁，能够进行中度 PA，平均 BMI 介于 27 至 43kg/m²之间。
所有参与者都接受了 90 分钟的一对一、面对面的行为减肥咨询，内容涉及行为策略、确定参与者的饮食和 PA 目标，并指导使用 PA 追踪器（Fitbit Charge 2）、智能秤和饮食 SM 应用程序。只有 SM+FB 参与者可以使用研究人员开发的智能手机应用程序，该应用程序可以读取 SM 数据，其中算法会选择适合的消息，每天最多向智能手机发送 3 次。仅提供 SM 的参与者不会根据 SM 数据收到任何定制化的 FB。主要结局是从基线到 12 个月时的体重百分比变化。次要结局包括对数字工具的使用情况（例如，每月打开 FB 消息的百分比和每月遵守卡路里目标的天数百分比）。
参与者（N=502）的平均年龄为 45.0（SD 14.4）岁，平均 BMI 为 33.7（SD 4.0）kg/m²。该样本中 79.5%（n=399/502）为女性，82.5%（n=414/502）为白人。在 12 个月时，保留率为 78.5%（n=394/502），两组之间相似（SM+FB：202/251，80.5%；SM：192/251，76.5%；P=.28）。两组均有显著的体重百分比减轻（SM+FB：-2.12%，95%CI -3.04%至-1.21%，P<.001；SM：-2.39%，95%CI -3.32%至-1.47%，P<.001），但两组之间没有差异（-0.27%，95%CI -1.57%至 1.03%；t =-0.41；P=.68）。同样，SM+FB 组中有 26.3%（66/251）的人达到了≥5%的体重减轻，SM 组中有 29.1%（73/251）的人达到了这一目标（卡方值=0.49；P=.49）。每月打开的 FB 消息增加 1%，与 12 个月时体重百分比减轻增加 0.10 相关（b=-0.10；95%CI -0.13 至 -0.07；t =-5.90；P<.001）。每月打开的 FB 消息增加 1%，与每天遵守卡路里目标的百分比增加 0.12 相关（b=0.12；95%CI 0.07-0.17；F=22.19；P<.001）。
两组之间的减肥效果没有显著差异；然而，研究结果表明，使用具有或不具有 FB 的商业上可用的数字 SM 工具，超过 25%的参与者的体重减轻了有临床意义的幅度。未来的研究需要测试额外的策略，以促进对数字工具的更多使用。
Clinicaltrials.gov NCT03367936；https://clinicaltrials.gov/ct2/show/NCT03367936.
