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.