OBJECTIVE: This study aimed to test the efficacy of self-monitoring and feedback (SM+FB) versus SM without FB (SM) in a behavioral weight-loss intervention at 6 months. METHODS: This was a randomized clinical trial. Eligibility criteria included the following: >= 18 years of age, BMI >= 27 and <= 43, smartphone user, and ability to engage in moderate physical activity. All participants received a 90-minute 1:1 counseling session, a Fitbit Charge 2, and a digital scale for SM. SM plus FB participants were provided access to a customized smartphone application that provided three daily FB messages. The primary outcome was percentage of weight change from 0 to 6 months. RESULTS: The sample (N = 502) was 45 (SD 14.4) years old, BMI was 33.7 (SD 4.00) kg/m2, 79.5% of participants were female (n = 399), and 84.3% were white (n = 423). At 6 months, there was 85.86% retention and a significant percentage of weight change in both groups (SM plus FB -3.16%, 95% CI -3.85% to -2.47%, p < 0.0001; SM -3.20%, 95% CI -3.86% to -2.54%, p < 0.0001) but no significant between-group mean difference (-0.04%, 95% CI -0.99% to 0.91%, p = 0.940). A >= 5% weight loss was achieved by 31.9% of the SM plus FB group and 28.3% of the SM group. CONCLUSIONS: There was no significant between-group difference in weight loss at 6 months.

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