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+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+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+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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Introduction: Dietary modification is key to standard behavioral treatment for weight loss. However, few studies assess whether diet quality—the overall healthfulness of the diet—is improved over the course of the intervention. As diet quality is relevant to health separate from its effect on weight, it may be an important endpoint to assess. The purpose of this secondary analysis of a randomized mobile health weight loss trial was to assess whether self-monitoring with automated, personalized feedback (SM+FB) compared to self-monitoring alone (SM) resulted in improved diet quality. Methods: Adults (N=502) with overweight/obesity (n=251 in SM+FB; n=251 SM) were provided calorie, fat gram, and physical activity goals and instructed to weigh daily, wear a Fitbit activity tracker, and self-monitor diet. Feedback messages were sent up to three times daily to SM+FB participants and were based on participant reported intake of calories, fat, and sugar but did not specifically target diet quality. Diet data were collected from two dietary recalls at baseline, 6 months, and 12 months using the Automated Self-Administered system (ASA-24). The Simple Scoring method was used to calculate Healthy Eating Index 2015 (HEI-2015) total scores as it aligns with the Dietary Guidelines for Americans. Change in diet quality was assessed using two-way repeated measures analysis of variance. Missing dietary data was imputed using last observation carried forward. Analyses used intention to treat. Results: The overall sample was mostly female (79%), white (82.5%), and middle-aged (mean=45.0 years, SD=14.4 years). Baseline HEI-2015 total scores were similar between SM (mean=54.44, SE=0.78) and SM+FB (mean=55.49, SE=0.82) and did not improve for either group over 6 months (SM: mean=55.64, SE=0.77; SM+FB: mean=56.89, SE=0.88) or 12 months (SM: mean=56.21, SE=0.81; SM+FB: mean=56.10, SE=0.88). Group, time, and group by time interaction effects were all non-significant (p>0.003) after Bonferroni adjustment. Discussion: Given that the HEI-2015 total score ranges from 0 to 100 with 74 meeting Healthy People 2020 goals, the diet quality of participants was less than ideal (grade: F) at baseline. The small improvements over time were likely not clinically significant. Future mHealth interventions might consider ways to increase user engagement, customization of additional features beyond feedback, and the addition of more targeted nutritional education in order to improve diet quality.

Background 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. Objective 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 2 . Methods 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). Results 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 2 . 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). Conclusions There were no significant between-...

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