Abstract
BACKGROUND: Emerging evidence suggests that digital therapies are effective for treating obesity; however, an evidence gap exists regarding the potency of stand-alone digital therapeutics with limited additional support from a health care professional. This randomized controlled trial examined the efficacy of a digital health application for weight management in people with obesity. METHODS: The decentralized digital randomized controlled trial included 164 adults with obesity (BMI 30-45 kg/m²) from Germany who were randomly assigned to either an intervention group (receiving a digital health application for weight management for 6 months) or a control group (receiving care as usual for 6 months). Data on weight (primary endpoint at 6 months), quality of life (WHOQOL-BREF), and food literacy (SFLQ) were collected at baseline, 3, and 6 months. RESULTS: Participants (n = 164; 42% female, 58% male) had a mean BMI of 37.82 ± 4.25 kg/m² and a mean age of 45.92 ± 10.66 years. At 6 months, the intervention group achieved a mean weight loss of 5.29% ([95% CI: -6.73% to -3.86%], p < 0.001) compared to 1.76% ([95% CI: -3.10% to -0.42%], p = 0.010) in the control group (estimated marginal mean difference (EMMD): -3.53% [95% CI: -5.16% to -1.91%]; p < 0.001) with a large effect size (d = 0.80, [95% CI: 0.43-1.19]). Compared to controls at 6 months, food literacy (EMMD: 2.77, d = 0.49, p < 0.001) and perceived overall quality of life (EMMD: 0.33, d = 0.40, p = 0.010) improved in the intervention group, though no differences in the four quality of life domains were found. CONCLUSIONS: The digital health application for weight management demonstrated efficacy in achieving weight loss (>5%) in people with obesity at 6 months. TRIAL REGISTRATION: This study was registered in the German Clinical Trials Register (Registration number: DRKS00033045).