Efficacy of a digital health application for weight management in people with obesity: 6-months results from a randomized controlled trial

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 5%) in people with obesity at 6 months. TRIAL REGISTRATION: This study was registered in the German Clinical Trials Register (Registration number: DRKS00033045).