Efficacy of a digital health application for weight management in people with obesity: 6-months results from a randomized controlled trial
Abstract
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. 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. 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. This study was registered in the German Clinical Trials Register (Registration number: DRKS00033045).
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 164 participants or records.
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