Beyond weight loss: digital therapeutic for behavioral change and psychological well-being for individuals with overweight and obesity in a primary healthcare setting—A randomized controlled pilot study

Abstract

Objective: Mobile health (mHealth) through digital therapeutics (DTx) offer a promising approach to obesity management. This study evaluated the effectiveness of the Lifeness DTx for obesity care and its effect on anthropometrics, reward-related eating behaviors and quality of life in individuals with overweight and obesity within a community-based healthcare setting. Methods: A 12-week randomized controlled trial was conducted. Adults (BMI ≥ 27 kg/m2, and central obesity) were recruited from municipal Healthy Life Centers in Norway. The intervention group (IG) received standard care plus full DTx app with program functionality and digital follow-up, whereas the control group (CG) received standard care with limited app functions and no DTx program. Outcome variables were measured at baseline and after 12 weeks. Results: No significant changes in body weight, or differences between groups were observed at W12. The IG showed reductions in waist circumference (−3.4 cm, p = 0.008, d = −0.926), waist-to-height ratio (−0.02, p = 0.008, d = −0.929), improvements on hedonic eating behavior, indicated by reduced disinhibition (−1.6, p = 0.013, d = −0.907), as well as increased quality of life (+5.0, p = 0.019, d = 0.899). Both groups increased self-esteem (IG +9.8, p = 0.018, d = 0.911, and CG +12, p = 0.050, d = 0.838). Conclusion: The DTx intervention was associated with improvements in central adiposity, reward-related eating behaviors, and psychological well-being beyond weight loss. These findings provide preliminary evidence that digital therapeutics may represent a feasible and scalable approach to support personalized obesity care in primary healthcare settings. Larger, adequately powered trials are needed to confirm these results. Clinical Trial Registration: clinicaltrials.gov, identifier NCT06667843 (Initial Release: 10/15/2024).