ORIGINAL RESEARCH article
Front. Digit. Health
Sec. Digital Mental Health
Volume 7 - 2025 | doi: 10.3389/fdgth.2025.1671649
This article is part of the Research TopicPublic Health Strategies to Improve Mental Health in the Education Sector: Perspectives and ApplicationsView all 23 articles
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
Provisionally accepted
- 1Exercise, Cardiometabolic Health and Reproduction (EXCAR) Research Group, Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway;, Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway, Trondheim, Norway
- 2Stjordal Kommune, Stjørdal, Norway
- 3UiT Norges arktiske universitet, Tromsø, Norway
- 4Norges teknisk-naturvitenskapelige universitet, Trondheim, Norway
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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.
Keywords: Obesity, Healthy lifestyle, behavioral change, Mental Health, mHealth, DTX
Received: 23 Jul 2025; Accepted: 25 Aug 2025.
Copyright: © 2025 Isaksen Aukan, Melan, Larsen and Salvesen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Marthe Isaksen Aukan, Exercise, Cardiometabolic Health and Reproduction (EXCAR) Research Group, Department of Circulation and Medical Imaging, Norwegian University of Science and Technology (NTNU), Trondheim, Norway;, Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway, Trondheim, Norway
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