The effect of a digital health physical activity program integrating gamification for obesity management in comparison to the usual care: a randomized controlled trial with ideographic approach

Digital health interventions and gamification hold promise for managing chronic diseases, but evidence comparing their efficacy to usual care is limited. This two-arm parallel randomized controlled trial with embedded N-of-1 analyses assessed whether a digital intervention integrating gamification and telecoaching (Kiplin) outperform a supervised face-to-face adapted physical activity (PA) program (usual care) in obesity management. Patients with obesity and/or T2D (N = 50, Mage = 46.7 years, 74% female) were randomized to either the Kiplin digital intervention or usual care group, and completed a 3-month program with a 6-month follow-up. The primary outcome was the change in daily step count between baseline and the interventions end. Secondary outcomes assessed changes in daily steps, PA, quality of life, body composition, and physical capacities over nine months. Mixed-effects models and generative additive models were conducted to analyze both between- and within-person evolutions in PA. A cost-utility analysis was computed to compare the cost-effectiveness of the programs. Compared to usual care, Kiplin participants showed significant increases in daily steps during the intervention and follow-up periods, with sustained effect sizes. Idiographic analyses revealed variable individual responses, highlighting the need for tailored approaches. No significant differences were observed in secondary clinical outcomes or the cost-utility analysis. This study demonstrates the potential of digital interventions to sustain PA improvements that could offer an alternative to face-to-face programs, but the clinical and economic impacts need to be further evaluated.