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 intervention’s 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.

AM PhD grant was funded by the French National Association for Research and Technology (ANRT) and Kiplin. MB was employed by Kiplin at the time of data collection. AC and MD have been unpaid members of the scientific steering group of the Kiplin company. All other authors declare no other conflicts of interest. The results of this study could be beneficial to Kiplin from a marketing point of view. The Kiplin company had no input in the design of the study and no influence on the interpretation or publication of the study results.

NCT04887077

https://bmjopen.bmj.com/content/12/6/e058015.abstract

This project was funded by a grant of the challenge 3 I-SITE Clermont Auvergne Project 20-25. Trial sponsor: University Hospital CHU G. Montpied, Clermont-Ferrand.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The protocol of this trial has been reviewed and approved by the National Human Protection Committee (CPP Ile de France XI, No 21 004-65219).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

↵* The DOI is available at the top of this page

Cite this article: Mazéas, A., Chalabaev, A., Blond, M., Mourgues, C., Pereira, B., Duclos, M. (2025). 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. MedRxiv.*

Data, code, & materials: DOI 10.17605/OSF.IO/YPD5S

The anonymized data used in this study and the R code are available on the Open Science Framework (DOI 10.17605/OSF.IO/YPD5S).

https://osf.io/ypd5s/