Registered exergame and serious game trials with Latin American sites: study design and results reporting

Introduction: Reviews of exergame and serious game trials rarely state where the trials took place or how they were registered. This study described the design, population, conditions and outcome definitions of registered trials with Latin American sites and estimated how often their records show prospective registration and posted results. Methods: Cross-sectional analysis of interventional ClinicalTrials.gov records first submitted between 2011 and 2023 with sites in 24 Latin American and Caribbean countries. Wilson 95% confidence intervals and exploratory Fisher exact tests were used. Results: Of 51 records, 40 were eligible (31 exergame and 9 serious game trials). Brazil hosted 33 trials, 82.5% were randomized, and the median sample size was 48.5. Registration preceded or matched the study start month in 45.0% of trials (95% CI 30.7-60.2), and results were posted for 5.0% (95% CI 1.4-16.5). Serious game trials included children more often than exergame trials (78% versus 23%; Fisher exact p = 0.004). Conclusions: Registered trials with Latin American sites were few, small and concentrated in Brazil, and their records offered little information on results. Prospective registration, results posting and linkage of publications would make these trials easier to find, appraise and combine.