Promoting healthy behaviours in young people with intellectual disabilities: a pilot RCT of an mHealth-based...

Introduction and Purpose: Young individuals with intellectual disabilities (ID) often exhibit low levels of physical activity and high sedentary behaviour, increasing their risk of chronic health conditions. Digital health interventions may offer promising alternatives, although evidence in this population remains limited. This pilot randomised controlled trial (RCT) examined the effectiveness of a gamified mobile health (mHealth) intervention (IDHEApp) in promoting physical activity and reducing sedentary behaviour among youth with ID. Methods: 38 participants with ID (mean age = 20.4 years) were recruited in Rome (Italy) and Rijeka (Croatia) and randomised to an 8-week mHealth intervention or a control condition. Physical activity and sedentary behaviour were assessed using Fitbit Charge 6 devices. The intervention delivered daily gamified activity challenges and feedback tailored to users' cognitive needs. Effects were analysed using ANCOVA with post-intervention values as outcomes and baseline values as covariates, using complete-case analyses. Results: A significant between-group effect was observed for daily step count in favour of the intervention group (adjusted mean difference = 2,326.72 steps/day, 95% CI:763.97 to 3,461.23; p = 0.001; d = 0.97). No significant between-group effects were found for light, moderate, or vigorous physical activity, or for sitting and standing time; these outcomes were considered exploratory. Interaction analyses did not reveal differential effects between participants with Down syndrome and those with other forms of ID. Conclusion: This pilot RCT suggests that a gamified mHealth intervention is feasible and may increase daily ambulatory activity in young people with ID. Although effects were limited to step count, the findings provide hypothesis-generating evidence to inform future adequately powered trials in this underserved population.