Integrated Childhood Activity and Nutrition (ICAN) study: Protocol for a randomized controlled trial to prevent...

Children from communities affected by poverty face disproportionate risks of summer learning loss, physical inactivity, and poor diet, contributing to widening disparities in academic and health outcomes. These inequities are further compounded by limited access to high-quality foods and structured opportunities for physical activity during the summer months. Lutein, a xanthophyll carotenoid that accumulates in neural tissue, has been associated with cognitive and visual function. Physical activity and social-emotional learning (SEL) interventions independently improve executive function, self-regulation, and academic readiness. The Integrated Childhood Activity and Nutrition (ICAN) clinical trial (ClinicalTrials.gov: NCT07011602) is a randomized controlled trial evaluating an 8-week summer program integrating daily physical activity, nutrition education, SEL instruction, and lutein-rich foods for elementary-aged children.

Children (aged 6-11 years) eligible for the Supplemental Nutrition Assistance Program will be randomized to an intervention group (Illinois Physical Activity and Life Skills program) or waitlist control. Primary outcomes include academic achievement, behavioral and neuroelectric measures of cognitive functioning, carotenoid status, physical activity, and physical fitness. Secondary outcomes include dietary intake, plate waste, growth, body composition, and nutrition- and SEL-literacy.

We hypothesize that intervention participants will maintain or improve academic and cognitive performance, show greater increases in carotenoid status and fitness, and exhibit gains in SEL and nutrition literacy versus controls.

The ICAN clinical trial will provide evidence on the efficacy of an SEL-framed multicomponent intervention to mitigate summer learning loss, promote healthy behaviors, and support child health and development.