Rationale, design and methods of the HEALTHY study physical education intervention component.

The HEALTHY primary prevention trial was designed to reduce risk factors for type 2 diabetes in middle school students. Middle schools at seven centers across the United States participated in the 3-year study. Half of them were randomized to receive a multi-component intervention. The intervention integrated nutrition, physical education (PE) and behavior changes with a communications strategy of promotional and educational materials and activities. The PE intervention component was developed over a series of pilot studies to maximize student participation and the time (in minutes) spent in moderate-to-vigorous physical activity (MVPA), while meeting state-mandated PE guidelines. The goal of the PE intervention component was to achieve > or =150 min of MVPA in PE classes every 10 school days with the expectation that it would provide a direct effect on adiposity and insulin resistance, subsequently reducing the risk of type 2 diabetes in youth. The PE intervention component curriculum used standard lesson plans to provide a comprehensive approach to middle school PE. Equipment and PE teacher assistants were provided for each school. An expert in PE at each center trained the PE teachers and assistants, monitored delivery of the intervention and provided ongoing feedback and guidance.

RCT Entities:   Population Interventions Outcomes