Health promotion intervention to prevent risk factors of chronic diseases: Protocol for a cluster randomized controlled trial among adolescents in school settings of Chandigarh (India).

backgroundChronic diseases like diabetes, cardiovascular diseases and cancers are on the rise. Most of the risk factors of these diseases commence in Adolescence. Therefore, a cluster randomised controlled trial is designed to evaluate the effect of school-based health promotion intervention on the risk factors of chronic diseases. METHODOLOGY: Considering school as a cluster, twelve schools will be randomly selected from the public schools of Chandigarh, a city in India. After baseline assessment, six schools will be randomly allocated to intervention and six to the control arm. Study participants will be students of 8th grade (age 10-16 years), their parents and teachers. A sample of 360 students (12 clusters x 30 students) has been estimated to provide statistically valid inference. The PRECEDE PROCEED Model will be used to develop health promotion interventions to prevent the use of an unbalanced diet, physical inactivity, alcohol, and tobacco. Interventions will be implemented for six-months in the school setting. For students, the intervention will comprise interactive learning sessions of 30 minutes duration per week and physical activity sessions of 30 minutes duration four times every week. Educational sessions will be conducted for parents and teachers for 30 minutes, four times during the intervention period. Primary outcomes will be changes in the prevalence of behavioural risk factors from pre- to post-intervention. Changes in anthropometric, physiological, and biochemical measures will be the secondary outcomes. The difference-in-difference (DID) method will be used to measure the net change in the outcomes. DISCUSSION: It is essential to understand whether health promotion interventions implemented in the school setting simultaneously targeting adolescents, teachers, and parents are effective. Using the PRECEDE-PROCEED model for planning, implementing, and evaluating the intervention as part of a cluster Randomized Controlled Trial design with DID analysis, could objectively assess the impact.