Cluster Randomized Trial for the SI! Program Reintervention in Elementary Schools to Improve Cardiovascular Health

What this Trial Is About

This research aims to assess the effect of reintervention with the SI! Program on cardiovascular health in elementary school children aged 7 to 12 years. The SI! Program is a school-based intervention previously tested in preschool children that focuses on improving knowledge, attitudes, and habits related to lifestyle and cardiovascular health. The study compares the impact of a reintervention with the SI! Program to a single late exposure in elementary schools in Spain to help sustain improvements in cardiovascular health over time. The trial involves 50 elementary schools randomized into two groups. One group will implement the SI! Program environment intervention starting from 2nd grade throughout the whole elementary education period (5 years) with two classroom interventions at 2nd and 5th grades. The other group will begin the intervention only at 5th grade (2 years) with a single classroom intervention. The program addresses lifestyle behaviors including sleep, diet, physical activity, and nutritional status. Participants will be evaluated at baseline and after 3, 5, and 6 years using various measurements such as anthropometry, bioimpedance, blood analysis, accelerometers, and questionnaires. The main outcome is the change in the SI!-Child health score after 5 years, which reflects cardiovascular health status. Secondary outcomes include changes in individual components of the score and other cardiovascular indicators like sedentarism, tobacco exposure, adiposity, blood pressure, lipid profile, and blood glucose. The study aims to determine if the reintervention leads to sustained healthier behaviors and cardiovascular health improvements.

The SI! Program Reintervention for Elementary Schools Trial