School-based intervention for improving children's cardiovascular health
Cluster Randomized Trial for the SI! Program Reintervention for Elementary Schools
This study is testing a program in schools to see if it can help elementary school kids in Spain learn healthier habits and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 5 Years to 8 Years |
| Sex | All |
| Sponsor | Foundation for Science, Health and Education, Spain Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06715358 on ClinicalTrials.gov |
What this trial studies
The SI! Program is a multilevel intervention designed to enhance cardiovascular health and promote healthy lifestyles among elementary school children. Schools in the Madrid Region or Catalonia will be randomly assigned to either the intervention group, which receives the SI! Program, or a control group. The program aims to reinforce children's knowledge, attitudes, and habits related to health, with a focus on sustainability of improvements over time. Assessments will be conducted through questionnaires and direct measures to evaluate changes in lifestyle and cardiovascular health indicators.
Who should consider this trial
Good fit: Ideal candidates for this study are children in the 1st grade attending public or charter schools in the Madrid Region or Catalonia.
Not a fit: Children outside of the 1st grade or those attending private schools may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to lasting improvements in cardiovascular health and healthier lifestyle choices among children.
How similar studies have performed: Previous evaluations of the SI! Program have shown positive results in improving children's health knowledge and habits, although sustainability of cardiovascular health improvements remains a challenge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Schools from the Madrid Region or Catalonia. * Public or charter schools * Schools having from 1st to 6th grades and at least one classroom in 1st grade. * Schools having a canteen * Children in the 1st grade. Exclusion Criteria: * None
Where this trial is running
Madrid
- Foundation for Science, Health and Education — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Valentin Fuster — Mount Sinaí Hospital
- Study coordinator: Gloria Santos-Beneit, PhD
- Email: gsantos@fundacionshe.org
- Phone: +34 914 999 255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.