The SI! Program Reintervention for Elementary Schools Trial

Not Applicable

Recruiting

• Conditions: Cardiovascular Health; Obesity

• Registration Number: NCT06715358
• Lead Sponsor: Foundation for Science, Health and Education, Spain

Brief Summary

Background and objectives:

The SI! Program is a multilevel school-based intervention that has been previously evaluated in different ages in three countries. Schools were randomized to the SI! Program intervention or the control group, and prior to and after the intervention several questionnaires and direct measures were used to assess changes in lifestyle and cardiovascular health indicators. In the SI! Program for Preschool, children in the intervention group increased significantly more their knowledge, attitudes and habits after 4 months of the implementation of the SI! Program compared to children in the control group. However, until now, results have shown that improvements in cardiovascular health between 3 and 5 years old do not sustain overtime. For this reason, the new project of the SI! Program proposes a reinforcement of the children's environment to boost the effect of the intervention and a reinforcement in the classroom after 2 years to favor the sustainability of the effect. The main objective of this study is to assess the effect of the reintervention of the SI! Program in the SI!-Child health score in Elementary school children (7-12 years old) and compare its effect with a single late exposure to the SI! Program.

Methodology:

A cluster-randomized trial involving 50 elementary schools in Spain will be carried out. Schools will be 1:1 randomized to either implement the SI! Program from 2nd grade throughout the whole Elementary Education (5 years) with two classroom interventions (one at 2nd grade and one at 5th grade) or to implement the SI! Program from 5th grade throughout the rest of the Elementary Education (2 years) with only one classroom intervention at 5th grade. Children in the first year of Elementary education at the beginning of the trial will be recruited. Participants will be evaluated at baseline, and after 3, 5 and 6 years using a battery of measurements on cardiovascular health parameters (anthropometry, bioimpedance, blood analysis, accelerometers, questionnaires). The primary endpoint will be the change in the SI!-Child score after 5 years. The SI! Child score includes sleep, diet, physical activity and nutritional status, and ranges from 0 to 100, with higher scores indicating better cardiovascular profiles. Secondary outcomes include the change in individual components of the SI!-Child score and other cardiovascular health indicators such as sedentarism, tobacco exposure, adiposity, blood pressure, lipid profile and blood glucose, and to assess the effect of the SI! Program reintervention to maintain or improve all cardiovascular health indicators previously mentioned one year after the reintervention.

Expected results:

The investigators expect to show that a school-based educational intervention with a reinforcement in the classroom after 2 years in addition to a school environment intervention will induce favorable and sustainable lifestyle changes in health behaviors among Spanish children. If successful, this strategy could be widely adopted having a meaningful effect on cardiovascular health promotion.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Study First Submitted: 2024-11-19
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2030-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the SI!-Child health score at the end of the intervention	From baseline assessment to the end of the intervention, an average of 5 years	The primary outcome will be the difference in the SI!-Child score (0-100 points for each component, higher scores indicating healthier habits) between the reintervention group and the late intervention group. The SI! Child score includes Sleep (measured as hours of sleep), Diet (fruits and vegetables, sugared beverages, fast-food, legumes and nuts, sweets and pastries), Physical activity (minutes of moderate and vigorous physical activity), Nutritional status (body mass index calculated as body weight divided by height squared (kg/m2).

Secondary Outcome Measures

Name	Time	Method
Effect of the SI! Program reintervention in the individual components of the SI!-Child health score	From baseline assessment to the end of the intervention, an average of 5 years	Mean score and change at follow-up visits for each of the individual components of the SI! Child score (0-100 points for each component, higher scores indicating healthier habits): Sleep (measured as hours of sleep ), Diet (fruits and vegetables, sugared beverages, fast-food, legumes and nuts, sweets and pastries), Physical activity (minutes of moderate and vigorous physical activity), nutritional status (body mass index calculated as body weight divided by height squared (kg/m2)).

Trial Locations

Locations (1)

Foundation for Science, Health and Education; 🇪🇸 Madrid, Spain