NCT02428634

The Program SI! for Cardiovascular Health Promotion at Elementary School

The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,770 (actual)
• Sponsor: Foundation for Science, Health and Education, Spain · Academic / Other
• Sex: All
• Age: 5 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers and parents). For this purpose, 48 public schools from the Community of Madrid-South Area (Spain) were randomly assigned to Program SI! during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, their parents and teachers in regards to a healthy lifestyle. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry.

Detailed description

The Program SI! is a multilevel school-based intervention integrating four cardiovascular health-related components (diet, physical activity, human body and emotions management). Since the Program SI! for preschoolers has shown good results in improving healthy lifestyle habits in children aged 3 to 5 years, the investigators have developed the Program SI! for Elementary addressed to children from 6 to 11 years. The objective of the study is to evaluate the effects of Program SI! for Elementary in different times of exposure for childrens and their immediate environment (teachers, parents and school). In the Community of Madrid-South Area (Spain), 48 public schools from were randomly assigned to Program SI! for Elementary during 3 or 6 academic years (intervention group) or keep their normal curriculum (control group). The main outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of children, and the secondary outcome is 3-year, and 6-year changes from baseline of questionnaire scoring of their parents and teachers in regards to a healthy lifestyle, as well as changes in the school environment. For children were included 3-year, and 6-year changes of cardiovascular markers derived from blood pressure and anthropometry (weight, height, waist circumference and skinfold thickness). The Program SI! for Elementary is designed for different exposures in a sample of schools never intervened to asses when the intervention has the most effectiveness. Besides, as some schools involved in the preschool study continues the Program SI! for Elementary, the investigators can be able to evaluate the impact of the Program SI! in different school stages, concluding how children keep the adoption of healthy behaviors from early in life.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
BEHAVIORAL	PSIE13	The Program SI! is implemented from 1st to 3rd grade of Elementary. A total of 40 hours of intervention on 1st and 2nd grade and 30 hours on 3rd grade has been established as the minimum intervention per year.
BEHAVIORAL	PSIE46	The Program SI! is implemented from 4th to 6th grade of Elementary. A total of 30 hours of intervention has been established as the minimum intervention per year.

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2015-04-29
• Last updated: 2021-02-02

Locations

1 site across 1 country: Spain