Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatments psie13, psie46
Sponsor Foundation for Science, Health and Education, Spain
Collaborator Fondation Daniel & Nina Carasso
Start date September 2014
End date June 2020
Trial size 2238 participants
Trial identifier NCT02428634, SHE-002-SI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. The intervention is implemented during all the elementary levels (PSIE13+PSIE46).
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.
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.
(No Intervention)
The schools on the control group keep their normal curriculum and don't join any school program about health until the end of the study.
(Experimental)
The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the first three levels (PSIE13).
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.
(Experimental)
The core intervention comprises classroom activities grouped in healthy challenges (about diet, physical activity, human body and heart, and emotions management) distributed across the different levels and implemented by the corresponding teachers. All the materials, formal training and a teaching guide are provided to the school staff by the SHE Foundation. Families receive family-challenges and key messages about their children's health. The school environment is intervened mainly through an annual Healthy Fair. To evaluate the effects of different exposures to the program, the intervention is implemented in the last three levels (PSIE46).
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.

Primary Outcomes

Measure
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to 3-year and 6-year intervention for children.
time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for children
Cardiovascular health markers (blood pressure, height, weight, waist circumference and triceps and subscapular skinfold thickness) of children from baseline to 3-year and 6-year intervention.
time frame: 3-year, and 6-year changes from baseline on cardiovascular health markers of children

Secondary Outcomes

Measure
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for families.
time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for families
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for teachers
time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for teachers
Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for school environment
time frame: 3-year, and 6-year changes from baseline of questionnaire scoring for school environment

Eligibility Criteria

Male or female participants from 5 years up to 6 years old.

Inclusion Criteria: - Children from public schools with canteen services located in the South Madrid Area of Education, having from 1st to 6th grades and at least two classrooms in 1st grade. Exclusion Criteria: - The coordination team of the SHE Foundation establishes the adherence criteria and the schools not reaching the minimum considered can be excluded. Questionnaires scoring from students with special educational needs will be excluded from the analysis of questionnaires, as well as repeat students.

Additional Information

Official title The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial
Principal investigator Emilia Gómez-Pardo, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Foundation for Science, Health and Education, Spain.