Clinical trial NCT02428634: The Program SI! for Cardiovascular Health Promotion at Elementary School
Official title: The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Cardiovascular health promotion
Children
School intervention
Lead sponsor: Foundation for Science, Health and Education, Spain
Sponsor class: OTHER
Collaborators: name: Fondation Daniel & Nina Carasso
First posted: 2015-04-29
Enrollment: 1770
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

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.
timeFrame: 3-year, and 6-year changes from baseline of questionnaire scoring for children
measure: 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.
timeFrame: 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.
timeFrame: 3-year, and 6-year changes from baseline of questionnaire scoring for families
measure: Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for teachers
timeFrame: 3-year, and 6-year changes from baseline of questionnaire scoring for teachers
measure: Difference between control and intervention groups in the mean change in questionnaire's scoring from baseline to post-intervention for school environment
timeFrame: 3-year, and 6-year changes from baseline of questionnaire scoring for school environment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Foundation for Science, Health and Education
Study officials:
affiliation: Chairman of the Foundation for Science, Health and Education
name: Valentín Fuster, MD, PhD
role: STUDY_CHAIR
References:
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citation: Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.
citation: Santos-Beneit G, Bodega P, de Miguel M, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, de Cos-Gandoy A, Penalvo JL, Gomez-Pardo E, Oliva B, Ibanez B, Fernandez-Alvira JM, Fernandez-Jimenez R, Fuster V. Rationale and design of the SI! Program for health promotion in elementary students aged 6 to 11 years: A cluster randomized trial. Am Heart J. 2019 Apr;210:9-17. doi: 10.1016/j.ahj.2018.12.011. Epub 2019 Jan 8.