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The Program SI! for Cardiovascular Health Promotion at Elementary School

NCT02428634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1770

Last updated 2021-02-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fondation Daniel & Nina Carasso

    collaborator UNKNOWN

  • Foundation for Science, Health and Education, Spain

    lead OTHER

Principal Investigators

  • Valentín Fuster, MD, PhD · Chairman of the Foundation for Science, Health and Education

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428634 on ClinicalTrials.gov