CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,770 enrolled
Drug / intervention
PSIE13 +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02428634
NCT02428634N/ACompleted
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The Program SI! for Cardiovascular Health Promotion for Elementary Students Aged 6 to 11: a Cluster Randomized Trial

Foundation for Science, Health and Education, Spain·interventional·Posted Apr 29, 2015·Updated Feb 2, 2021

In Brief

A clinical study evaluating PSIE13 and PSIE46 for Cardiovascular Disease. Completed, enrolled 1,770 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disease
CountriesSpain
CollaboratorsFondation Daniel & Nina Carasso

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 29, 2015
Enrollment StartOct 1, 2014
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 11.2 years ago

Interventions

PSIE13behavioral

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.

PSIE46behavioral

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.