Overview

This trial is active, not recruiting.

Conditions healthy lifestyle, cardiovascular disease
Treatment program si! educational intervention
Phase phase 3
Sponsor Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Start date September 2011
End date June 2012
Trial size 2060 participants
Trial identifier NCT01579708, Preschool_PSI!

Summary

Cardiovascular disease continues to be the principal cause of death in the world. At present, the risk factors for cardiovascular disease continue to appear at an earlier age permitting prevention activities and the promotion of healthy habits to focus on children. Numerous studies have shown that these factors can be controlled in children through school-based interventions. At the same time, data shows that there is a persistence of unhealthy lifestyles (ie sedentary lifestyles, the use of tobacco, etc…) that begin in childhood and are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should begin as early as possible. The SI Program for Preschool Education is an intervention that is both school and home based designed to improve the habits, knowledge and attitudes in four key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This intervention will be implemented in children from three to five years of age, in their parents and in their teachers. To evaluate the efficacy of this intervention, the principal aim of the phase of evaluations is to quantify the behavior changes in the three groups/populations mentioned. The evaluation has been designed according to the controlled intervention model, in which twenty-four schools from the Community of Madrid will be randomized to implement the Program si! for Preschool Education or to function as control schools.

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)
program si! educational intervention
School-based educational program to improve the knowledge, the attitudes, and the habits of children, their parents and teachers, with respect to a healthy lifestyle behavior.
(No Intervention)
program si! educational intervention
School-based educational program to improve the knowledge, the attitudes, and the habits of children, their parents and teachers, with respect to a healthy lifestyle behavior.

Primary Outcomes

Measure
1-year, and 3-year changes from baseline in questionaires scores for knowledge, attitudes, and habits of children, parents and teachers in regards to a healthy lifestyle.
time frame: 3 years

Secondary Outcomes

Measure
1-year, and 3-year changes from baseline in body composition, and blood pressure of children.
time frame: 3 years

Eligibility Criteria

Male or female participants from 3 years up to 5 years old.

Inclusion Criteria: - The schools must be located within the municipality of Madrid - The schools must be public - The schools must have, at the least, two classes for Preschool Education, for children 3, 4 and 5 years of age - The schools must make available the use of the cafeteria. Exclusion Criteria: - NA

Additional Information

Official title Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Principal investigator Jose L Penalvo, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III.