Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial

Cardiovascular Disease Clinical Trial

— Preschool_PSI!  

Official title:

Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579708
• Other study ID #: Preschool_PSI!
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2012
• Last updated: December 20, 2017
• Start date: September 2011
• Est. completion date: June 2014

Study information

• Verified date: December 2017
• Source: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2060
• Est. completion date: June 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Healthy Lifestyle

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Fundacion Centro Nacional de Investigaciones Cardiovasculares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 years
Secondary	1-year, and 3-year changes from baseline in body composition, and blood pressure of children.		3 years

External Links

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