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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov Identifier:
NCT01579708
First received: April 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Healthy Lifestyle
Cardiovascular Disease
Behavioral: Program SI! educational intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial

Further study details as provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1-year, and 3-year changes from baseline in body composition, and blood pressure of children. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 2060
Study Start Date: September 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Program SI! educational 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.
No Intervention: Control 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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579708

Locations
Spain
Fundacion Centro Nacional de Investigaciones Cardiovasculares
Madrid, Spain, 28029
Sponsors and Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Investigators
Principal Investigator: Jose L Penalvo, PhD Fundacion Centro Nacional de Investigaciones Cardiovasculares
Study Chair: Valentin Fuster, MD, PhD Fundacion Centro Nacional de Investigaciones Cardiovasculares
  More Information

Additional Information:
No publications provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov Identifier: NCT01579708     History of Changes
Other Study ID Numbers: Preschool_PSI!
Study First Received: April 16, 2012
Last Updated: April 17, 2012
Health Authority: Spain: Consejeria de Sanidad, Comunidad de Madrid

Keywords provided by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III:
Diet
Physical activity
Knowledge
Attitudes
Habits
Lifestyle
School-based

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014