ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01579708
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01579708
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Lifestyle Cardiovascular Disease Behavioral: Program SI! educational intervention Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2060 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 1-year, and 3-year changes from baseline in body composition, and blood pressure of children. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Rodrigo Fernandez-Jimenez, MD PhD Fundacion Centro Nacional de Investigaciones Cardiovasculares
Study Chair: Valentin Fuster, MD, PhD Fundacion Centro Nacional de Investigaciones Cardiovasculares

Additional Information:
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!
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

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