Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial (Preschool_PSI!)
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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 |
- 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 ]
- 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 |
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| Spain | |
| Fundacion Centro Nacional de Investigaciones Cardiovasculares | |
| Madrid, Spain, 28029 | |
| 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
| 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 May 23, 2013