Clinical trial NCT01579708: Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Official title: Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Lifestyle
Cardiovascular Disease
Keywords: Diet
Physical activity
Knowledge
Attitudes
Habits
Lifestyle
School-based
Lead sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 2060
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

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.
timeFrame: 3 years
Secondary outcomes:
measure: 1-year, and 3-year changes from baseline in body composition, and blood pressure of children.
timeFrame: 3 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Centro Nacional de Investigaciones Cardiovasculares
Study officials:
affiliation: Fundacion Centro Nacional de Investigaciones Cardiovasculares
name: Rodrigo Fernandez-Jimenez, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Centro Nacional de Investigaciones Cardiovasculares
name: Valentin Fuster, MD, PhD
role: STUDY_CHAIR
References:
citation: Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Bodega P, Oliva B, Orrit X, Rodriguez C, Fernandez-Alvira JM, Redondo J, Vedanthan R, Bansilal S, Gomez E, Fuster V. The SI! Program for Cardiovascular Health Promotion in Early Childhood: A Cluster-Randomized Trial. J Am Coll Cardiol. 2015 Oct 6;66(14):1525-1534. doi: 10.1016/j.jacc.2015.08.014.
citation: Penalvo JL, Sotos-Prieto M, Santos-Beneit G, Pocock S, Redondo J, Fuster V. The Program SI! intervention for enhancing a healthy lifestyle in preschoolers: first results from a cluster randomized trial. BMC Public Health. 2013 Dec 20;13:1208. doi: 10.1186/1471-2458-13-1208.
citation: Penalvo JL, Santos-Beneit G, Sotos-Prieto M, Martinez R, Rodriguez C, Franco M, Lopez-Romero P, Pocock S, Redondo J, Fuster V. A cluster randomized trial to evaluate the efficacy of a school-based behavioral intervention for health promotion among children aged 3 to 5. BMC Public Health. 2013 Jul 15;13:656. doi: 10.1186/1471-2458-13-656.