ClinicalTrials.Veeva

Menu

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

F

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Status and phase

Completed
Phase 3

Conditions

Healthy Lifestyle
Cardiovascular Disease

Treatments

Behavioral: Program SI! educational intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01579708
Preschool_PSI!

Details and patient eligibility

About

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.

Enrollment

2,060 patients

Sex

All

Ages

3 to 5 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,060 participants in 2 patient groups

Program SI! educational intervention
Experimental group
Treatment:
Behavioral: Program SI! educational intervention
Control
No Intervention group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems