NCT01579708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,060

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

April 16, 2012

Last Update Submit

December 20, 2017

Conditions

Healthy LifestyleCardiovascular Disease

Keywords

DietPhysical activityKnowledgeAttitudesHabitsLifestyleSchool-based

Outcome Measures

Primary Outcomes (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.

    3 years

Secondary Outcomes (1)

  • 1-year, and 3-year changes from baseline in body composition, and blood pressure of children.

    3 years

Study Arms (2)

Program SI! educational intervention

EXPERIMENTAL
Behavioral: Program SI! educational intervention

Control

NO INTERVENTION

Interventions

Program SI! educational interventionBEHAVIORAL

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.

Program SI! educational intervention

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Centro Nacional de Investigaciones Cardiovasculares

Madrid, 28029, Spain

Location

Related Publications (3)

  • 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.

    PMID: 26429075DERIVED

  • 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.

    PMID: 24359285DERIVED

  • 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.

    PMID: 23855415DERIVED

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesMotor ActivityBehaviorHabits

Study Officials

  • Rodrigo Fernandez-Jimenez, MD PhD

    Fundacion Centro Nacional de Investigaciones Cardiovasculares

    PRINCIPAL INVESTIGATOR

  • Valentin Fuster, MD, PhD

    Fundacion Centro Nacional de Investigaciones Cardiovasculares

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 18, 2012

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2014

Last Updated

December 21, 2017

Record last verified: 2017-12

Locations

ES(1)