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

NCT ID: NCT01579708

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Lifestyle Cardiovascular Disease

Keywords

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Diet Physical activity Knowledge Attitudes Habits Lifestyle School-based

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Program SI! educational intervention

Group Type EXPERIMENTAL

Program SI! educational intervention

Intervention Type BEHAVIORAL

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodrigo Fernandez-Jimenez, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Centro Nacional de Investigaciones Cardiovasculares

Valentin Fuster, MD, PhD

Role: STUDY_CHAIR

Fundacion Centro Nacional de Investigaciones Cardiovasculares

Locations

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Fundacion Centro Nacional de Investigaciones Cardiovasculares

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 26429075 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24359285 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23855415 (View on PubMed)

Related Links

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http://www.programasi.org/

Related Info

Other Identifiers

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Preschool_PSI!

Identifier Type: -

Identifier Source: org_study_id