Salud Integral Colombia

NCT03119792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1216

Last updated 2019-03-25

No results posted yet for this study

Summary

In May 2009 in Bogota, Colombia, the Si! program conducted a cluster randomized trial in 1216 children between the ages of 3 and 6 years old, and 928 parents with the aim of evaluating a five month education intervention to change knowledge, attitudes and habits related to a healthy diet and active lifestyle in preschoolers. The results showed that the program was feasible and effective. The Si! Program will perform a new follow up of its original children cohort, now between the ages of 9 and 13 years. The original cohort will be compared to a new comparable cohort to assess baseline knowledge, attitudes and habits of healthy lifestyles in knowledge, attitudes, habits and emotions towards a healthy lifestyles . A community pedagogical intervention in healthy lifestyles on cardiovascular health will be implemented in the intervention group.

Conditions

  • Cardiovascular Health

Interventions

OTHER

Education Intervention

The education intervention will help increase the children's knowledge of attitudes, and habits of healthy lifestyles. The program will cover self care of the body and heart, emotional management, healthy diet, and physical activity.

OTHER

Control

The control will not receive an education program relating to knowledge, attitudes, nor habits of healthy lifestyles. Instead, these sessions will occur twice a month, and will last an hour and forty-five minutes. The control program is titled "Life's Challenges", which will focus on helping children develop skills necessary for day to day life, is divided into four modules: Person, Family, School, and Environment. There will be four different types of activities used throughout the program including: "Lets Think," "Lets Experiment," "We will finish with...or synthesis," and "Not here."

Sponsors & Collaborators

  • Fundación Cardioinfantil Instituto de Cardiología

    collaborator OTHER
  • Fundación Mario Santo Domingo

    collaborator UNKNOWN
  • Mobilizarte Social

    collaborator UNKNOWN
  • SHE Foundation

    collaborator OTHER
  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Valentin Fuster, MD, PhD · Icahn School of Medicine at Mount Sinai

  • Jorge Baxter, PhD · Mobilizarte Social

  • Jaime Cespedes, MD · Fundación CardioInfantil de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-02-13
Completion
2018-02-13

Countries

  • Colombia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03119792 on ClinicalTrials.gov