Salud Integral Colombia

NCT03119792 | Completed

• 1 other identifier: GCO 16-1354
• Study Type: interventional
• Target: 1,216
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Behavioral Modification; Health Community; Community Intervention; Prevention; Cardiovascular Health; Education Intervention; Colombia

Outcome Measures

Primary Outcomes (2)

• Change in Ideal Cardiovascular Health Score (ICH)

  Using the metrics and criteria for individual ideal health factors and behaviors, the ideal cardiovascular health score (ICH) will be calculated for each metric (poor=0, intermediate=1, ideal=2 points; range=0-14 points for all seven metrics) and categorized them into three groups: poor (0-4 points), intermediate (5-9 points), and ideal (10-14 points). Higher values represent a better outcome.

  Baseline and 6 months

• Change in KAH score in Children of the Original and Comparable Cohort

  Mean and standard deviation of the score of knowledge, attitudes, habits and emotions towards a healthy lifestyle in children will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened and control groups in the Original and comparable cohort. Possible differences between changes in means will be assessed using test t-test. Multi-variable models will be performed to adjust for potential con-founders.

  Baseline and 6 months

Secondary Outcomes (3)

• Change in ICH score in Children of the Original and Comparable Cohort

  Baseline and 6 months

• Change in KAH score in Children of the Usaquen Cohort and Comparable Cohort

  Baseline and 6 months

• Change in ICH score in Parents of the Original and Comparable Cohort

  Baseline and 6 months

Study Arms (2)

Investigational

EXPERIMENTAL

An education intervention will be implemented for 600 children from the original cohort (300) and comparable cohort (300) over a four month period at community centers. These sessions will occur twice a month on the weekends. The education intervention will help increase the children's knowledge of attitudes, and habits of healthy lifestyles.

Other: Education Intervention

Control

ACTIVE COMPARATOR

The control group will consist of 600 children from the original cohort (300) and comparable cohort (300). The control group will meet twice a month for four months at community centers. During these sessions, investigators will teach a curriculum that is not related to knowledge, attitudes, and habits towards healthy lifestyles.

Other: Control

Interventions

Education Intervention OTHER

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.

Investigational

Control OTHER

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."

Control

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children 9-13 years old from the original Usaquen's cohort
• Children 9-13 years old who are not included in the original cohort (comparable cohort)
• Parents of participating children

You may not qualify if:

• Participant unable to consent
• Parents of non-participating children
• Siblings of the Original Usaquen cohort's children that do not belong to the original cohort

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Fundación Cardioinfantil Instituto de Cardiología: collaborator
• Fundación Mario Santo Domingo: collaborator
• Mobilizarte Social: collaborator
• SHE Foundation: collaborator

Study Sites (1)

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, Colombia

Location

Related Publications (1)

• Fernandez-Jimenez R, Briceno G, Cespedes J, Vargas S, Guijarro J, Baxter J, Hunn M, Santos-Beneit G, Rodriguez C, Cespedes MP, Bagiella E, Moreno Z, Carvajal I, Fuster V. Sustainability of and Adherence to Preschool Health Promotion Among Children 9 to 13 Years Old. J Am Coll Cardiol. 2020 Apr 7;75(13):1565-1578. doi: 10.1016/j.jacc.2020.01.051.

  PMID: 32241373 DERIVED

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Valentin Fuster, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Jorge Baxter, PhD

  Mobilizarte Social

  STUDY CHAIR

• Jaime Cespedes, MD

  Fundación CardioInfantil de Cardiologia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mount Sinai Heart Director

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 19, 2017
• Study Start: November 1, 2016
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)