Salud Integral Colombia

Not Applicable

Completed

• Conditions: Cardiovascular Health
• Interventions: Other: Control; Other: Education Intervention

• Registration Number: NCT03119792
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Cardiovascular disease (CVD) is a leading cause of mortality worldwide. Negative health behaviors initiated in childhood that persist through adulthood can be risk factors that predict CVD. In Colombia, poor lifestyle factors affecting childhood are very prevalent: 50% live a sedentary lifestyle, 48% have high fat and carbohydrate consumption, 30% are exposed to passive smoking, 14% are overweight or obese, 15.8% have hypercholesteremia, and 5% have hypertension.

Negative health behaviors initiated in childhood that persist through adulthood can be risk factors that predict CVD. In Colombia, poor lifestyle factors affecting childhood are very prevalent: 50% live a sedentary lifestyle, 48% have high fat and carbohydrate consumption, 30% are exposed to passive smoking, 14% are overweight or obese, 15.8% have hypercholesterolemia, and 5% have hypertension. In May 2009, in Bogota, Colombia, was conducted a cluster randomized trial (kindergartens) in 1216 children between 3 and 6 years old, and 928 parents with the aim of evaluate a five months educational intervention to change knowledge, attitudes and habits related to a healthy diet and active lifestyle in preschoolers. The results showed that the intervention was feasible and effective . Finally every 1216 children "cohort Usaquén" received the intervention, performing a follow-up at 18 and 36 months showing that the changes persisted over time

In 2016 the SI! Program will perform a new follow up of this cohort, in children between 9 and 13 years old, and under the assumption that the effects of this intervention have decreased, the researchers plan to evaluate through a randomized control trial the impact of a four months community educational intervention, in the cardiovascular health of these children and in knowledge, attitudes, habits and emotions towards a healthy lifestyle. The study will include children from the Usaquen´s cohort who are contacted and children of a comparable cohort (n = 1200), in order to achieve sustainable changes in the cardiovascular health of children, that impact the burden of disease in their adulthood.

Due to the high rate of migration within the country, given the social and economic difficulties faced by many Colombians, in 2015 the study population was scattered from 1 to 15 localities and from 14 kindergartens to more than 200 public and private schools, mostly in the Usaquen´s locality, with great variability ranging from the facilities, resources, length of the school day, number of children in each classroom, to the training of teachers and their low motivation and availability time to perform any initiative (data obtained from focus groups conducted in schools). For these reasons, it is not feasible to carry out a second educational intervention in schools. However, the investigators believe that a community-based intervention is an excellent choice for tracking this population.

The objective of this project is two-fold. First, it is to assess differences at baseline in healthy lifestyles between children from Usaquen's cohort and a comparable cohort. The study will also assess differences at baseline in cardiovascular health between parents from Usaquen's cohort, and a comparable cohort. Second, it is to assess the impact of a community pedagogical intervention in healthy lifestyles in children nine to thirteen years old.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-19
• Primary Completion: 2018-02-13
• Study Completion: 2018-02-13
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1216

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	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.
Investigational	Education Intervention	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.

Primary Outcome Measures

Name	Time	Method
Change in Ideal Cardiovascular Health Score (ICH)	Baseline and 6 months	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.
Change in KAH score in Children of the Original and Comparable Cohort	Baseline and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in KAH score in Children of the Usaquen Cohort and Comparable Cohort	Baseline and 6 months	Mean and standard deviation of the score of knowledge, attitudes, habits and emotions towards a healthy lifestyle will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened children in the Usaquen´s cohort and intervened children in the comparable cohort. Multivariable models will be performed to adjust for potential confounders. Possible differences between changes in means will be assessed using a t-test.
Change in ICH score in Children of the Original and Comparable Cohort	Baseline and 6 months	Mean difference in scores and standard deviations in cardiovascular health (ICH) at the end of the study between intervened children in the Usaquen´s cohort and intervened children in the comparable cohort, will be determined, using a t-test. Multivariable models will be performed to adjust for potential confounders. The prevalence (CI 95%) of each of the 7 components of cardiovascular health rated as poor (risk factor) will be determined, calculating the difference found between the baseline measurement and the measurement at the end of the study in intervened children in the Usaquen´s cohort and intervened children in the comparable cohort. Possible differences between changes in prevalences will be evaluated using the chi-squared test.
Change in ICH score in Parents of the Original and Comparable Cohort	Baseline and 6 months	In parents, mean difference in scores and standard deviations in cardiovascular health (ICH) at the end of the study between intervened and control groups will be determined, using a t-test, differentiating between parents in the Usaquén´s cohort and a comparable cohort. Multivariable models will be performed to adjust for potential confounders. The prevalence (CI 95%) of each of the 7 components of cardiovascular health rated as poor (risk factor) 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 differentiating between parents in the Usaquén´s cohort and a comparable cohort. Possible differences between changes in prevalences will be evaluated using the chi-square test.

Trial Locations

Locations (1)

Fundacion Cardioinfantil Instituto de Cardiologia; 🇨🇴 Bogota, Colombia