Salud Integral Colombia

• ClinicalTrials.gov Identifier: NCT03119792
• Recruitment Status: Completed
• First Posted: April 19, 2017
• Last Update Posted: March 25, 2019
• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Fundación Cardioinfantil Instituto de Cardiología; Fundación Mario Santo Domingo; Mobilizarte Social; SHE Foundation
• Information provided by (Responsible Party): Valentin Fuster, Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Health	Other: Education Intervention; Other: Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Salud Integral Colombia (SI! Colombia II).
• Study Start Date: November 2016
• Actual Primary Completion Date: February 13, 2018
• Actual Study Completion Date: February 13, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Investigational; 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; 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.
Active Comparator: 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.	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."

Outcome Measures

Primary Outcome Measures :

1. Change in Ideal Cardiovascular Health Score (ICH) [ Time Frame: 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.
2. Change in KAH score in Children of the Original and Comparable Cohort [ Time Frame: 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 :

1. Change in ICH score in Children of the Original and Comparable Cohort [ Time Frame: 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.
2. Change in KAH score in Children of the Usaquen Cohort and Comparable Cohort [ Time Frame: 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.
3. Change in ICH score in Parents of the Original and Comparable Cohort [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 13 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

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

Contacts and Locations

Locations

Colombia

Fundacion Cardioinfantil Instituto de Cardiologia

Bogota, Colombia

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Fundación Cardioinfantil Instituto de Cardiología

Fundación Mario Santo Domingo

Mobilizarte Social

SHE Foundation

Investigators

• Principal Investigator: Valentin Fuster, MD, PhD; Icahn School of Medicine at Mount Sinai
• Study Chair: Jorge Baxter, PhD; Mobilizarte Social
• Study Director: Jaime Cespedes, MD; Fundación CardioInfantil de Cardiologia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fernández-Jiménez R, Briceño G, Céspedes J, Vargas S, Guijarro J, Baxter J, Hunn M, Santos-Beneit G, Rodríguez C, Céspedes 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.

• Responsible Party: Valentin Fuster, Mount Sinai Heart Director, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03119792
• Other Study ID Numbers: GCO 16-1354
• First Posted: April 19, 2017
• Last Update Posted: March 25, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Valentin Fuster, Icahn School of Medicine at Mount Sinai:

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