Salud Integral Colombia

NCT ID: NCT03119792

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-02-13

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.

Conditions

Cardiovascular Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Education Intervention

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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."

Interventions

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.

Intervention Type: 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."

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundación Cardioinfantil Instituto de Cardiología

OTHER

Sponsor Role: collaborator

Fundación Mario Santo Domingo

UNKNOWN

Sponsor Role: collaborator

Mobilizarte Social

UNKNOWN

Sponsor Role: collaborator

SHE Foundation

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Valentin Fuster

Mount Sinai Heart Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valentin Fuster, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Jorge Baxter, PhD

Role: STUDY_CHAIR

Mobilizarte Social

Jaime Cespedes, MD

Role: STUDY_DIRECTOR

Fundación CardioInfantil de Cardiologia

Locations

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, , Colombia

Countries

Colombia

References

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.

Reference Type: DERIVED

PMID: 32241373 (View on PubMed)

Other Identifiers

GCO 16-1354

Identifier Type: -

Identifier Source: org_study_id