Clinical trial NCT03119792: Salud Integral Colombia
Official title: Salud Integral Colombia (SI! Colombia II).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Health
Keywords: Behavioral Modification
Health Community
Community Intervention
Prevention
Cardiovascular Health
Education Intervention
Colombia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Fundación Cardioinfantil Instituto de Cardiología
name: Fundación Mario Santo Domingo
name: Mobilizarte Social
name: SHE Foundation
First posted: 2017-04-19
Enrollment: 1216
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Ideal Cardiovascular Health Score (ICH)
timeFrame: Baseline and 6 months
measure: Change in KAH score in Children of the Original and Comparable Cohort
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in ICH score in Children of the Original and Comparable Cohort
timeFrame: Baseline and 6 months
measure: Change in KAH score in Children of the Usaquen Cohort and Comparable Cohort
timeFrame: Baseline and 6 months
measure: Change in ICH score in Parents of the Original and Comparable Cohort
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil Instituto de Cardiologia
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Valentin Fuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mobilizarte Social
name: Jorge Baxter, PhD
role: STUDY_CHAIR
affiliation: Fundación CardioInfantil de Cardiologia
name: Jaime Cespedes, MD
role: STUDY_DIRECTOR
References:
citation: 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.