Clinical trial NCT03579810: Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors
Official title: Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Health
Keywords: Behavioral Modification
Health Community
Community Intervention
Prevention
Education Intervention
Cardiovascular Health
Colombia
Lead sponsor: Fundación Cardioinfantil Instituto de Cardiología
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2018-07-09
Enrollment: 870
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In Bogotá, Colombia, the Fundación Cadioinfantil performed a randomized and controlled community trial, to evaluate the impact of a pedagogical intervention (PI) on cardiovascular health towards an active lifestyle and healthy eating in 9 schools of the city, including children from kindergarten to second grade of elementary school, their parents and teachers.

Detailed description: Cardiovascular disease (CVD) is a leading cause of mortality worldwide and Colombia is not an exception. Epidemiological studies have demonstrated that CVD risk factors are identifiable in childhood and they are predictor of CDV risk in adulthood. Worldwide, CDV primary prevention that begins in childhood is identified as a strategy that decreases the burden of this disease.

Programs developed in educational communities (EC), that include in their planning and implementation students, teachers and parents, with training to food personnel, are the most effective strategies to create healthy school environments and reduce the burden of chronic diseases. However recent studies that evaluate physical activity through accelerometers have not shown effectiveness.

In 2009, the Si! program and Fundación CardioInfantil performed a randomized and controlled community trial in facilities of the Colombian Family welfare Institute, ICBF, from Usaquen locality in Bogotá, finding that a pedagogical intervention (PI) in preschool children, their parents and teachers is effective in improving knowledge, attitudes and habits towards an active lifestyle and healthy diet.

The construction of the proposed intervention is based on the best available evidence about programs, policies and practices that positively impact in healthy eating and physical activity habits in EC.

The objectives of this project are to evaluate changes in healthy foods consumption and energy expenditure in children from kindergarten to second grade of elementary school that receives pedagogical intervention (PI) adapted to its context, compared to another EC that develops its habitual curriculum. In addition, this study evaluates changes on cardiovascular risk factors in children. Also, it evaluates changes in healthy foods consumption in their parents and teachers.

Eligibility criteria: Inclusion Criteria:

* Private schools located in the urban area of Bogotá
* Schools with an appropriate physical activity space and infrastructure.
* Schools that allow the study conduction.

Exclusion Criteria:

* Schools that have received interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the year prior to the start of the study.
* Schools that plan to receive interventions of more than 1 month in healthy habits (nutrition and / or physical activity) during the time of follow-up of the study.
* Schools with a history of annual dropout of their students or teachers greater than 10%.

Primary outcomes:
measure: Change in active energy expenditure in children
timeFrame: Baseline and 2.5 years
measure: Changes in healthy foods consumption in children
timeFrame: Baseline and 2.5 years
Secondary outcomes:
measure: Changes in the Body Mass Index in children
timeFrame: Baseline and 2.5 years
measure: Changes in the perimeter of the waist in children
timeFrame: Baseline and 2.5 years
measure: Changes in total cholesterol in children
timeFrame: Baseline and 2.5 years
measure: Changes in triglycerides in children
timeFrame: Baseline and 2.5 years
measure: Changes in fasting glycemia in children
timeFrame: Baseline and 2.5 years
measure: Change in blood pressure in children
timeFrame: Baseline and 2.5 years
measure: Changes in the consumption of healthy foods in teachers
timeFrame: Baseline and 2.5 years
measure: Changes in the consumption of healthy foods in parents
timeFrame: Baseline and 2.5 years
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundacion Cardioinfantil Instituto de Cardiologia
state: Bogota
Study officials:
affiliation: Fundación Cardioinfantil Instituto de Cardiología
name: Jaime Cespedes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cespedes J, Briceno G, Farkouh ME, Vedanthan R, Baxter J, Leal M, Boffetta P, Woodward M, Hunn M, Dennis R, Fuster V. Targeting preschool children to promote cardiovascular health: cluster randomized trial. Am J Med. 2013 Jan;126(1):27-35.e3. doi: 10.1016/j.amjmed.2012.04.045. Epub 2012 Oct 9.
citation: Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.