Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors

NCT03579810 | Completed DMC

• 1 other identifier: IM-564-2012
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Health

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in active energy expenditure in children

  The energy expenditure (Kilocalories/day), in children from Kindergarten to grade 2 of elementary school, generated by physical activity was evaluated using accelerometers during 4 consecutive days, 24hours/day (2 weekend days and two schooldays) through an Actiheart® 4 type accelerometer. Possible differences between changes in active energy expenditure means was assessed using test t-test. Multi-variable models were performed to adjust for potential con-founders.

  Baseline and 2.5 years

• Changes in healthy foods consumption in children

  A food frequency survey (ENSIN 2010) was used in children from Kindergarten to grade 2 of elementary school. Healthy foods consumptions were defined as the accomplishment of 3-4 of the 4 measured components (intake of Fruits and vegetables ≥3 times a day, Fiber: ≥3 times a day, Fish: ≥2 times a week, Sugary beverages: ≤ 1 time a day). Possible differences between changes in the proportion of children with healthy foods consumption was assessed using chi2 test. Multi-variable models were performed to adjust for potential con-founders.

  Baseline and 2.5 years

Secondary Outcomes (8)

• Changes in the Body Mass Index in children

  Baseline and 2.5 years

• Changes in the perimeter of the waist in children

  Baseline and 2.5 years

• Changes in total cholesterol in children

  Baseline and 2.5 years

• Changes in triglycerides in children

  Baseline and 2.5 years

• Changes in fasting glycemia in children

  Baseline and 2.5 years

Study Arms (2)

Investigational

EXPERIMENTAL

An education intervention was implemented in 5 schools including 516 children, 360 parents and 240 teachers. The Pedagogical Intervention last two and a half years. In children, the intervention included class activities (1/week) and the use of educational materials for the development of pedagogical activities (posters and educative guide). In parents included 3 workshops/year (2 hours each) about the areas of the intervention; sending healthy notes (1/month) and celebration of healthy family day (1/year). In teachers included 3 workshops/year (2 hours each) about the areas of the intervention; planning and realization of pedagogical activities to develop with the students (1/week) and follow-up visits to school (1/month).

Other: Investigational

Control

ACTIVE COMPARATOR

The control group consisted of 4 schools including 354 children, 305 parents and 110 teachers. The activities in control group last two and a half years. Children received the standard curriculum in health and physical activity of the national Ministry of Education. In parents and teachers included 3 workshops/year (2 hours each) about the first aid and accident prevention.

Other: Control

Interventions

Investigational OTHER

The educational intervention helped to increase the knowledge of attitudes, and habits of healthy lifestyle in children, parents and teachers and it was based on health promotion models and social cognitive theory, to be articulated with the Institutional Educational Project through the pedagogical component that integrates three areas, physical activity, healthy eating, and the knowledge of the body and the heart with the dynamics of the educative community. The program covered self-care of the body and heart, healthy diet, and physical activity

Investigational

Control OTHER

The control group did not receive an educational intervention in areas of physical activity, healthy eating, and the knowledge of the body and the heart. Instead, children received the standard curriculum in health and physical activity of the national Ministry of Education.

Control

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Fundación Cardioinfantil Instituto de Cardiología: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator

Study Sites (1)

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, Bogota D.C., Colombia

Location

Related Publications (2)

• 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.

  PMID: 23062403 RESULT

• 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.

  PMID: 34555181 DERIVED

Study Officials

• Jaime Cespedes, MD

  Fundación Cardioinfantil Instituto de Cardiología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Pediatric Service

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: February 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)