Impact of a Pedagogical Intervention on Children Cardiovascular Risk Factors

NCT ID: NCT03579810

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 870 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Cardiovascular Health

Study Design

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

Study Groups

Investigational

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).

Group Type: EXPERIMENTAL

Investigational

Intervention Type: 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

Control

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

Investigational

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

Intervention Type: OTHER

Control

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.

Intervention Type: OTHER

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%.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role: collaborator

Fundación Cardioinfantil Instituto de Cardiología

OTHER

Sponsor Role: lead

Responsible Party

CespedesJ_PI

Head of the Pediatric Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaime Cespedes, MD

Role: PRINCIPAL_INVESTIGATOR

Fundación Cardioinfantil Instituto de Cardiología

Locations

Fundacion Cardioinfantil Instituto de Cardiologia

Bogotá, Bogota D.C., Colombia

Countries

Colombia

References

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.

Reference Type: RESULT

PMID: 23062403 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34555181 (View on PubMed)

Other Identifiers

IM-564-2012

Identifier Type: -

Identifier Source: org_study_id