Obesity Prevention in Schoolchildren

NCT ID: NCT02104973

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-02-28

Brief Summary

The purpose of this study is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of Mexico city.

Detailed Description

In Mexico, obesity is becoming the most public health problem. The increase in body mass is associated with the changes in the alimentary environment, resources for physical activity in a context of poor health literacy of the population and low efficacy of the health system. Schools, as social settings, are a opportunity for obesity prevention.

The study includes three phases: 1) evaluation of training, in which the psychological context in which obesity is generated is evaluated. The evaluation will be performed by collection of qualitative and quantitative information, 2) design a strategy from the information obtained. The intervention will include working sessions with teachers, parents and children, establishment of schools in window counseling in nutrition and physical activity and the secretion of a website to not communicate with the public and Provide information, 3) evaluation of the strategy in a community trial with two groups of schools, one intervention and one control.

Conditions

Overweight; Obesity

Study Design

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

Study Groups

Lifestyle counseling

After obtaining the approval of schools and parents, will be established in schools, units in which individual attention is given to children, parents and teachers that request: the advice is aimed at training users on healthy diet and constant physical activity. Workshops with children, in which selected topics will be discussed based on the analysis of depth interviews with children, parents and teachers, and information on habits and resources gathered through questionnaires will be conducted. The intervention included the provision of information and feedback with the population through a website. The work will include participation in the selection of foods sold in schools.

Group Type: EXPERIMENTAL

Lifestyle counseling

Intervention Type: BEHAVIORAL

We will intent to modify the diet of the children. The intervention is designed to promote the increase the intake of fruits and vegetables and to reduce the high density foods consumption.

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle counseling

We will intent to modify the diet of the children. The intervention is designed to promote the increase the intake of fruits and vegetables and to reduce the high density foods consumption.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children students in selected schools
• Anthropometric diagnostic of normality or overweight
• Informed consent of parents

Exclusion Criteria

• Children with special diet or children with limited motor functioning

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Secretaria de Salud, Mexico

OTHER_GOV

Sponsor Role: collaborator

Secretaría de Educación Pública, México

OTHER_GOV

Sponsor Role: collaborator

Universidad Iberoamericana

OTHER

Sponsor Role: collaborator

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco A González, Master

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

2007-01-68854

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2007-785-060

Identifier Type: -

Identifier Source: org_study_id