Obesity Prevention in Schoolchildren

Obesity Clinical Trial

— CRECES  

Official title:

Design and Evaluation of a Strategy to Prevent Overweight and Obesity in Schoolchildren in Mexico City

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02104973
• Other study ID #: 2007-785-060
• Secondary ID: 2007-01-68854
• Status: Active, not recruiting
• Phase: N/A
• First received: January 23, 2014
• Last updated: April 2, 2014
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: January 2014
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: February 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Mexico	Distrito Federal

Sponsors (4)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Secretaría de Educación Pública, México, Secretaria de Salud, Mexico, Universidad Iberoamericana

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adiposity	We will evaluate the change in percent of fat mass	0, 12 months	No
Other	Physical activity	We will evaluate the change in the frequency and kinf of physical activity	0, 12 months	No
Primary	Body mass index	We will evaluate the change in body mass index	0, 12 months	No
Secondary	Change in vegetal and fruit consumption	We will evaluate the change in frequency of consumption of diverse fruits and vegetables	0, 12 months	No