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Obesity Prevention in Schoolchildren (CRECES)

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Mexicano del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle counseling

Control

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

Body mass index
We will evaluate the change in body mass index

Secondary Outcome Measures

Change in vegetal and fruit consumption
We will evaluate the change in frequency of consumption of diverse fruits and vegetables

Full Information

First Posted
January 23, 2014
Last Updated
April 2, 2014
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Secretaria de Salud, Mexico, Secretaría de Educación Pública, México, Universidad Iberoamericana
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1. Study Identification

Unique Protocol Identification Number
NCT02104973
Brief Title
Obesity Prevention in Schoolchildren
Acronym
CRECES
Official Title
Design and Evaluation of a Strategy to Prevent Overweight and Obesity in Schoolchildren in Mexico City
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Secretaria de Salud, Mexico, Secretaría de Educación Pública, México, Universidad Iberoamericana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body mass index
Description
We will evaluate the change in body mass index
Time Frame
0, 12 months
Secondary Outcome Measure Information:
Title
Change in vegetal and fruit consumption
Description
We will evaluate the change in frequency of consumption of diverse fruits and vegetables
Time Frame
0, 12 months
Other Pre-specified Outcome Measures:
Title
Adiposity
Description
We will evaluate the change in percent of fat mass
Time Frame
0, 12 months
Title
Physical activity
Description
We will evaluate the change in the frequency and kinf of physical activity
Time Frame
0, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco A González, Master
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Mexicano del Seguro Social
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

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Obesity Prevention in Schoolchildren

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