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Obesity Prevention in Schoolchildren (CRECES)

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ClinicalTrials.gov Identifier: NCT02104973
Recruitment Status : Unknown
Verified January 2014 by Coordinación de Investigación en Salud, Mexico.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Collaborators:
Secretaria de Salud, Mexico
Secretaría de Educación Pública, México
Universidad Iberoamericana
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Lifestyle counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Design and Evaluation of a Strategy to Prevent Overweight and Obesity in Schoolchildren in Mexico City
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Body mass index [ Time Frame: 0, 12 months ]
    We will evaluate the change in body mass index


Secondary Outcome Measures :
  1. Change in vegetal and fruit consumption [ Time Frame: 0, 12 months ]
    We will evaluate the change in frequency of consumption of diverse fruits and vegetables


Other Outcome Measures:
  1. Adiposity [ Time Frame: 0, 12 months ]
    We will evaluate the change in percent of fat mass

  2. Physical activity [ Time Frame: 0, 12 months ]
    We will evaluate the change in the frequency and kinf of physical activity



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104973


Locations
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Mexico
Instituto Mexicano del Seguro Social
Mexico, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Secretaria de Salud, Mexico
Secretaría de Educación Pública, México
Universidad Iberoamericana
Investigators
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Principal Investigator: Marco A González, Master Instituto Mexicano del Seguro Social

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Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02104973     History of Changes
Other Study ID Numbers: 2007-785-060
2007-01-68854 ( Other Grant/Funding Number: CONACYT )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms