- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104973
Obesity Prevention in Schoolchildren (CRECES)
Design and Evaluation of a Strategy to Prevent Overweight and Obesity in Schoolchildren in Mexico City
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Distrito Federal
-
Mexico, Distrito Federal, Mexico, 06720
- Instituto Mexicano del Seguro Social
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Usual care
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: 0, 12 months
|
We will evaluate the change in body mass index
|
0, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adiposity
Time Frame: 0, 12 months
|
We will evaluate the change in percent of fat mass
|
0, 12 months
|
Physical activity
Time Frame: 0, 12 months
|
We will evaluate the change in the frequency and kinf of physical activity
|
0, 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marco A González, Master, Instituto Mexicano del Seguro Social
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-785-060
- 2007-01-68854 (Other Grant/Funding Number: CONACYT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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