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Prevention and Control of Obesity in Primary School Children in Tehran

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082080
Recruitment Status : Unknown
Verified March 2014 by Tehran University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
This study evaluates the effect of an interventional model for preventing and controlling overweight and obesity in male and female fifth-graders. First, based on WHO (World Health Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be screened. Then from the screened students 30 students with the following inclusion criteria will be recruited: not metabolically ill, not on a weight losing diet and not professionally athlete. For selected students BMI-Z score as primary outcome will be calculated. Demographic data, as well as data on waist and hip circumference, triceps skin-fold thickness, food intake for 3 days (2 ordinary week days and 1 weekend) and physical activity will be collected at the beginning and at end of the 6-month intervention. The approach of the study will be Health Promoting Schools. The intervention includes three components, i.e., nutrition education (students and parents), increased physical activity, and changing environment (food items offered in schools' canteens). Nutrition education will be imparted (a 30-minute session per week) by health instructors; physical activity will be done under the supervision of the school coaches (2 one-hour sessions per week). Parents' education (a 1.5-hour session) will be monthly. Finally the efficacy of the intervention will be determined and reported.

Condition or disease Intervention/treatment Phase
Childhood Obesity Prevention Other: Education Other: Social support Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : December 2012
Actual Primary Completion Date : June 2013

Arm Intervention/treatment
Active Comparator: Obese and overweight children, education
Overweight and obese school children in grades 5 and 6
Other: Education
Other: Social support
No Intervention: Obese and overweight children



Primary Outcome Measures :
  1. Change from baseline in pain on the 11-point Short Pain Scale (SPS-11) at week 24 Change from baseline BMI (Body Mass Index) at 6 months [ Time Frame: Baseline, month 6 ]


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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI-Z-Score> or =1 (WHO)
  • Students in the fifth or sixth grades

Exclusion Criteria:

  • Metabolic disorders (hypo or hyperthyroidism)
  • Any disease which interfere with adherence to the intervention
  • Intake of any appetite-reducing drug
  • Doing professional sports
  • Being on a weight reduction diet

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): NCT02082080


Locations
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Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02082080    
Other Study ID Numbers: adjazayery
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms