Skip to main content
Clinical Trials/NCT02082080
NCT02082080
Unknown
Phase 4

Prevention and Control of Obesity in Primary School Children in Tehran

Tehran University of Medical Sciences1 site in 1 country360 target enrollmentDecember 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Childhood Obesity Prevention
Sponsor
Tehran University of Medical Sciences
Enrollment
360
Locations
1
Primary Endpoint
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
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials