Prevention and Control of Obesity in Primary School Children in Tehran

Phase 4

• Conditions: Childhood Obesity Prevention
• Interventions: Other: Education; Other: Social support

• Registration Number: NCT02082080
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-06
• Study First Submitted: 2013-12-27
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-05
• Last Update Submitted: 2014-03-05
• Study First Posted: 2014-03-10
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese and overweight children, education	Education	Overweight and obese school children in grades 5 and 6
Obese and overweight children, education	Social support	Overweight and obese school children in grades 5 and 6

Primary Outcome Measures

Name	Time	Method
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	Baseline, month 6

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of