Prevention and Control of Obesity in Primary School Children in Tehran

NCT02082080 | Unknown Phase 4 DMC

• 1 other identifier: adjazayery
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity Prevention

Outcome Measures

Primary Outcomes (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

  Baseline, month 6

Study Arms (2)

Obese and overweight children, education

ACTIVE COMPARATOR

Overweight and obese school children in grades 5 and 6

Other: Education; Other: Social support

Obese and overweight children

NO INTERVENTION

Interventions

Education OTHER

Obese and overweight children, education

Social support OTHER

Obese and overweight children, education

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: March 10, 2014
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

IR (1)