This trial is active, not recruiting.

Condition childhood obesity prevention
Treatments education, social support
Phase phase 4
Sponsor Tehran University of Medical Sciences
Start date December 2012
End date June 2013
Trial size 360 participants
Trial identifier NCT02082080, adjazayery


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
Overweight and obese school children in grades 5 and 6
social support
(No Intervention)

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

Eligibility Criteria

Male or female participants from 9 years up to 14 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Tehran University of Medical Sciences.