Prevention and Control of Obesity in Primary School Children in Tehran

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Childhood Obesity Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Obese and overweight children, education

Overweight and obese school children in grades 5 and 6

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

Social support

Intervention Type OTHER

Obese and overweight children

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education

Intervention Type OTHER

Social support

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No