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Prevention and Control of Obesity in Primary School Children in Tehran

Primary Purpose

Childhood Obesity Prevention

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Education
Social support
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity Prevention

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Obese and overweight children, education

Obese and overweight children

Arm Description

Overweight and obese school children in grades 5 and 6

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 27, 2013
Last Updated
March 5, 2014
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02082080
Brief Title
Prevention and Control of Obesity in Primary School Children in Tehran
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obese and overweight children, education
Arm Type
Active Comparator
Arm Description
Overweight and obese school children in grades 5 and 6
Arm Title
Obese and overweight children
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Education
Intervention Type
Other
Intervention Name(s)
Social support
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Prevention and Control of Obesity in Primary School Children in Tehran

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