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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: IRCT
Last refreshed on: 22 February 2018
Main ID:  IRCT2016020925699N2
Date of registration: 2016-04-24
Prospective Registration: No
Primary sponsor: Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Public title: Examinig the mutual interactions of Genetics, Lifestyle and Anthropometric measurements
Scientific title: Examining the mutual interactions of genetics, lifestyle and anthropometric measurements and assessment of influence of a health promotion intervention on anthropometric measurements and FTO and IRX3 genes expression among 12 to 18 years old boys
Date of first enrolment: 2016-03-01
Target sample size: 752
Recruitment status: Complete
URL:  http://en.irct.ir/trial/21447
Study type:  interventional
Study design:  Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.  
Phase:  N/A
Countries of recruitment
Iran (Islamic Republic of)
Contacts
Name: Saeid Doaei   
Address:  Shahid Beheshti University of Medical Sciences, Tehran, IRAN. 009821 Tehran Iran (Islamic Republic of)
Telephone: +216 690261
Email: sdoaei@sbmu.ac.ir
Affiliation:  Shahid Beheshti University of Medical Sciences
Name: Naser Kalantari   
Address:  Shahid Beheshti University of Medical Sciences, Tehran, IRAN. 009821 Tehran Iran (Islamic Republic of)
Telephone: +216 690261
Email: nkalantari1334@gmail.com
Affiliation:  Shahid Beheshti University of Medical Sciences
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion Criteria:
Age between 12 to 18 years; Completion the consent forms by student and his parents; Lack of diseases effective on weight and body composition; Lack of use of effective drugs on weight and body composition; Participating in educational, cultural and sportive programs.
Exclusion criteria:
Get a weight affecting disease

Exclusion criteria:

Age minimum: 12 years
Age maximum: 18 years
Gender: Male
Health Condition(s) or Problem(s) studied
Obesity.
Obesity due to excess calories
Obesity due to excess calories
Intervention(s)
Intervention 1: Intervention group:
3 month lifestyle intervention based on Ottawa charter will be performed. The interventions include: healthy policy, create supportive environment, community action, development of personal skills, and health services reorientation. Intervention 2: Control group:
Observation.
Control group:
Observation
Intervention group:
3 month lifestyle intervention based on Ottawa charter will be performed. The interventions include: healthy policy, create supportive environment, community action, development of personal skills, and health services reorientation.
Lifestyle
Primary Outcome(s)
IRX3 gene expression. Timepoint: Baseline, 3 months after intervention. Method of measurement: Real time RT PCR.
FTO gene expression. Timepoint: Baseline, 3 months after intervention. Method of measurement: Real time RT PCR.
Lifestyle. Timepoint: Baseline, 3 months after intervention. Method of measurement: Questionaire.
Secondary Outcome(s)
BMI. Timepoint: Baseline, 3 month after intervention. Method of measurement: WHO standard charts.
Secondary ID(s)
Source(s) of Monetary Support
Health education office of Health ministry
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Secondary Sponsor(s)
Health education office of Health ministry
Ethics review
Status: Approved
Approval date:
Contact:
National Nutrition and Food Technology Research Institute
Results
Results available:
Date Posted:
Date Completed:
URL:
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