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
The aim of this study was to examine 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.
This study is a field trial study.
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
Interventions include Diet and physical activity changes.
Main outcome measures include FTO and IRX3 gene expression changes and anthropometric indices.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020925699N2
Registration date:2016-04-24, 1395/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-24, 1395/02/05
Registrant information
Name
Saeid Doaei
Name of organization / entity
National Nutrition and Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6643 6744
Email address
sdoaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Research Institute and Health education and health promotion office
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Public title
Examinig the mutual interactions of Genetics, Lifestyle and Anthropometric measurements
Purpose
Prevention
Inclusion/Exclusion 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
Age
From 12 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
752
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute
Street address
National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
009821
Approval date
2016-02-29, 1394/12/10
Ethics committee reference number
Ir.sbmu.nnftri.rec.1394.22
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
FTO gene expression
Timepoint
Baseline, 3 months after intervention
Method of measurement
Real time RT PCR
2
Description
IRX3 gene expression
Timepoint
Baseline, 3 months after intervention
Method of measurement
Real time RT PCR
3
Description
Lifestyle
Timepoint
Baseline, 3 months after intervention
Method of measurement
Questionaire
Secondary outcomes
1
Description
BMI
Timepoint
Baseline, 3 month after intervention
Method of measurement
WHO standard charts
Intervention groups
1
Description
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.
Category
Lifestyle
2
Description
Control group:
Observation
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Entefazeh School
Full name of responsible person
Mr Ghadiri
Street address
ِDehkade Olympik St.
City
Tehran
2
Recruitment center
Name of recruitment center
Matin School
Full name of responsible person
Mr Akbari
Street address
ِDehkade olympik St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mrs. Hoseini
Street address
Shahid Beheshti University of Medical Sciences, Velenjak, Tehran.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Health education office of Health ministry
Full name of responsible person
Dr. Shahram rafiei far
Street address
Eivanak St., Ministry of Health, Health Education office of Ministry of Health
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Health education office of Health ministry
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeid Doaei
Position
PhD of Nutrition sciences
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Tehran, IRAN.
City
Tehran
Postal code
009821
Phone
+216 690261
Fax
Email
sdoaei@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Naser Kalantari
Position
Pediatrician
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Tehran, IRAN.
City
Tehran
Postal code
009821
Phone
+216 690261
Fax
Email
nkalantari1334@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeid Doaei
Position
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Tehran, IRAN.
City
Tehran
Postal code
009821
Phone
+98 21 6643 6744
Fax
Email
sdoaei@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)