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 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012412255N1
Registration date:2013-08-06, 1392/05/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-06, 1392/05/15
Registrant information
Name
Maryam Amini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 2095
Email address
mamini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ministry of Health and Medical Education
Tehran University of Medical Sciences
Expected recruitment start date
2012-11-06, 1391/08/16
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing and evaluating of an interventional model to prevent and control childhood obesity in the fifth-graders. Tehran
Public title
prevention and control of obesity in primary school children in Tehran
Purpose
Prevention
Inclusion/Exclusion criteria
Incusion criteria: BMI-Z-Score > or =1(WHO), students in the fifth or sixth grades
Exclusion criteria: metabolic disorders (hypo or hyperthyroidisim), any disease which interfere with adherence to the intervention, intake of any appetite-reducing drug, doing professional sports, being on a weight reduction diet
Age
From 9 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
360
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
Tehran University of Medical Sciences
Street address
P.O.Box 14155-6446, Tehran
City
Tehran
Postal code
Approval date
2013-04-15, 1392/01/26
Ethics committee reference number
92,D,51,130
Health conditions studied
1
Description of health condition studied
overweight/obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
BMI
Timepoint
before and 6 month after the intervention
Method of measurement
weight by digital scalem height by stadiometer
Secondary outcomes
1
Description
waist an hip circumferences
Timepoint
Before and 6 months after the intervention
Method of measurement
Tape meter
2
Description
Triceps skinfold
Timepoint
Before and 6 months after the intervention
Method of measurement
Caliper
3
Description
Physical activity
Timepoint
Before and 6 months after the intervention
Method of measurement
Standardized questionnaire
4
Description
Energy intake
Timepoint
Before and 6 months after the intervention
Method of measurement
24 h food recall
5
Description
Daily total fat intake
Timepoint
Before and 6 months after the intervention
Method of measurement
24-h food recall
6
Description
Percentage of energy from fat
Timepoint
Before and 6 months after the intervention
Method of measurement
24-h food recall
7
Description
Total daily intake of carbohydrate
Timepoint
Before and 6 months after the intervention
Method of measurement
24-h food recall
8
Description
Percentage of energy from carbohydrate
Timepoint
Before and 6 months after the intervention
Method of measurement
24-h food recall
Intervention groups
1
Description
The approach of intervention is knowledge translation. The intervention will be multi-component including nutrition education (parents and students), increased physical activity, and changing of the schools, environment. The education will be monthly and weekly sessions for parents and students, respectively. The parents are taught about childhood obesity and its causes. They will also learn strategies to increase physical activity and vegetable and fruit consumption, as well as decrease consumption of high energy foods by their children.Nutrition education of the students will be done done by health instructors of the schools who have been trained for this work. The content of the education will be mainly Iranian food pyramid, food groups, and energy value of the food groups. To increase physical activity of the students, weekly exercise sessions under supervision of their schools’ coach will be done in schools. Finally, the school canteens will becolsely supevised with particular attention to the type of foods (snacks, etc.) offered for sale.
Category
Lifestyle
2
Description
During the intervention period nothing will be done in comparison schools. At the end of intervention an educational session for parents(1.5 h) will be held for all comparison schools.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary schools of Tehransar area, Tehran
Full name of responsible person
Maryam Amini
Street address
Department of Nutrition & Biochemistry, School of Public Health, Poorsina Ave., Qods Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotoohi
Street address
Central building of Tehran University of Medical Sciences, Qods Ave.,Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Ministry of Health and Medical Education
Full name of responsible person
Dr. Zahra Abdollahi
Street address
Department of Nutrition, Central building of Ministry of Health and Medical Education, Hafez intersection, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Health and Medical Education
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
Department of Community Nutrition, School of Nutrition & Dietetics, Tehran University of Medical Sci
Full name of responsible person
Maryam Amini
Position
PhD(Nutrition) candidate
Other areas of specialty/work
Street address
Department of Nutrition & Biochemistry, School of Public Health, Poursina Ave., Qods Ave.
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
mamini@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Community Nutrition, School of Nutrition and Dietetics, Tehran University of Medical S
Full name of responsible person
Dr. Abolghassem Djazayery
Position
Professor Emeritus
Other areas of specialty/work
Street address
Department of Nutrition & Biochemistry, School of Health, Poursina Ave., Qods Ave.
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
jazaiers@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Community Nutrition, School of nutrition and School Nutrition and Dietetics
Full name of responsible person
Maryam Amini
Position
PhD (Nutrition) candidate
Other areas of specialty/work
Street address
Nutrition & Biochemistry Department, School of Health, Poursina Ave., Qods Ave.
City
Tehran
Postal code
Phone
+98 21 6640 2095
Fax
Email
mamini@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)