Protocol summary

Summary
Abstract Purposes: The theory of obesity-related behaviors in adolescents (TORBA) emerged from a qualitative study in Iran and presents a new approach to the weight-gain process during adolescence. This study aims at evaluating the effectiveness of a TORBA-based intervention on obese adolescents’ weight reduction and its related factors. Methods: This is a randomized clinical trial conducted on 115 overweight adolescents (50% female) aged 12 to 17 years, and their parents will be recruited from healthcare centers located in district 13 of Tehran. All participants will attend a data collection, involving assessments of obesity-related behaviors, laboratory indices, body composition, body mass index and health-related quality of life, which will be conducted at baseline, after the intervention phase, and after maintenance phases (6 months and a year after intervention). Following completion of all pre intervention assessments, participants will be randomly assigned in to the intervention or control groups. The TORBA-based cognitive behavioral intervention, of this study, consists of face- to-face educational sessions for adolescents and their parents. A pilot study will establish the affordability of study educational packages. The study interventions involve improvement in diet, physical activity, and stress management which mainly implement through motivational interviews. Improvements in obesity-related behaviors, BMI, body composition are primary outcomes and secondary outcomes include improvement in laboratory indices and health-related quality of life. Conclusion: Data obtained in this study will provide valuable information about the effectiveness of a behavioral cognitive intervention, designed on a local-tailored theoretical framework and which could be used for designing future national strategies to prevent obesity in Iranian adolescents.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012235440N1
Registration date: 2011-02-18, 1389/11/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-02-18, 1389/11/29
Registrant information
Name
Parisa Amiri
Name of organization / entity
Obesity research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 9309
Email address
amiri@endocrine.ac.ir
Recruitment status
Recruitment complete
Funding source
Obesity research center, research Institute for endocrine Sciences, Shahid Beheshti University of medical sciences
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a theory-based intervention on obesity-related behaviors, laboratory indices, body composition, body mass index and health-related quality of life in overweight adolescents
Public title
Effectiveness of an educational program to adolescents' weight management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. age 12-17 2. adolescents who were overweight or obese according to WHO cut off 3. living with a parent or adult caregiver who will prepare to participate in the study. Exclusion criteria: 1. they have a physical disability that prevent them to participate in the program
Age
From 12 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 115
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
Research Institute for Endocrine Sciences
Street address
Obesity research center, research Institute for endocrine Sciences, Shahid Beheshti University of medical sciences
City
Tehran
Postal code
Approval date
2005-10-09, 1384/07/17
Ethics committee reference number
750EC

Health conditions studied

1

Description of health condition studied
overweight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
obesity-related behaviors
Timepoint
base line, 3, 6 and 12 months after intervention
Method of measurement
Obesity Predictors in Adolescents Questionnaire (OPAQ), FFQ, Physical activity questionnaire

2

Description
laboratory indices
Timepoint
base line, 6 and 12 months after intervention
Method of measurement
measuring of FBS, Lipid profile and Insulin

3

Description
BMI
Timepoint
base line, 3, 6 and 12 months after intervention
Method of measurement
Weight (Kg)/Hight2 (m)

4

Description
Body composition
Timepoint
base line, 6 and 12 months after intervention
Method of measurement
Body composition analyzer

Secondary outcomes

1

Description
health-related quality of life
Timepoint
baseline, a year after intervention
Method of measurement
Iranian version of pediatric quality of life inventory PedsQL

Intervention groups

1

Description
intervention group : The intervention program encompassed intensive and maintenance phases.The intensive phase consisted of 17 focus group discussions, twice a week and a 45 minute face-to-face session of nutritional counseling at the end of program. The maintenance programs included seven focus group discussions during six months. The study intervention involved improvement in diet, increase in the level of physical activity, and improvement of stress management which implemented through motivational interviews, group discussions, and educational publications
Category
Lifestyle

2

Description
Control: conventional diet counseling
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
ُSalavati and Alghadir health care center
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences
Full name of responsible person
Fereidoun Azizi
Street address
Velenjak, Yaman Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Sciences
Proportion provided by this source
100
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
Obesity research Center, Research Institute for Endocrine Sciences
Full name of responsible person
Parisa Amiri
Position
researcher/ Ph.D
Other areas of specialty/work
Street address
Obesity Research Center, Research Institute for Endocrine Sciences, Yaman Ave., Velenjak
City
Tehran
Postal code
Phone
+98 21 8861 2947
Fax
Email
amiri@endocrine.ac.ir , parisaamiri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Me
Full name of responsible person
Parisa Amiri
Position
Ph.D/ Researcher
Other areas of specialty/work
Street address
Obesity Research Center, Research Institute for Endocrine Sciences, Yaman Ave., Velenjak
City
Tehran
Postal code
Phone
+98 21 8861 2947
Fax
Email
amiri@endocrine.ac.ir , parisaamiri@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Obesity research Center, Research Institute for Endocrine Sciences
Full name of responsible person
Parisa Amiri
Position
Ph.D/ researcher
Other areas of specialty/work
Street address
Obesity Research Center, Research Institute for Endocrine Sciences, Yaman Ave., Velenjak
City
Tehran
Postal code
Phone
+98 21 8861 2944
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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