(1)Objectives: The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) on weight loss in obese and overweight adolescents.
(2)Designe: This study is a randomized controlled trial that will be conducted on obese or overweight children and their parents.
(3)Setting and conduct: 120 Overweight and obese adolescents aged 13–18 y is selected from schools, they randomly assigne to CBT or no treatment (control). Weight, height, hip and waist circumferences, BMI and body composition are measured. Food intake, Weight-Efficacy of Life style, quality of life, Physical activity are asked by valid questionnaires.
(4)Participants including major eligibility criteria: Participants will be included if they are overweight and obes 13-18 aged adolescent (BMI>85%). Participants will be excluded if they are involved in other weight-loss programs, are unwilling to attend sessions, using drugs which affect on weight or had a medical cause for their obesity (eg,endocrine disorders, etc).
(5) Intervention: Intervention group recieves CBT consisted of 6 weekly sessions, followed by five telephone or face to face sessions. All assessments will conducted at baseline and six month later inorder to evaluate effectiveness of this treatment method.
(6)main outcome measures (variables): Weight changes will be examined in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110530707N1
Registration date:2017-01-22, 1395/11/03
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Seyedeh Fatemeh Miri
Name of organization / entity
Qazvin Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
f.miri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents
Public title
Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Participants will be included if they are overweight and obes; 13-18 aged adolescent; (BMI>85%).
Exclusion criteria:Participants will be excluded if they are involved in other weight-loss programs; are unwilling to attend sessions; using drugs which affect on weight; have a medical cause for their obesity (eg,endocrine disorders etc).
Age
From 13 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Qazvin Medical Science University Ethics committee
Street address
Medical Science University, Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.QUMS.REC.1395.172
Health conditions studied
1
Description of health condition studied
overweight or obesity
ICD-10 code
E65, E66,
ICD-10 code description
Obesity and other hyperalimentation / Obesity due to excess calories
Primary outcomes
1
Description
weight
Timepoint
before intervention and after 6 month
Method of measurement
balance scale
Secondary outcomes
1
Description
body mass index
Timepoint
before and after intervention
Method of measurement
weigh(kg)/(height)2
2
Description
waist circumference
Timepoint
baseline and 6 month after intervention
Method of measurement
meter
3
Description
hip circumference
Timepoint
at baseline and 6 month after intervention
Method of measurement
meter
4
Description
energy intake
Timepoint
at baseline and 6 month after intervention
Method of measurement
food frequency questionnair
5
Description
physical activity
Timepoint
at baseline and 6 month after intervention
Method of measurement
physical activity questionnair
6
Description
health-related quality of life
Timepoint
at baseline and 6 month after intervention
Method of measurement
quality of life questionnaire
7
Description
self efficacy
Timepoint
at baseline and 6 month after intervention
Method of measurement
questionnaire
8
Description
body composition
Timepoint
at baseline and 6 month after intervention
Method of measurement
body analyser
Intervention groups
1
Description
Intervention group: Cognitive behavioral therapy (CBT) will be used in this study. Intervention group will receive CBT consisted of six weekly, face to face sessions.
Category
Behavior
2
Description
Control group: This group will not receive any treatment during the study.they will receive counseling sessions at the end of study similar to intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools
Full name of responsible person
Seyedeh Fatemeh Miri
Street address
Medical Science University, Shahid Bahonar Blvd
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin Medical Science University
Full name of responsible person
Vice chancellor for research, Qazvin Medical Science University
Street address
Medical Science University, Shahid Bahonar Blvd
City
Qazvin
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, Qazvin Medical Science University
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
Qazvin Medical Science University
Full name of responsible person
Seyedeh Fatemeh Miri
Position
MSc student
Other areas of specialty/work
Street address
Qazvin Medical University, Shahid Bahoonar Blvd
City
Qazvin
Postal code
59811-34197
Phone
+98 28 3337 4872
Fax
Email
fmiri.nut@gmail.com; f.miri@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Social Determinants of Health Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Amir H Pakpour
Position
PhD, Health education
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Social Determinants of Health Research Center
City
Qazvin
Postal code
Phone
+98 28 3323 9259
Fax
Email
Pakpour_amir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin Medical Science University
Full name of responsible person
Seyedeh Fatemeh Miri
Position
MSc student
Other areas of specialty/work
Street address
Medical Science University, Shahid Bahoonar Blvd
City
Qazvin
Postal code
Phone
+98 28333360015
Fax
Email
f.miri@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)