Protocol summary
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Study aim
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The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) on weight loss in obese and overweight adolescents
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Design
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The present study is a prospective randomized controlled trial (RCT) comparing the effect of CBT on weight reduction among overweight and obese Iranian adolescents.
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Settings and conduct
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The adolescents will be recruited from four outpatient pediatric clinics in Qazvin .
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 13–18 years, BMI ≥85th percentile for age and gender, and ability to attend CBT sessions. Exclusion criteria : adolescents with other causes of obesity such as Cushing Disease and hypoparathyroidism, being pregnant, having clinical mental health conditions or psychosis, taking specific medications that affected their weight (e.g. corticosteroids, anxiolytics), and participating in another weight loss RCT.
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Intervention groups
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CBT treatment sessions will be based on treatment strategies in the intervention group comprised six face-to-face sessions for adolescents and two sessions for their parents. In all sessions, nutritional recommendations and diet of the adolescents will be evaluated.
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Main outcome variables
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Primary outcomes will be changes in BMI, Child Dietary Self-Efficacy Scale (CDSS), Weight Efficacy Lifestyle questionnaire (WEL), Physical Exercise Self-Efficacy Scale (PES), Pediatric Quality of Life Inventory (PedsQL™ 4.0 Generic Core Scales), and self-reported physical activity and diet
General information
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Reason for update
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We had been registered this trial 6 years before prospectively. But it has recently changed unto a retrospective status. We received the following message from IRCT “ Please note that the existing validation errors in your trial is because this trial has been approved while the previous version of IRCT software was in use. Please check all the errors carefully and update accordingly. some of the major changes include reformatting protocol summary, entering inclusion and exclusion criteria in "one phrase for each criteria" format, providing a sharing plan, and adding more contact information.” Therefore, we have now updated recruiting time.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016110530707N1
Registration date:
2017-01-22, 1395/11/03
Registration timing:
prospective
Last update:
2023-06-13, 1402/03/23
Update count:
1
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Registration date
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2017-01-22, 1395/11/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Investigator
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Expected recruitment start date
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2017-02-03, 1395/11/15
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Expected recruitment end date
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2017-06-15, 1396/03/25
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Actual recruitment start date
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2017-02-03, 1395/11/15
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Actual recruitment end date
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2017-08-12, 1396/05/21
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Trial completion date
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2018-03-06, 1396/12/15
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Scientific title
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Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents
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Public title
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Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age 13–18 years
BMI ≥85th percentile for age and gender
ability to attend CBT sessions
Exclusion criteria:
Cushing Disease
hypoparathyroidism
being pregnant
having clinical mental health conditions or psychosis, taking specific medications that affected their weight
participating in another weight loss RCT
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Age
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From 13 years old to 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
110
Actual sample size reached:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Each adolescent will be recruited at the pediatric clinic to which they referred for treatment. Randomization will be performed after checking eligibility criteria, signing of informed consent, and baseline assessment. An independent biostatistician will randomize the adolescents into two groups (CBT and TAU) using software program and stratifying with the pediatric clinics.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-10-19, 1395/07/28
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Ethics committee reference number
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IR.QUMS.REC.1395.172
Health conditions studied
1
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Description of health condition studied
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overweight or obesity
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ICD-10 code
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E65, E66,
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ICD-10 code description
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Obesity and other hyperalimentation / Obesity due to excess calories
Primary outcomes
1
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Description
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weight
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Timepoint
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before intervention and after 6 month
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Method of measurement
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balance scale
Secondary outcomes
1
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Description
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body mass index
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Timepoint
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before and after intervention
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Method of measurement
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weigh(kg)/(height)2
2
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Description
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waist circumference
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Timepoint
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baseline and 6 month after intervention
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Method of measurement
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meter
3
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Description
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hip circumference
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Timepoint
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at baseline and 6 month after intervention
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Method of measurement
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meter
4
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Description
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energy intake
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Timepoint
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at baseline and 6 month after intervention
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Method of measurement
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food frequency questionnair
5
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Description
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physical activity
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Timepoint
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at baseline and 6 month after intervention
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Method of measurement
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physical activity questionnair
6
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Description
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health-related quality of life
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Timepoint
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at baseline and 6 month after intervention
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Method of measurement
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quality of life questionnaire
7
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Description
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self efficacy
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Timepoint
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at baseline and 6 month after intervention
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Method of measurement
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questionnaire
8
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Description
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body composition
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Timepoint
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at baseline and 6 month after intervention
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Method of measurement
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body analyser
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available