- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180802
Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study
August 30, 2014 updated by: Amir H Pakpour, Qazvin University Of Medical Sciences
Motivational interviewing (MI) has been shown to be an effective strategy in targeting obesity in adolescents and parental involvement has been associated with increased effectiveness.
The aim of the study is to evaluate and compare the role of parental involvement in MI interventions for obese adolescents
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
408
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Qazvin, Iran, Islamic Republic of
- Outpatient Pediatric Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI equal or higher than 95th percentile for age and gender
- 13-18 years old
Exclusion Criteria:
- medication with weight gain as side effects
- diagnosed with having eating disorder
- pregnant
- clinical mental health conditions
- psychosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: motivational intervieing group
The behavioral intervention targets were improved eating and physical activity behavior in order to reduce obesity levels.
Each adolescent was encouraged to eat a variety of foods from each of the four major food groups and low-fat alternatives .
Moreover, each adolescent was encouraged to achieve at least 60 minutes of moderate-to-vigorous intensity physical activity daily as recommended by the World Health Organization
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Experimental: motivational interviewi group with parental involvement
an additional single session with parents or guardians over 60 minutes in the clinic
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Active Comparator: Control
The patients received routine care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in BMI
Time Frame: changes from baseline and 12 months follow-up
|
Body Mass Index
|
changes from baseline and 12 months follow-up
|
Child Dietary Self-Efficacy
Time Frame: changes from baseline and 12 months follow-up
|
Child Dietary Self-Efficacy Scale (CDSS)
|
changes from baseline and 12 months follow-up
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Weight Efficacy Lifestyle
Time Frame: changes from baseline and 12 months follow-up
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Weight Efficacy Lifestyle questionnaire (WEL)
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changes from baseline and 12 months follow-up
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Physical Exercise Self-efficacy
Time Frame: changes from baseline and 12 months follow-up
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Physical Exercise Self-efficacy Scale (PES)
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changes from baseline and 12 months follow-up
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changes in physical activity
Time Frame: changes from baseline and 12 months follow-up
|
changes from baseline and 12 months follow-up
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changes in dietary pattern
Time Frame: changes from baseline and 12 months follow-up
|
changes from baseline and 12 months follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in blood cholesterol level
Time Frame: changes from baseline and 12 months follow-up
|
changes from baseline and 12 months follow-up
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changes in blood triglyceride level
Time Frame: changes from baseline and 12 months follow-up
|
changes from baseline and 12 months follow-up
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Changes in body fat percentage
Time Frame: changes from baseline and 12 months follow-up
|
changes from baseline and 12 months follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
July 1, 2014
First Submitted That Met QC Criteria
July 1, 2014
First Posted (Estimate)
July 3, 2014
Study Record Updates
Last Update Posted (Estimate)
September 3, 2014
Last Update Submitted That Met QC Criteria
August 30, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3287
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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