Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families
November 2, 2012 updated by: University of Kansas
Effectiveness of a Treatment Program for Pediatric Obesity
The current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families.
The target intervention was compared to an enhanced standard of care treatment.
The impact of both treatment programs on numerous outcomes was explored.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings.
A number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families.
As called for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (QOL).
Because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention.
Finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.
Study Type
Interventional
Enrollment (Actual)
93
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
-
-
Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
Lawrence, Kansas, United States, 66045
- University of Kansas
-
-
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
7 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Child between ages 7 and 17 (inclusive)
- Child BMI at or above the 85th percentile based on norms provided for age and gender
- Child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation
- Child's parent/caregiver is willing to participate with the child in the program
Exclusion Criteria:
- Presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol
- Current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Brief Family Intervention (Primarily education)
Behaviorally based family group intervention using standard education and nutrition counseling.
Three hours of client contact
|
3 hours of contact with registered dietician for education and nutritional counseling.
|
|
Experimental: Positively Fit
12 week (90 minute per session) behavioral group intervention for children and their parents.
Children and parent attend parallel group with identical (but developmentally appropriate) information presented.
|
12-week group intervention for children with obesity and their parents/caregivers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
BMI Percentile Change
Time Frame: Treatment completion, 1 year follow up
|
Treatment completion, 1 year follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)
Time Frame: treatment completion, one year follow up
|
treatment completion, one year follow up
|
|
Child Psychosocial Adjustment -- the Behavioral Assessment System for Children- Parent report form (BASC-PRF) and the BASC-Child Self Report (BASC-CSR; Reynolds & Kamphaus, 2002)
Time Frame: Treatment completion, one year follow up
|
Treatment completion, one year follow up
|
|
Cost-effectiveness
Time Frame: Treatment completion, one year follow up
|
Treatment completion, one year follow up
|
|
Consumer Satisfaction
Time Frame: Treatment completion
|
Treatment completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ric G Steele, Ph.D., University of Kansas
- Principal Investigator: Ann M. Davis, Ph.D., University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
July 1, 2006
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 17, 2006
First Submitted That Met QC Criteria
August 17, 2006
First Posted (Estimate)
August 18, 2006
Study Record Updates
Last Update Posted (Estimate)
November 4, 2012
Last Update Submitted That Met QC Criteria
November 2, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R40MC06631-01-00
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.