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KidQuest Family-Based Weight Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177229
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 18, 2008
National Institutes of Health (NIH)
Information provided by:
University of Pittsburgh

Brief Summary:
The purpose of this study is to determine if a family based diet and exercise program is helpful for extremely overweight children aged 8-12, and to compare this approach to standard medical management of severe pediatric obesity.

Condition or disease Intervention/treatment Phase
Behavior Behavioral: Family-based treatment Not Applicable

Detailed Description:

The prevalence of pediatric obesity has increased significantly, and approximately 11% of American children and adolescents are obese. Of particular concern, the greatest increase in prevalence has occured among the heaviest children. Severe pediatric obesity (defined as > 150% of ideal body weight for height) is associated with higher rates of medical and psychosocial morbidity than milder obesity is. Moreover, severely obese children are likelier than less severely obese children are to become obese adults and suffer the long-term health consequences of obesity. Although the efficacy of family-based behavioral weight control programs in the treatment of moderate pediatric obesity is well established, few studies have focused on the treatment of severe obesity. Thus in this application, we propose a randomized controlled trial to evaluate the efficacy of a family-based behavioral weight control program in the management of severe pediatric obesity.

Two hundred children aged 8-12 will be randomized to a six-month family-based program or usual care, and will complete assessments at pre- and post- treatment and 6-month and 12-month follow-ups. We hypothesized that: 1) Children who participate in the family-based program, when compared to children who receive usual care, will show favorable changes in body mass index, body composition, food intake, activity level, and cardiovascular risk factors. 2) Children who participate in the family-based program, when compared to children who receive usual care, will report higher levels of self-esteem, social competence and health-related quality of life, and report fewer psychiatric symptoms. A secondary aim of the the proposed investigation is to examine the relationships among gender, race, compliance to diet and exercise. level of parent adherence and treatment outcome. The proposed investigation is significant as the first effort to systematically evaluate a treatment program for severely obese children. It will provide data about a serious public health problem and establish a foundation for programmatic research to develop effective treatments for an underserved population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family-Based Treatment of Severe Pediatric Obesity
Study Start Date : July 2001
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Arm Intervention/treatment
No Intervention: A
Enhanced usual care: 2 free, individual consultations with a nutritionist over first 6 months. Medical monitoring throughout study period.
Experimental: B Behavioral: Family-based treatment
20 weekly group contacts with individual coaching over first 6 months, brief monthly contacts over next 6 months, no contacts over last 6 months. Medical monitoring throughout study period.

Primary Outcome Measures :
  1. BMI and cardiovascular risk factors [ Time Frame: 0,6,12,18 ]

Secondary Outcome Measures :
  1. Eating, activity, and psychosocial functioning [ Time Frame: 0,6,12,18 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be >150% of ideal body weight for height and age based on norms of the World Health Organization.
  • Have at least one parent or guardian who will participate in the treatment program with child.

Exclusion Criteria:

  • Mental retardation, pervasive developmental disorder or psychosis, psychiatric symptomatology sufficiently severe to require immediate treatment.
  • Genetic obesity syndrome as determined by the study physician.
  • Currently receiving obesity treatment and/or participating in a weight management program.
  • Inability to engage in moderate exercise defined as 30 minutes of vigorous activity on most days of the week.
  • Acute or severe medical conditions that require aggressive weight management intervention (e.g., diabetes pseudotumor cerebri, or hypoventilation).
  • Regular use of a medication that affects body weight such as oral steroids or antipsychotic medications.
  • Taking stimulant or antidepressant medication for a period < four months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177229

Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
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Principal Investigator: Marsha D. Marcus, Ph.D. Western Psychiatric Insitute & Clinic
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Responsible Party: Marsha D. Marcus, Ph.D., Professor of Psychiatry, University of Pittsburgh School of Medicine Identifier: NCT00177229    
Other Study ID Numbers: 0405048
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: February 2008