KidQuest Family-Based Weight Control
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | February 15, 2008 | ||||
| Start Date ICMJE | July 2001 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
BMI and cardiovascular risk factors [ Time Frame: 0,6,12,18 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
BMI and cardiovascular risk factors | ||||
| Change History | Complete list of historical versions of study NCT00177229 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Eating, activity, and psychosocial functioning [ Time Frame: 0,6,12,18 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Eating, activity, and psychosocial functioning | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | KidQuest Family-Based Weight Control | ||||
| Official Title ICMJE | Family-Based Treatment of Severe Pediatric Obesity | ||||
| 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. |
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| 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 ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Behavior | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 192 | ||||
| Completion Date | May 2006 | ||||
| Primary Completion Date | May 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00177229 | ||||
| Other Study ID Numbers ICMJE | 0405048 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Marsha D. Marcus, Ph.D., Professor of Psychiatry, University of Pittsburgh School of Medicine | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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