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Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children

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: NCT00409422
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : June 24, 2008
Information provided by:
Yale University

Brief Summary:
To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Insulin Resistance Hyperinsulinemia Behavioral: weight management program Not Applicable

Detailed Description:
Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
Study Start Date : May 2002
Actual Primary Completion Date : October 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Primary Outcome Measures :
  1. weight [ Time Frame: 6 months and 1 year ]
  2. body mass index [ Time Frame: 6 months and 1 year ]
  3. % body fat [ Time Frame: 6 months and 1 year ]
  4. lipids [ Time Frame: 6 months and 1 year ]
  5. blood pressure [ Time Frame: 6 months and 1 year ]
  6. glucose [ Time Frame: 6 months and 1 year ]
  7. insulin [ Time Frame: 6 months and 1 year ]
  8. HOMA index [ Time Frame: 6 months and 1 year ]

Secondary Outcome Measures :
  1. planned to compare dieting with non-dieting approach in weight management group [ Time Frame: 6 months and 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 8-16 years old
  • BMI >95th percentile for age/gender based on CDC
  • Both primary caregiver/parent and child must agree to participate in the nutrition classes

Exclusion Criteria:

  • endocrinopathies, including hypothyroidism and diabetes
  • Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
  • Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
  • Any use of medication (steroids, for ex.) that contributes to excess adiposity.
  • Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
  • Any concurrent membership in a weight management program.
  • Inability or unwillingness of parent to accompany the child to nutrition classes.
  • Pregnancy

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): NCT00409422

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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
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Principal Investigator: Sonia Caprio, MD Yale University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sonia Caprio, MD, Yale University School of Medicine Identifier: NCT00409422    
Other Study ID Numbers: HIC 15994
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: June 24, 2008
Last Verified: June 2008
Keywords provided by Yale University:
pediatric obesity
insulin resistance
weight management program
Additional relevant MeSH terms:
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Insulin Resistance
Pediatric Obesity
Nutrition Disorders
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases