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

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00409422
First received: December 6, 2006
Last updated: June 20, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention
Pediatric Obesity
Insulin Resistance
Hyperinsulinemia
 Behavioral: weight management program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • weight [ Time Frame: 6 months and 1 year ]
  • body mass index [ Time Frame: 6 months and 1 year ]
  • % body fat [ Time Frame: 6 months and 1 year ]
  • lipids [ Time Frame: 6 months and 1 year ]
  • blood pressure [ Time Frame: 6 months and 1 year ]
  • glucose [ Time Frame: 6 months and 1 year ]
  • insulin [ Time Frame: 6 months and 1 year ]
  • HOMA index [ Time Frame: 6 months and 1 year ]

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

Estimated Enrollment: 200
Study Start Date: May 2002
Study Completion Date: February 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409422

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Sonia Caprio, MD Yale University
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sonia Caprio, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00409422     History of Changes
Other Study ID Numbers: HIC 15994
Study First Received: December 6, 2006
Last Updated: June 20, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Yale University:
pediatric obesity
overweight
insulin resistance
 hyperinsulinemia
weight management program
family-based

Additional relevant MeSH terms:
Hyperinsulinism
Insulin Resistance
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013