Insulin Resistance Clinical Trial
Official title:
Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 2007 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 16 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Yale University School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weight | 6 months and 1 year | ||
Primary | body mass index | 6 months and 1 year | ||
Primary | % body fat | 6 months and 1 year | ||
Primary | lipids | 6 months and 1 year | ||
Primary | blood pressure | 6 months and 1 year | ||
Primary | glucose | 6 months and 1 year | ||
Primary | insulin | 6 months and 1 year | ||
Primary | HOMA index | 6 months and 1 year | ||
Secondary | planned to compare dieting with non-dieting approach in weight management group | 6 months and 1 year |
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