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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Pediatric Obesity, Insulin Resistance, Hyperinsulinemia

Intervention / Treatment
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* Behavioral: weight management program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: weight management program|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight |  | 6 months and 1 year | 
| body mass index |  | 6 months and 1 year | 
| % body fat |  | 6 months and 1 year | 
| lipids |  | 6 months and 1 year | 
| blood pressure |  | 6 months and 1 year | 
| glucose |  | 6 months and 1 year | 
| insulin |  | 6 months and 1 year | 
| HOMA index |  | 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| planned to compare dieting with non-dieting approach in weight management group |  | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric obesity, overweight, insulin resistance, hyperinsulinemia, weight management program, family-based