NCT00409422

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 8 Years – 16 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Pediatric Obesity
• Insulin Resistance
• Hyperinsulinemia

Interventions

Type	Name	Description
BEHAVIORAL	weight management program

Timeline

• Start date: 2002-05-01
• Primary completion: 2006-10-01
• Completion: 2007-02-01
• First posted: 2006-12-08
• Last updated: 2008-06-24

Locations

1 site across 1 country: United States