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

Yale University1 site in 1 country200 target enrollmentMay 2002

ConditionsPediatric Obesity Insulin Resistance Hyperinsulinemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pediatric Obesity
Sponsor: Yale University
Enrollment: 200
Locations: 1
Primary Endpoint: weight
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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).

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

February 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yale University

Eligibility 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