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

Yale University

Status

Completed

Conditions

Hyperinsulinemia

Insulin Resistance

Pediatric Obesity

Treatments

Behavioral: weight management program

Study type

Interventional

Funder types

Other

Identifiers

NCT00409422

HIC 15994

Details and patient eligibility

About

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.

Full 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).

Sex

All

Ages

8 to 16 years old

Volunteers

No Healthy Volunteers

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