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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00409422

Collaborator

(none)

200

Enrollment

Location

57.1

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity Insulin Resistance Hyperinsulinemia	Behavioral: weight management program	N/A

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).

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

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

planned to compare dieting with non-dieting approach in weight management group [6 months and 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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