Clinical trial NCT00409422: Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
Official title: Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Insulin Resistance
Hyperinsulinemia
Keywords: pediatric obesity
overweight
insulin resistance
hyperinsulinemia
weight management program
family-based
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: weight
timeFrame: 6 months and 1 year
measure: body mass index
timeFrame: 6 months and 1 year
measure: % body fat
timeFrame: 6 months and 1 year
measure: lipids
timeFrame: 6 months and 1 year
measure: blood pressure
timeFrame: 6 months and 1 year
measure: glucose
timeFrame: 6 months and 1 year
measure: insulin
timeFrame: 6 months and 1 year
measure: HOMA index
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: planned to compare dieting with non-dieting approach in weight management group
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Sonia Caprio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. JAMA. 2007 Jun 27;297(24):2697-704. doi: 10.1001/jama.297.24.2697.