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

NCT ID: NCT00409422

Last Updated: 2008-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2007-02-28

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).

Conditions

Pediatric Obesity; Insulin Resistance; Hyperinsulinemia

Keywords

pediatric obesity; overweight; insulin resistance; hyperinsulinemia; weight management program; family-based

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

weight management program

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Yale University School of Medicine

Principal Investigators

Sonia Caprio, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 17595270 (View on PubMed)

Other Identifiers

HIC 15994

Identifier Type: -

Identifier Source: org_study_id