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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Pediatric Obesity; Hyperinsulinemia
• Intervention / Treatment: Behavioral: weight management program

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 Type: Interventional
• Enrollment: 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
planned to compare dieting with non-dieting approach in weight management group	6 months and 1 year

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Sonia Caprio, MD, Yale University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: December 6, 2006
• First Submitted That Met QC Criteria: December 6, 2006
• First Posted (Estimate): December 8, 2006

Study Record Updates

• Last Update Posted (Estimate): June 24, 2008
• Last Update Submitted That Met QC Criteria: June 20, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: overweight; insulin resistance; pediatric obesity; hyperinsulinemia; family-based; weight management program
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Insulin Resistance; Hyperinsulinism
• Other Study ID Numbers: HIC 15994