Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
Primary Purpose
Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight management program
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring pediatric obesity, overweight, insulin resistance, hyperinsulinemia, weight management program, family-based
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
Sites / Locations
- Yale University School of Medicine
Outcomes
Primary Outcome Measures
weight
body mass index
% body fat
lipids
blood pressure
glucose
insulin
HOMA index
Secondary Outcome Measures
planned to compare dieting with non-dieting approach in weight management group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00409422
Brief Title
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
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
Keywords
pediatric obesity, overweight, insulin resistance, hyperinsulinemia, weight management program, family-based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
weight management program
Primary Outcome Measure Information:
Title
weight
Time Frame
6 months and 1 year
Title
body mass index
Time Frame
6 months and 1 year
Title
% body fat
Time Frame
6 months and 1 year
Title
lipids
Time Frame
6 months and 1 year
Title
blood pressure
Time Frame
6 months and 1 year
Title
glucose
Time Frame
6 months and 1 year
Title
insulin
Time Frame
6 months and 1 year
Title
HOMA index
Time Frame
6 months and 1 year
Secondary Outcome Measure Information:
Title
planned to compare dieting with non-dieting approach in weight management group
Time Frame
6 months and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Caprio, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17595270
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.
Results Reference
derived
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Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children
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