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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409422
• Other study ID #: HIC 15994
• Status: Completed
• Phase: N/A
• First received: December 6, 2006
• Last updated: June 20, 2008
• Start date: May 2002
• Est. completion date: February 2007

Study information

• Verified date: June 2008
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperinsulinemia
• Hyperinsulinism
• Insulin Resistance
• Pediatric Obesity

Intervention

Behavioral:
• weight management program

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight		6 months and 1 year
Primary	body mass index		6 months and 1 year
Primary	% body fat		6 months and 1 year
Primary	lipids		6 months and 1 year
Primary	blood pressure		6 months and 1 year
Primary	glucose		6 months and 1 year
Primary	insulin		6 months and 1 year
Primary	HOMA index		6 months and 1 year
Secondary	planned to compare dieting with non-dieting approach in weight management group		6 months and 1 year