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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00409422
Other study ID # HIC 15994
Secondary ID
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


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
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