Diet and Exercise in Overweight Children Postburn

Early Phase 1

Withdrawn

• Conditions: Obesity; Burns

• Registration Number: NCT00537160
• Lead Sponsor: Shriners Hospitals for Children

Brief Summary

Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-09-28
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 10-18 years old
• BMI > or = 95th percentile
• > 1 year postburn and out of pressure garments
• Live within 100 minle radius of SHC
• Informed consent and HIPPA form signed
• Parent/guardia willing to make time commitment

Exclusion Criteria

• Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame
• Physical/health condition that precludes regular exercise
• Significant mental health diagnosis
• Advised by MD not to exercise
• Thyroid disease, routine steroid use,pregnancy
• Unable to understand the instructions/content of program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
BMI	12 and 24 months following intervention

Secondary Outcome Measures

Name	Time	Method
fitness level	12 and 24 months following intervention