NCT00537160WithdrawnEarly Phase 1
The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation
Conditions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Withdrawn
- Primary Endpoint
- BMI
Study Overview
Brief Summary
Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
BMI
Time Frame: 12 and 24 months following intervention
Secondary Outcomes
- fitness level(12 and 24 months following intervention)
Investigators
Michele Gottschlich
Research Dietitian
Shriners Hospitals for Children
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