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Diet and Exercise in Overweight Children Postburn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00537160
Recruitment Status : Withdrawn
First Posted : September 28, 2007
Last Update Posted : October 29, 2012
Information provided by (Responsible Party):
Michele Gottschlich, 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.

Condition or disease Intervention/treatment Phase
Obesity Burns Behavioral: Behavior modification, Nutrition Education, Exercise Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation
Study Start Date : April 2006
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. BMI [ Time Frame: 12 and 24 months following intervention ]

Secondary Outcome Measures :
  1. fitness level [ Time Frame: 12 and 24 months following intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537160

Sponsors and Collaborators
Shriners Hospitals for Children
Principal Investigator: Michele M Gottschlich, PhD, RD, CNSD Shriners Hospital for Children

Responsible Party: Michele Gottschlich, Research Dietitian, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00537160     History of Changes
Other Study ID Numbers: 06-04-26-01
First Posted: September 28, 2007    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by Michele Gottschlich, Shriners Hospitals for Children:

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms