Diet and Exercise in Overweight Children Postburn

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Michele Gottschlich, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00537160
First received: September 27, 2007
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Obesity
Burns
Behavioral: Behavior modification, Nutrition Education, Exercise
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

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

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

Enrollment: 0
Study Start Date: April 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537160

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

No publications provided

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
Study First Received: September 27, 2007
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Pediatrics

Additional relevant MeSH terms:
Burns
Obesity
Overweight
Wounds and Injuries
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014