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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014