Diet and Exercise in Overweight Children Postburn - Full Text View

Diet and Exercise in Overweight Children Postburn

This study is not yet open for participant recruitment.
Verified by Shriners Hospitals for Children, September 2007

Sponsored by:	Shriners Hospitals for Children
Information provided by:	Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00537160

Purpose

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

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

MedlinePlus related topics:

Burns Exercise and Physical Fitness Obesity Obesity in Children Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation

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 ]

Estimated Enrollment:	10
Estimated Study Completion Date:	January 2011

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

Study ID Numbers:	06-04-26-01
First Received:	September 27, 2007
Last Updated:	September 27, 2007
ClinicalTrials.gov Identifier:	NCT00537160
Health Authority:	United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:

Pediatrics

Study placed in the following topic categories:

Body Weight

Burns

Signs and Symptoms

Obesity

Nutrition Disorders

Overnutrition

Overweight

ClinicalTrials.gov processed this record on October 24, 2008