Diet and Exercise in Overweight Children Postburn

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00537160
• Other study ID #: 06-04-26-01
• Status: Withdrawn
• Phase: Phase 0
• First received: September 27, 2007
• Last updated: October 25, 2012
• Start date: April 2006
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Obesity

Intervention

Behavioral:
• Behavior modification, Nutrition Education, Exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		12 and 24 months following intervention
Secondary	fitness level		12 and 24 months following intervention