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Diet and Exercise in Overweight Children Postburn

Primary Purpose

Obesity, Burns

Status

Withdrawn

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Behavior modification, Nutrition Education, Exercise

About this trial

This is an interventional treatment trial for Obesity focused on measuring Pediatrics

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All Sexes

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

Sites / Locations

Outcomes

Primary Outcome Measures

BMI

Secondary Outcome Measures

fitness level

Full Information

NCT ID

NCT00537160

First Posted

September 27, 2007

Last Updated

October 25, 2012

Sponsor

Shriners Hospitals for Children

1. Study Identification

Unique Protocol Identification Number

NCT00537160

Brief Title

Diet and Exercise in Overweight Children Postburn

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Withdrawn

Study Start Date

April 2006 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Burns

Keywords

Pediatrics

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Behavior modification, Nutrition Education, Exercise

Primary Outcome Measure Information:

Title

BMI

Time Frame

12 and 24 months following intervention

Secondary Outcome Measure Information:

Title

fitness level

Time Frame

12 and 24 months following intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michele M Gottschlich, PhD, RD, CNSD

Organizational Affiliation

Shriners Hospital for Children

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Diet and Exercise in Overweight Children Postburn

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