Diet and Exercise in Overweight Children Postburn

NCT ID: NCT00537160

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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Conditions

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Obesity Burns

Keywords

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Pediatrics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Behavior modification, Nutrition Education, Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

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Michele Gottschlich

Research Dietitian

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele M Gottschlich, PhD, RD, CNSD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospital for Children

Other Identifiers

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06-04-26-01

Identifier Type: -

Identifier Source: org_study_id