Diet and Exercise in Overweight Children Postburn | NCT00537160

Studies
Diet and Exercise in Overweight Children Postburn

NCT00537160

Sponsor

Shriners Hospitals for Children

Status

Withdrawn

Last Update Posted

Oct 29, 2012Estimated

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Obesity
Burns

Interventions

Behavior modification, Nutrition Education, Exercise

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Sep 27, 2007

First Submission Date that Met QC Criteria

Sep 27, 2007

First Posted Date

Sep 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2012

Last Update Posted Date

Oct 29, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele Gottschlich, Research Dietitian, Shriners Hospitals for ChildrenPrincipal Investigator

Lead Sponsor

Shriners Hospitals for ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Behavior modification, Nutrition Education, Exercise	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BMI		12 and 24 months following intervention

Secondary Outcomes

Measure	Description	Time Frame
fitness level		12 and 24 months following intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele M Gottschlich, PhD, RD, CNSD	Shriners Hospital for Children	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D002056	Burns

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001521	Behavior Therapy
D015596	Nutrition Assessment
D015444	Exercise

Ancestor Terms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities
D003625	Data Collection
D004812	Epidemiologic Methods

Browse Leaves

Not provided

Browse Branches

Not provided