Validation and Evaluation of a Portable Body Scanner for... | NCT01049269

Studies
Validation and Evaluation of a Portable Body Scanner for Determination of Obesity

NCT01049269

Sponsor

University of Texas at Austin

Status

Completed

Last Update Posted

Jun 25, 2015Estimated

Enrollment

180Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
5R21DK081206	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jan 13, 2010

First Submission Date that Met QC Criteria

Jan 13, 2010

First Posted Date

Jan 14, 2010Estimated

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

Jun 23, 2015

Last Update Posted Date

Jun 25, 2015Estimated

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

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

The objective of this study is to validate a portable 3D human body measurement system which will improve approaches in obesity assessment.

Detailed Description

Obesity has become an epidemic in the United States. A new technique of three-dimensional (3 D) photonic scanning will be used to create and validate a portable instrument that rapidly assesses obesity in clinical and field settings. This new portable body scanner will be a safe and easy method to help determine the incidence and type of obesity.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Label	Type	Description	Intervention Names
1:one group

Measure	Description	Time Frame
Body volume		3 hours

Measure	Description	Time Frame
Validating body imaging as an indicator of central obesity		3 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-60 years old
BMI between 18.50 to 39.99 kg/m3
Free of known diseases
Hispanic and Not Hispanic or Latino Whites

Exclusion Criteria:

Women who are pregnant, could be pregnant, or lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Subject will be 18-60 years old, BMI 18.50 to 39.99 kg/m3, and free of known diseases, who are Hispanic and Not Hispanic or Latino Whites.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeanne H. Freeland-Graves, Ph.D.	The University of Texas at Austin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Uniersity of Texas at Austin		Austin	Texas	78712	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided