Sedentary Behavior in African Americans | NCT00907465

Studies
Sedentary Behavior in African Americans

NCT00907465

Sponsor

Pennington Biomedical Research Center

Status

Completed

Last Update Posted

Dec 4, 2012Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Cardiovascular Disease

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
1K01HL088723-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2012

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

Jul 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

May 18, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 22, 2009Estimated

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

Dec 2, 2012

Last Update Posted Date

Dec 4, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Newton, Principal Investigator, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 study is designed to develop methods for objectively measuring sedentary behavior, assess the association between objectively measured sedentary behavior and cardiovascular disease outcomes, and develop an intervention to reduce sedentary behavior, in African American adults.

Detailed Description

Not provided

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

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Calibration study		These individuals were used to develop cut points for sedentary behavior using accelerometers and a metabolic chamber.

Interventions

Not provided

Measure	Description	Time Frame
Sedentary behavior		2009-2010

Measure	Description	Time Frame
Blood pressure		2009-2010
High density lipoproteins		2009-2010

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

self-classify yourself as African American
are aged 18 years or older
are free of serious medical condition, such as cancer, cardiovascular disease, or emphysema.
are free of serious medical conditions that would prevent participant from engaging in physical activity.
are willing to have a scan completed that measures your body composition
are willing to stay in metabolic chamber for 8.5 hours (8:00am until 4:30 pm)
are willing to wear an accelerometer for 2, one-week periods following your chamber stay. There will be one week in-between the 2, one-week periods.
are willing to complete questionnaire related to your level of activity
weigh less than 250 lbs.

Exclusion Criteria:

unwilling or unable to perform activities in protocol
on medications
a woman who is intending to become pregnant, or who is pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Community members of Baton Rouge, LA.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert L Newton, Ph.D.	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided