NCT00907465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

May 18, 2009

Last Update Submit

December 2, 2012

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Sedentary behavior

    2009-2010

Secondary Outcomes (2)

  • Blood pressure

    2009-2010

  • High density lipoproteins

    2009-2010

Study Arms (1)

Calibration study

These individuals were used to develop cut points for sedentary behavior using accelerometers and a metabolic chamber.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community members of Baton Rouge, LA.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Robert L Newton, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 22, 2009

Study Start

July 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations

US(1)