Cardiovascular DiseaseSeBANCT00907465
Sedentary Behavior in African Americans
An observational study of Cardiovascular Disease, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community members of Baton Rouge, LA.
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- unwilling or unable to perform activities in protocol
- on medications
- a woman who is intending to become pregnant, or who is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Measurement of Sedentary Behavior in African American Adults
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.
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Calibration study | These individuals were used to develop cut points for sedentary behavior using accelerometers and a metabolic chamber. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary behavior
Measured: 2009-2010
Secondary outcomes (2)
Blood pressure
Measured: 2009-2010
High density lipoproteins
Measured: 2009-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Newton, Pennington Biomedical Research Center
- Investigators
- Robert L Newton, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907465
- Sponsor's protocol ID
- PBRC 27013
- Other IDs
- 1K01HL088723-01
- Acronym
- SeBA
- Status last verified
- Dec 2012
- First submitted
- 18 May 2009
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Sedentary Behavior in African American Adults
- ClinicalTrials.gov ID
- NCT00907465
- Acronym / sponsor ID
- SeBA / PBRC 27013
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calibration study | – | –These individuals were used to develop cut points for sedentary behavior using accelerometers and a metabolic chamber. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community members of Baton Rouge, LA.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- unwilling or unable to perform activities in protocol
- on medications
- a woman who is intending to become pregnant, or who is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sedentary behavior
Time frame: 2009-2010
2 secondary outcomes
Blood pressure
Time frame: 2009-2010
High density lipoproteins
Time frame: 2009-2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Newton, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedentary behavior (time frame: 2009-2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.