Cardiovascular DiseasesNCT00005386
Biobehavioral Determinants of Obesity in Black Women
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Memphis.
Trial summary
To examine the biobehavioral determinants of obesity in Black as compared with white women. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1995to Aug 1998
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine the biobehavioral determinants of obesity in Black as compared with white women.
Read the detailed description
BACKGROUND:
Behavioral medicine surveys consistently find that obesity is a treatment-resistant disease that continues to be a significant health problem and that the incidence of obesity is much higher in Blacks relative to whites in general, and even higher in Black women relative to white women. In fact, an NIH Program Announcement (PA-91-99), stated that "Obesity in adults has not declined in the past three decades" and "Obesity is particularly prevalent in minority populations, especially among minority women." Obesity is an independent risk factor for cardiovascular disease, stroke, and hypertension. Obesity is a complex phenomenon involving behavioral, lifestyle, and complex biobehavioral mechanisms. In 1995, there were no prospective studies that simultaneously evaluated a systematic set of psychosocial variables with energy balance (dietary intake, physical activity, resting metabolic rate) determinants that may account for the increased risk for obesity in African-American versus Euro-American women.
DESIGN NARRATIVE:
After subjects were recruited, psychosocial and energy balance (dietary intake, physical activity, metabolic rate) baseline measures were related to levels of body fat as measured by DEXA (dual electron X-ray absorptiometry). The role of these variables were evaluated prospectively to adiposity changes in both white and Black women over a 24-month period.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Telangiectasis
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity, Telangiectasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1995
- Study completionAug 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Robert Klesges, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005386
- Sponsor's protocol ID
- 4292
- Other IDs
- R01HL053261
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 28 Jan 2016
- Results posted
- No
Publications
Scarinci IC, Slawson DL, Watson JM, Klesges RC, Murray DM. Socioeconomic status, ethnicity, and health care access among young and healthy women. Ethn Dis. 2001 Winter;11(1):60-71.
PubMed 11289253Scarinci IC, Watson JM, Slawson DL, Klesges RC, Murray DM, Eck-Clemens LH. Socioeconomic status, ethnicity, and environmental tobacco exposure among non-smoking females. Nicotine Tob Res. 2000 Nov;2(4):355-61. doi: 10.1080/713688150.
PubMed 11197316
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Determinants of Obesity in Black Women
- ClinicalTrials.gov ID
- NCT00005386
- Acronym / sponsor ID
- 4292
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity, Telangiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1995
- Study completion
- Aug 1998
- First posted
- 26 May 2000 (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.
To examine the biobehavioral determinants of obesity in Black as compared with white women.
Detailed description
BACKGROUND:
Behavioral medicine surveys consistently find that obesity is a treatment-resistant disease that continues to be a significant health problem and that the incidence of obesity is much higher in Blacks relative to whites in general, and even higher in Black women relative to white women. In fact, an NIH Program Announcement (PA-91-99), stated that "Obesity in adults has not declined in the past three decades" and "Obesity is particularly prevalent in minority populations, especially among minority women." Obesity is an independent risk factor for cardiovascular disease, stroke, and hypertension. Obesity is a complex phenomenon involving behavioral, lifestyle, and complex biobehavioral mechanisms. In 1995, there were no prospective studies that simultaneously evaluated a systematic set of psychosocial variables with energy balance (dietary intake, physical activity, resting metabolic rate) determinants that may account for the increased risk for obesity in African-American versus Euro-American women.
DESIGN NARRATIVE:
After subjects were recruited, psychosocial and energy balance (dietary intake, physical activity, metabolic rate) baseline measures were related to levels of body fat as measured by DEXA (dual electron X-ray absorptiometry). The role of these variables were evaluated prospectively to adiposity changes in both white and Black women over a 24-month period.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 28 Jan 2016.
- Background: PubMed 11289253Scarinci IC, Slawson DL, Watson JM, Klesges RC, Murray DM. Socioeconomic status, ethnicity, and health care access among young and healthy women. Ethn Dis. 2001 Winter;11(1):60-71.
- Background: PubMed 11197316Scarinci IC, Watson JM, Slawson DL, Klesges RC, Murray DM, Eck-Clemens LH. Socioeconomic status, ethnicity, and environmental tobacco exposure among non-smoking females. Nicotine Tob Res. 2000 Nov;2(4):355-61. doi: 10.1080/713688150.
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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 Klesges
University of Memphis
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Memphis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005386, which also lists 2 linked publications.
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 28 Jan 2016.