- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00058669
CVD Risk Factors and Sexual Identity in Women
Study Overview
Status
Detailed Description
BACKGROUND:
Coronary heart disease (CHD) is the leading cause of mortality among women living in the United States, regardless of race and ethnicity and is likely the leading cause of mortality among lesbians. However, in various reports since 1994, the National Institute of Mental Health, the Centers for Disease Control and Prevention, the American Medical Association, the American Public Health Association, and the Institute of Medicine (IOM) have pointed out that health care and health research affecting lesbian women are inadequate. As women, lesbians share many of the same health concerns of all women. However, as emphasized in the IOM Report on Lesbian Health "factors assumed to place women at risk for or to protect them against health disorders may not be present at the same levels or operate in the same way for lesbians". The IOM report also recognizes that "women who self-identify as lesbian may also experience stressors not commonly faced by heterosexual women" and that "it is important to understand the factors that are unique to lesbians and their impact on lesbians' health". Data which do exist from household surveys and studies utilizing convenience samples indicate that women who identify as lesbian may differ from heterosexual women in several important factors which contribute to the development of CHD. However, to date there has not been a comprehensive examination of CHD risk in a large sample of women who identify as lesbian or an examination of how their pattern of risk factors or overall risk for CHD may differ from a sample of demographically similar heterosexual women.
DESIGN NARRATIVE:
The study is a case-control, cross-sectional survey that includes both behavior (alcohol, smoking, substance use, physical activity) and physiological (lipids, blood pressure, adiposity) measures. Self-identified lesbian women will be age, education, and racially matched to heterosexual women. The study will test the hypotheses that the prevalence and pattern of coronary heart disease (CHD) risk factors are different between lesbians and heterosexual women. The study will also determine the absolute and relative risk estimates for CHD based on the Framingham multiple-risk-factor assessment equations, and test the hypothesis that lesbians are at increased risk of CHD compared to heterosexual women.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
risk of cardiovascular disease
Time Frame: single visit
|
Framingham risk profile
|
single visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: nina markovivc, phd, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1210
- R01HL067052 (U.S. NIH Grant/Contract)
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