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Tracking Information | |||||
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First Received Date ICMJE | April 10, 2003 | ||||
Last Updated Date | April 22, 2008 | ||||
Start Date ICMJE | March 2003 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00058669 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | CVD Risk Factors and Sexual Identity in Women | ||||
Official Title ICMJE | |||||
Brief Summary | To examine potential differences in the prevalence and pattern of risk factors for coronary heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women, matched for age, socioeconomic status, and ethnicity. |
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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. |
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Study Phase | N/A | ||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | |||||
Condition ICMJE |
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Intervention ICMJE | |||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | |||||
Completion Date | February 2008 | ||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | No eligibility criteria |
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00058669 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | 1210 | ||||
Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
Verification Date | April 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |