Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)
Data Collection
Collected from today forward - ProspectiveBehavior+8
+ Behavioral Symptoms
+ Brain Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 1, 1983
Actual date on which the first participant was enrolled.BACKGROUND: In 1983, when the Healthy Women Study began, there was a paucity of epidemiological studies of cardiovascular risk factor changes and risk of heart disease related to natural menopause. The Healthy Women Study was one of the few in which the status of premenopausal women was followed carefully through and subsequent to the menopause. The study also included detailed behavioral and biological measures, as well as important environmental factors related to the determinants of these risk factors. DESIGN NARRATIVE: A cross-sectional study was conducted to determine the relationship between risk factors, behavioral, psychosocial, and other environmental determinants. A five year longitudinal follow-up of the women evaluated changes over time in risk factors related to the perimenopausal and postmenopausal periods. Longitudinal follow-up after the menopause continues in order to determine the relationships among changes in behavior, hormones, habits, and risk factors. The women had home interviews, baseline examinations, follow-up of menstrual cycles, and a six-month self-administered questionnaire. Risk factors studied included behavioral factors, glucose and insulin, obesity, exercise, cigarette smoking, nutrition, lipoproteins, blood pressure, and hormones. Surgical menopause and the use of exogenous hormones were also studied. Although not part of the original protocol, measurements of fat distribution, coagulation factors, apoproteins, sodium-lithium counter-transport, and sodium-hydrogen exchange in platelets were added. The study was renewed in 1995 to continue follow-up to determine characteristics of changes in risk factors, behavioral/psychological attributes and to determine the relationship between risk factors, and their changes and atherosclerotic plaque and wall thickness. Studies are conducted on the interrelationship of lifestyle and behavioral attributed to sex-steroid hormones and insulin and the level of hormones to atherosclerosis. A determination is made of the association of lifestyle to amount and distribution of body fat measured by DEXA and CT of the abdomen. The study has been renewed several times and ends in November of 2007.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.532 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 20 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion criteria: Women had to be premenopausal and have an intact uterus and ovaries Exclusion criteria: hypertension, diabetes, heart disease, major cancer or stroke
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives