What was the Women's Health
The Women's Health Initiative (WHI) was a long-term national
health study that focused on strategies for preventing heart disease, breast
and colorectal cancer and osteoporosis in postmenopausal women. These chronic
diseases are the major causes of death, disability and frailty in older women
of all races and socioeconomic backgrounds.
This multi-million dollar, 15-year project, sponsored by the
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute
(NHLBI), involved 161,808 women aged 50-79, and was one of the most
definitive, far reaching clinical trials of women's health ever undertaken in
the U.S. The WHI Clinical Trial and Observational Study attempted to address
many of the inequities in women's health research and provide practical
information to women and their physicians about hormone therapy,
dietary patterns and calcium/vitamin D supplements, and their effects on the
prevention of heart disease, cancer and osteoporosis.
A Community Prevention Study (CPS), a 5-year cooperative
venture with CDC, was a study of strategies to enhance adoption of healthful
behaviors through a multi-disciplinary approach. The purpose of the CPS
develop community-based public health interventions models which would achieve
healthful behaviors in women aged 40 and over.
A New Era in Women's Health: the Women's
To respond to the crucial need for the involvement of women
in medical research, the NIH in 1990 established the Office of Research on
Women's Health (ORWH). The earliest undertakings of the ORWH included the
development of a research agenda to identify and address gaps in the biomedical
community's knowledge of women's health and the strengthening and
revitalization of already existing NIH guidelines and policies for the
inclusion of women and minorities in clinical studies.
With the growing scientific interest in research on women's
health, Dr. Bernadine Healy, then director of the NIH, launched WHI in April
How was WHI conducted?
The WHI study had three components: a randomized clinical
trial, an observational study, and a community prevention study.
The randomized controlled clinical trial (CT) enrolled
68,132 postmenopausal women between the ages of 50-79. The clinical trial
had three study components. If eligible, women could choose to enroll in one,
two, or all three of the components. The components were:
- Hormone Therapy (HT): This component
examined the effect of HT on the prevention of heart disease and
osteoporosis, and any associated risk for breast cancer. Women participating in
this component took hormone pills or a placebo (inactive pill).
- Dietary Modification: The Dietary Modification
component evaluated the effect of a low-fat, high fruit, vegetable and
grain diet on the prevention of breast and colorectal cancer and heart disease.
Study participants followed either their usual eating pattern or a low-fat eating
- Calcium/Vitamin D: This component started up to 2
years after a woman joined one or both of the other studies. It evaluated
the effect of calcium and vitamin D supplementation on the prevention of
osteoporosis-related fractures and colorectal cancer. Women in this component
took calcium and vitamin D pills or a placebo.
The observational study (OS) examined the relationship
between lifestyle, health and risk factors and specific disease outcomes. This
component tracked the medical history and health habits of approximately
Recruitment for the observational study was completed in
1998 and participants were followed for 8 to 12 years.
The community prevention study (CPS) was a unique
collaborative venture between the Centers for Disease Control and Prevention
(CDC), and the National Institutes of Health. Eight University-based Prevention
Centers underwritten by CDC conducted and evaluated health programs that
encouraged women of all races and socioeconomic backgrounds to adopt healthful
behaviors such as improved diet, nutritional supplementation, smoking
cessation, exercise and early detection of treatable health problems. The goal
of the community prevention study was to develop carefully evaluated, model
programs that could be implemented in a wide range of communities throughout the
U.S. For additional information on the CPS, please contact Ms. Patricia Riley
at (770) 488-5395.
Where Did the WHI CT/OS Take Place?
The WHI clinical trial and observational study was
conducted at 40 clinical centers nationwide. The Fred Hutchinson Cancer
Research Center in Seattle, WA served as the WHI Clinical Coordinating Center
for data collection, management, and analysis. Recruitment began in September
1993 and continued through December 1998 for those women who chose to "be part of
Study participants got the personal satisfaction of knowing
that they were contributing to their own health and the health of women for
generations to come.