The Women's Health Initiative: A Landmark National Health Effort

Helping generations of women: Alva Torres (left), believes her time with the Women's Health Initiative will benefit her daughters and grandchildren most." At the onset, many predicted a study of this scope wouldn't be possible. The tremendous participation is an incredible statement by the women of our nation."

In March 1993, the College of Medicine was selected by the National Institutes of Health as one of the initial 16 "Vanguard Clinical Centers" for the Women's Health Initiative. Since then, the UA's $14 million, 12-year study has opened two offices (one in Tucson and one in Phoenix), has enrolled thousands of women participants, and has played a vital role in ensuring Hispanic, Native American and older women are represented in this landmark national effort.

The NIH-funded Women's Health Initiative seeks to learn how diet, hormone therapy and calcium and vitamin D might prevent heart disease, cancer, bone degeneration and memory loss - the major causes of death, disability and frailty in older women. The first study to examine the health of a very large number of mature women over a long period of time, the study aims to redress many of the inequities in women's health research.

"Historically, women's health has not been adequately studied," says principal investigator Cheryl Ritenbaugh, Ph.D., M.P.H. "And too many studies in the past have not included members of minority groups. The Arizona clinical center is one of only four in the nation focusing on the enrollment of Hispanic women - and is the only center focusing on the enrollment of Native American women," she says, adding that about 40 percent of the Arizona participants will be from the Hispanic and Native American populations. Nationally, 24 additional clinical centers were established in 1995.

To date, the Arizona effort has enrolled more than 3,600 women. Although the dietary portion of the study has reached capacity in Tucson, an additional 900 women, aged 50-79, still are being recruited to various portions of the study at both clinics.

"The women participating in this study are amazing," Ritenbaugh says. "They are taking part in this long-term effort for the sake of future generations - for their daughters and granddaughters."

Study participant and native Tucsonan Alva Torres explains that when she heard about the Women's Health Initiative, "I thought, what a great way to make a real difference for our grandchildren and great-grandchildren. That is when the benefits of research will be reaped. Our grandmothers gave us benefits by passing on our traditional beliefs and teaching us about folk medicines and good nutrition. We owe it to our future generations to pass on something positive."

A major challenge is to reach the minority women who are so important to the study's success. "Unfortunately, minority women never have been recruited for large-scale studies, so an important part of our effort is to learn the most effective ways to reach these women," Ritenbaugh points out. The study recently received a federal grant to develop a recruitment model for minority populations. "Recruitment largely has been through extensive community outreach. We have given talks about the study in every possible venue."

Theresa G. Montano, a retired registered nurse and study participant, has helped spread the word about the study throughout the Hispanic community. "I've been on radio, TV and have spoken to a number of Hispanic organizations," she says. "I found that many Hispanic women were unaware of this study, but once they learn about the Women's Health Initiative they become very interested."

Ritenbaugh adds that following the study's intense community outreach efforts, minority women now are beginning to respond to mass mailings as well. Because of our state's large retirement population, the Arizona study also specifically is seeking older women, ages 70-79. "And we're leading the nation in recruitment of women in that age group," Ritenbaugh says.

Nationally, this $628 million, 15-year project will involve 164,500 women, ages 50-79, from more than 40 communities. The project is divided into two components - an observational study and three clinical trials. The observational study, which will involve 100,000 women, will follow participants for an average of nine years. The data gathered will be used to improve risk estimates for cardiovascular disease, diabetes, cancer and bone fractures in postmenopausal women. Today, those risk factors are poorly quantified or unknown.

At the same time, the clinical trials will follow 64,500 women for nine years to determine the benefits and risks of hormone-replacement therapy, dietary modification and calcium and vitamin D supplementation on the overall health of postmenopausal women.

"To undertake a study in which you are looking at disease outcomes - not just risk factors - requires a tremendous number of participants and a lot of time," Ritenbaugh explains. "The only way to make this study possible financially was for large numbers of women to come forward and participate without compensation - and that is exactly what has happened."

Montano, who has three daughters and three granddaughters, adds, "I believe this study is extremely important for our children and grandchildren. Participating doesn't take much time; the tests are terrific and the staff makes you feel at ease - you always feel welcome."