ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Tuesday, May 14, 1996 TAG: 9605140016
SECTION: EXTRA PAGE: 6 EDITION: METRO
COLUMN: Personal Health
SOURCE: JANE BRODY
``The women of America need you'' might well be the slogan that Barbara Halweg and nearly 55,000 others have already heeded.
And they are looking for another 109,500 women from 50 to 79 to join their ranks as participants in the Women's Health Initiative, the largest series of prevention studies ever undertaken to determine how to protect the health of women as they age.
Halweg, a 69-year-old housewife from Edina, a suburb of Minneapolis, is proud to be one of the subjects in this history-making study, which may eventually result in a healthier old age for present and future generations of women.
The initiative, a $628 million, 15-year project sponsored by the National Institutes of Health, is trying to make up for the decades of research focused exclusively or primarily on men. Can those findings be applied to women? Maybe yes, but maybe not.
``So few bits of research have been done on women,'' Halweg said in an interview, echoing the sentiments of Dr. Bernadine Healy, the former National Institutes of Health director who started the initiative in 1991 to help fill in the gender-based research gaps. ``The bodies of men and women are different,'' Halweg continued. ``They function differently and the effects of what they eat are likely to be different.''
Three separate clinical trials, involving 64,500 women, are seeking to determine what contributions a diet low in fat and rich in produce, hormone replacement therapy after menopause and supplements of calcium and vitamin D can make to the health of older women.
A second arm of the initiative, an observational study involving 100,000 women, will try to ferret out physiological clues that can predict future disease in women.
A third part, the Community Prevention Study, done in collaboration with the federal Centers for Disease Control and Prevention, will focus on developing strategies to promote healthful behaviors among women of all races and socioeconomic backgrounds.
The study is especially eager to enroll women in minority and low-income groups, who have historically lagged behind white, affluent women in adopting healthful eating and exercise habits and in taking advantage of early detection techniques.
``There are lots of unanswered questions,'' said Dr. Loretta Finnegan, the director of the overall initiative. She readily admits that a woman who participates might not live long enough to benefit directly from the answers. But each participant, she said, ``will help us find out important things that can benefit her daughters, granddaughters and future generations.''
Then she added a sobering note: ``If this study fails to recruit enough women to meet our end points, this will be a sad time for women. We will have failed to show Congress that its enormous commitment to research on women was worthwhile, and we are not likely to be given a second chance.''
Every participant will have an opportunity to have her health monitored at government expense. She will receive information about her current health status and counseling on how to delay its deterioration. Participants in the clinical trials will be randomly assigned by computer to receive either the experimental regimen or standard care.
For example, Halweg, one of 48,000 women expected to participate in the diet-modification trial, was randomly chosen to be in the experimental group. Her goals are to reduce her fat intake to 20 percent of her daily caloric intake and to eat five or more servings of fruits and vegetables and six or more servings of grains each day.
``I thought my husband and I were eating a pretty healthy diet before I joined the study,'' she said. ``We've always eaten a lot of fruits and vegetables. But after keeping a diary of everything I ate for five days and having the fat content analyzed, I was astounded to find out how much fat we were eating that I hadn't taken into account.''
With the help of nutrition counseling, shopping and cooking tips and some ``delicious'' recipes supplied by the study, she said she had learned to eat and enjoy meals far lower in fat. ``Even my husband has commented that we're having some interesting meals,'' she said.
The researchers want to know whether the modified diet will help to prevent heart disease and breast and colorectal cancers. Every six months, researchers will assess the health of participants, who are asked to keep periodic food diaries to be sure they are still following the recommended diet and to assess changes women in the control group may be making on their own.
About 27,500 postmenopausal women are being recruited for the hormone replacement study. They will be randomly assigned to receive estrogen and progestin (if they have a uterus) or estrogen alone (for women who have had a hysterectomy) or a placebo.
For the next 8 to 12 years they will be checked every six months at a clinic to assess their health status and make sure they are experiencing no ill effects from the assigned treatment. The goal of the study is to determine whether long-term treatment with postmenopausal hormones can reduce heart disease and fractures without increasing the risk of breast cancer.
Although other studies have hinted at benefits, and possible risks, of hormone treatment, there have been no clinical trials that could clearly define the health value of postmenopausal hormones irrespective of a woman's other health habits.
All long-term studies to date have involved women who had chosen to take hormones, and such women are known to be more health-conscious than average, which could account for the suggested benefits.
A third trial (and many women will be invited to participate in more than one) is investigating the effect of calcium and vitamin D supplements on bone fractures and on the risk of developing colorectal cancer.
Half of the 45,000 participants will be randomly assigned to take either 1,000 milligrams of calcium carbonate and 400 International Units of vitamin D or a placebo each day for eight to 11 years. They, too, will be questioned by health professionals every six months.
Participants in the observational study, who will not have to change their habits or take any medication, will be helping researchers determine the most reliable risk factors in predicting heart disease, cancers and fractures in older women, and perhaps also help identify factors not yet known.
The women themselves will be tracked for an average of nine years, but for decades thereafter their stored blood will provide a valuable resource for identifying future biological indicators of disease.
Forty clinical centers throughout the country are participating in the Women's Health Initiative. If you live anywhere near one, you too can become a part of history by calling (800) 54-WOMEN (549-6636); you will be connected to a participating clinical center in your area.
LENGTH: Long : 117 linesby CNB