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NHLBI Study Tests Novel Ways to Help Americans Keep Weight Off

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Duke Health News 919-660-1306

The National Heart,
Lung, and Blood Institute
(NHLBI) today announced the
launch of a major study that could help solve one of the
hardest aspects of weight loss -–keeping off lost pounds. The
study, called the "Weight Loss Maintenance Trial," will be done
in two phases at four clinical sites.

The study will include 1,600 men and women in its first
phase, and 800 in its second. Phase I is a five-month weight
loss program; phase II will try to help those who lose nine or
more pounds in phase I keep the weight off for 2½ years.

The study has begun seeking participants, who must be
overweight or obese, age 25 or older, and taking medication to
control high blood pressure and/or high blood cholesterol.
About 60 percent will be women and 40 percent will be African
American.

"Maintaining weight loss is a critical element in the
struggle against overweight and obesity, which have reached
epidemic proportions in the United States," said NHLBI Director
Claude Lenfant, M.D. "Two of every three adults are overweight
or obese. This study could yield answers that can help many
Americans lead healthier lives."

"Americans have shown that they can lose weight in the
short-term," said Laura Svetkey, M.D., director of the Duke
Hypertension Center and of Clinical Research at the Sarah
Stedman Nutrition and Metabolism Center at Duke University
Medical Center in Durham, N.C., and lead investigator in the
study. "Yet, only a small proportion of them achieve long-term
weight control. To successfully fight the obesity epidemic,
clinicians and other health care providers must have options
that are effective and feasible for a broad range of
people.

"The best weight-loss strategy will not only lead to
long-term weight control, but also achieve it by establishing a
healthy dietary pattern and physical activity routine that
lasts a lifetime," she added.

Overweight/obesity is the second leading cause of
preventable death in the United States. Overweight and obesity
increase the risk of heart disease and other conditions,
including high blood pressure, high blood cholesterol,
diabetes, stroke and some cancers.

About 65 percent of American adults -– about 129 million
persons –- are overweight or obese, and the prevalence is
increasing. In 1988-94, almost 60 percent of American adults
were overweight or obese, while in 1999-2000, nearly 65 percent
were overweight or obese.

The four centers involved in the Weight Loss Maintenance
study are: Duke University Medical Center; Pennington
Biomedical Research Center at Louisiana State University in
Baton Rouge; Kaiser Permanente Center for Health Research
(KPCHR) in Portland, Ore.; and The Johns Hopkins Medical
Institutions in Baltimore, Md. KPCHR also serves as the study's
coordinating center.

In the study's first phase, participants will receive
counseling to help them make lifestyle changes to reduce their
weight. These lifestyle changes will include reducing calories
and increasing physical activity. Participants will be
encouraged to follow the DASH eating plan, which has been shown
to reduce blood pressure and cholesterol. DASH is high in fiber
and low in saturated fat, cholesterol and total fat, and
emphasizes fruits, vegetables and lowfat dairy foods. Phase I
participants will keep food and fitness diaries to monitor
their diet and physical activity. Those who lose nine or more
pounds after five months will be eligible to enroll in Phase
II.

In Phase II, participants will be randomly assigned to one
of three weight-maintenance strategies: self-directed/usual
care (SD/UC); personal contact (PC); and interactive technology
(IT). The SD/UC group will meet once with a health counselor
for advice on how to maintain their weight loss and to discuss
their own weight loss plans. They also will receive educational
materials about diet and physical activity.

Those in the PC group will receive personal guidance and
counseling on how to maintain their weight loss through monthly
telephone calls and occasional visits with a health
counselor.

Participants in the IT group will use an Internet-based,
individually tailored, interactive computer program to help
them keep their weight off. They can use the program as often
as they wish and can log on anywhere they have Internet access:
at home, work, a school, or a public library. They also will
receive weekly e-mails with tailored messages on their progress
that include links to the Web site. Further, they will receive
reminders by an interactive voice phone system to log onto the
study's Web site and respond to e-mail.

"The study will compare these two methods with the
self-directed/usual care group," said Svetkey. "The study
involves a large, diverse group of overweight and obese people,
and will determine the impact of these maintenance strategies
on their weight and heart disease risk factors. It also will
see if the strategies have other effects, such as on
participants' quality of life."

"The Surgeon General, the Secretary of Health and Human
Services, the medical community -– everyone recommends that
Americans maintain a healthy weight," said Eva Obarzanek,
Ph.D., NHLBI nutritionist and project officer for the Weight
Loss Maintenance study. "But very few people become 'successful
long-term losers.' This study will test two behavioral methods
to help people keep lost weight off for the rest of their
lives, especially people who are at a high risk of developing
heart disease and other serious conditions."

Those interested in finding out about enrolling in the study
can call the site near them: for Duke University Medical
Center, (919) 419-5904; for Pennington, (225) 763-2596; for
Kaiser Permanente, (503) 499-5766; for Johns Hopkins, (410)
281-1881.

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