July 15, 2003 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 5-month weight loss program; phase II will try to help those who lose 9 or more pounds in phase I keep the weight off for 2 ½ 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 Dr. Claude Lenfant. "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 Dr. Laura Svetkey, Director of the Duke Hypertension Center and of Clinical Research at the Sarah Stedman Nutrition and Metabolism Center at Duke University in Durham, NC, 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; Pennington Biomedical Research Center at Louisiana State University in Baton Rouge; Kaiser Permanente Center for Health Research (KPCHR) in Portland, OR; 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 9 or more pounds after 5 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 Dr. Eva Obarzanek, 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, 919-419-5904; for Pennington, 225-763-2596; for Kaiser Permanente, 503-499-5766; for Johns Hopkins, 410-281-1881.
NHLBI press releases and other materials, including an "Aim For A Healthy Weight" Web page, are available online at http://www.nhlbi.nih.gov
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