Severe Obesity Treatments Focus of $5 Million Study

BUFFALO, N.Y. -- BlueCross BlueShield of Western New York and the University at Buffalo School of Public Health and Health Professions today announced a five-year research and treatment program for the severely obese that will study the effects of weight-loss alternatives to gastric bypass surgery.

The $5 million program is a landmark effort to stem the public-health obesity crisis. According to the Centers for Disease Control and Prevention, the annual cost of obesity in the United States is $117 billion, including health-care expenses and lost productivity. An estimated $4.5 billion was spent on gastric bypass surgery in 2005 alone, a 1,000 percent increase over 1995.

The treatment and research program, to be conducted by UB researchers, will be the first of its kind to use and assess proven scientific methods for treating the severely obese, defined as being those who are approximately 100 pounds or more over ideal weight. Participants will be monitored in one of four different programs. Each will use various combinations of behavior modification and lifestyle changes, meal replacement, counseling and medication.

The program, announced today at a press conference at the university, was hailed by UB President John B. Simpson, Ph.D., as a hallmark collaboration between two institutions deeply concerned about the community's health and welfare.

"The mission of UB's School of Public Health and Health Professions is driven by the vision of a stronger, healthier community -- a vision shared by our partners at BlueCross BlueShield," Simpson said. "We are very grateful for this major program, which will go a long way toward helping us to realize this vision together."

"The U.S. Surgeon General calls obesity 'the terror within' and has issued a call to action," stated Alphonso O'Neil-White, president & CEO of BlueCross BlueShield of Western New York. "BlueCross BlueShield's investment with the University at Buffalo will generate scientific evidence to develop a gold standard, best practices to treat the severely obese. This research initiative is necessary and is urgent, because the costs to our society and our economy -- $117 billion a year and growing -- are far too great," he added.

Simpson added: "Promoting health and wellness, and developing pioneering new methods of preventing and treating serious diseases such as extreme obesity, are the essential strategies by which we are working to serve the health-care needs of our larger communities," Simpson added. "We are proud to partner with BlueCross BlueShield to address this serious public-health issue, one with critical significance not only to our region, but also to our state, nation and world."

The study, to be conducted in the Center for Preventive Medicine in the UB School of Public Health and Health Professions, will involve 280 BlueCross BlueShield subscribers who will be divided into four groups, each of which will follow a different non-surgical regimen for treating obesity.

At the end of the study, the outcomes and costs of medical care of the groups will be compared, as well as compared with those of a population of patients who have undergone bariatric gastric-bypass surgery.

Maurizio Trevisan, M.D., dean of the UB School of Public Health and Health Professions and a co-investigator on the study, called it "a great example of what can be achieved through collaboration among institutions in Western New York.

"This project fulfills two important aspects of our school mission: We will address an important health issue our community is facing, and at the same time contribute to the advancement of the scientific knowledge in an area critical to public health."

Michael F. Noe, M.D., UB clinical professor of social and preventive medicine and associate dean for community relations and clinical affairs, is principal investigator on the study.

"More than 4.7 percent of the adult population in the U.S. is seriously obese and at risk for the major complications of that condition," Noe noted.

"While many meet the criteria for bariatric surgery and a growing number of procedures are being performed annually, surgical management is not without its complications and, for various reasons, is not an attractive option for many people or not available to them.

"It's essential that alternative, nonsurgical approaches to help people who are severely overweight be evaluated," said Noe, "and we need to determine if these new approaches are safe, doable and cost-effective. We think this study will provide some definitive answers."

Noe's co-investigators, in addition to Trevisan, are Leonard Epstein, Ph.D., UB professor of pediatrics and a leading authority on obesity; John Leddy, M.D., UB associate professor of clinical orthopaedics, and Jeffrey Lackner, Psy.D., UB assistant professor of medicine and a specialist in behavioral medicine. Cheryl Kennedy is project director.

The overarching aim of the study is to determine the effects of different types of treatment regimens on weight loss in the extremely obese. As part of the study, the researchers will measure in all subjects conditions associated with weight loss, such as changes in blood pressure, blood glucose, blood lipids and health-related quality of life. Obesity-related sleep disorders and genetic factors that may influence weight gain also will be assessed.

Recruitment of participants for the study from among persons covered by BlueCross BlueShield is underway. Participants will be assigned randomly to one of four groups representing different nonsurgical approaches to managing severe obesity. There will be 70 subjects in each group.

The first group will follow a low-calorie diet of between 1,200 and 1,500 calories a day and participate in behavioral treatment. The second will follow a very-low-calorie diet of 800 calories daily and participate in behavioral treatment. The low-calorie diet, behavioral treatment and use of medication will be the regimen of participants in the third group. The approach with the fourth group will involve the very-low-calorie diet, behavioral treatment and medication.

The behavioral treatment for all four groups will focus on lifestyle changes through education and skill-building in the areas of dietary change, relapse prevention and motivational strategies. The medication used will be one of two weight-loss drugs approved for long-term use, depending on each participant's co-existing health conditions.

The investigators theorize that those who stay on the very-low-calorie diet and receive medication and behavior treatment will achieve the best results.