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Original Article
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Volume 353:2111-2120 November 17, 2005 Number 20
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Randomized Trial of Lifestyle Modification and Pharmacotherapy for Obesity
Thomas A. Wadden, Ph.D., Robert I. Berkowitz, M.D., Leslie G. Womble, Ph.D., David B. Sarwer, Ph.D., Suzanne Phelan, Ph.D., Robert K. Cato, M.D., Louise A. Hesson, M.S.N., Suzette Y. Osei, M.D., Ph.D., Rosalind Kaplan, M.D., and Albert J. Stunkard, M.D.

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ABSTRACT

Background Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This practice is likely to limit therapeutic benefits.

Methods In this one-year trial, we randomly assigned 224 obese adults to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in eight visits of 10 to 15 minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestyle-modification counseling (i.e., combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen.

Results At one year, subjects who received combined therapy lost a mean (±SD) of 12.1±9.8 kg, whereas those receiving sibutramine alone lost 5.0±7.4 kg, those treated by lifestyle modification alone lost 6.7±7.9 kg, and those receiving sibutramine plus brief therapy lost 7.5±8.0 kg (P<0.001). Those in the combined-therapy group who frequently recorded their food intake lost more weight than those who did so infrequently (18.1±9.8 kg vs. 7.7±7.5 kg, P=0.04).

Conclusions The combination of medication and group lifestyle modification resulted in more weight loss than either medication or lifestyle modification alone. The results underscore the importance of prescribing weight-loss medications in combination with, rather than in lieu of, lifestyle modification.


Source Information

From the University of Pennsylvania School of Medicine, Philadelphia (T.A.W., R.I.B., L.G.W., D.B.S., R.K.C., L.A.H., S.Y.O., A.J.S.); the Children's Hospital of Philadelphia, Philadelphia (R.I.B.); Brown Medical School, Providence, R.I. (S.P.); and GlaxoSmithKline, Philadelphia (S.Y.O.) and Bryn Mawr, Pa. (R.K.).

Address reprint requests to Dr. Wadden at the Department of Psychiatry, University of Pennsylvania School of Medicine, 3535 Market St., Suite 3029, Philadelphia, PA 19104, or at wadden{at}mail.med.upenn.edu.

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