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.
Background Weight-loss medications are recommended as an adjunctto a comprehensive program of diet, exercise, and behavior therapybut 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 obeseadults to receive 15 mg of sibutramine per day alone, deliveredby a primary care provider in eight visits of 10 to 15 minuteseach; lifestyle-modification counseling alone, delivered in30 group sessions; sibutramine plus 30 group sessions of lifestyle-modificationcounseling (i.e., combined therapy); or sibutramine plus brieflifestyle-modification counseling delivered by a primary careprovider in eight visits of 10 to 15 minutes each. All subjectswere prescribed a diet of 1200 to 1500 kcal per day and thesame exercise regimen.
Results At one year, subjects who received combined therapylost a mean (±SD) of 12.1±9.8 kg, whereas thosereceiving sibutramine alone lost 5.0±7.4 kg, those treatedby lifestyle modification alone lost 6.7±7.9 kg, andthose receiving sibutramine plus brief therapy lost 7.5±8.0kg (P<0.001). Those in the combined-therapy group who frequentlyrecorded their food intake lost more weight than those who didso infrequently (18.1±9.8 kg vs. 7.7±7.5 kg, P=0.04).
Conclusions The combination of medication and group lifestylemodification resulted in more weight loss than either medicationor lifestyle modification alone. The results underscore theimportance of prescribing weight-loss medications in combinationwith, 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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