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Randomized trial of lifestyle modification and pharmacotherapy for obesity.

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.

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  • Authors+Show Affiliations

    ,

    University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. wadden@mail.med.upenn.edu

    , , , , , , , ,

    Source

    The New England journal of medicine 353:20 2005 Nov 17 pg 2111-20

    MeSH

    Adult
    Appetite Depressants
    Cardiovascular Diseases
    Combined Modality Therapy
    Counseling
    Cyclobutanes
    Exercise
    Female
    Humans
    Life Style
    Male
    Middle Aged
    Obesity
    Psychotherapy, Group
    Risk Factors
    Serotonin Uptake Inhibitors
    Weight Loss

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural

    Language

    eng

    PubMed ID

    16291981

    Citation

    Wadden, Thomas A., et al. "Randomized Trial of Lifestyle Modification and Pharmacotherapy for Obesity." The New England Journal of Medicine, vol. 353, no. 20, 2005, pp. 2111-20.
    Wadden TA, Berkowitz RI, Womble LG, et al. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med. 2005;353(20):2111-20.
    Wadden, T. A., Berkowitz, R. I., Womble, L. G., Sarwer, D. B., Phelan, S., Cato, R. K., ... Stunkard, A. J. (2005). Randomized trial of lifestyle modification and pharmacotherapy for obesity. The New England Journal of Medicine, 353(20), pp. 2111-20.
    Wadden TA, et al. Randomized Trial of Lifestyle Modification and Pharmacotherapy for Obesity. N Engl J Med. 2005 Nov 17;353(20):2111-20. PubMed PMID: 16291981.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Randomized trial of lifestyle modification and pharmacotherapy for obesity. AU - Wadden,Thomas A, AU - Berkowitz,Robert I, AU - Womble,Leslie G, AU - Sarwer,David B, AU - Phelan,Suzanne, AU - Cato,Robert K, AU - Hesson,Louise A, AU - Osei,Suzette Y, AU - Kaplan,Rosalind, AU - Stunkard,Albert J, PY - 2005/11/18/pubmed PY - 2005/12/13/medline PY - 2005/11/18/entrez SP - 2111 EP - 20 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 353 IS - 20 N2 - 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. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16291981/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa050156?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -