This appendix has been provided by the authors to give readers additional information about their work.

Supplement to: Wadden TA et al. Randomized Trial of Lifestyle Modification and Pharmacotherapy for Obesity. N Engl J Med 2005;353(20):2111-20.

Supplementary Appendix: Treatment Implementation

Applicants to the study were informed in writing that, on the basis of previous findings, all four treatments were expected to produce an average weight loss of 5 to 15 percent of initial weight and that no placebo groups were included in the trial. They were further informed that the investigators did not know which of the treatments would have the most favorable long-term effects on weight and health and that "the study is designed to answer these questions." This approach was intended to provide positive treatment expectations for all four interventions. Study personnel encouraged all subjects, regardless of group assignment, to follow their treatment plan as closely as possible to obtain maximum benefit.

The four primary care providers followed written protocols in conducting treatment visits for both the group given sibutramine alone and that provided sibutramine plus brief therapy. Each provider treated an equal number of subjects in each of these two groups. Providers met regularly with the project physician to review treatment implementation and clinical concerns.

The three psychologists followed written protocols in providing all group lifestyle modification. Each led the same number of treatment groups for lifestyle–modification alone as for combined therapy. Psychologists met regularly to review the treatment protocols and clinical concerns.


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