Lifestyle Treatments in Randomized Clinical Trials of Pharmacotherapies for Obesity

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Abstract
Objective:This meta‐analysis evaluated the types of lifestyle treatments used in published obesity drug studies and assessed their contribution to weight losses associated with pharmacological interventions.Research Methods and Procedures:Randomized, placebo‐controlled, double‐blind clinical trials of anti‐obesity agents that are/were Food and Drug Administration‐approved for the treatment of obesity (both prescription and over‐the‐counter), and drugs that are Food and Drug Administration‐approved and are used off‐label for obesity were included. Studies were located by computer searches of databases (e.g., Medline, PsychInfo) and reviewing tables of content/reference sections of journals, abstracts, previous reviews, past empirical studies, relevant book chapters, and recent issues of journals that regularly publish obesity research. In addition, a number of individuals who regularly publish in the obesity literature were asked to provide personal lists of obesity‐drug studies. Based on the above criteria, a total of 108 randomized clinical trials were located.Results:Balanced‐deficit diets, low‐calorie diets, and self‐monitoring were the most used lifestyle treatments in published obesity studies. They were incorporated into 40.7%, 25%, and 23.1% of pharmacotherapy studies, respectively. Physical activity and other behavioral or psychotherapeutic interventions rarely were used. A substantial portion of weight loss experienced by patients was attributable to both “placebo effects” and to the lifestyle treatments.Discussion:Obesity‐pharmacotherapy trials do not use lifestyle treatments with the frequency expected based on the official positions of most professional organizations concerned with the comprehensive management of obesity.