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This randomized controlled trial (RCT) tested effectiveness of adaptive SMART stepped-care treatment to "standard" behavioral weight loss (BWL [standard]) for patients with binge-eating disorder (BED) and obesity. One hundred ninety-one patients were randomly assigned to 6 months of BWL (standard; n = 39) or stepped care (n = 152). Within stepped care, patients started with BWL for 1 month; treatment responders continued BWL, whereas nonresponders switched to cognitive-behavioral therapy (CBT), and patients receiving stepped care were additionally randomized to weight-loss medication or placebo (double-blind) for the remaining 5 months. Independent assessments were performed reliably at baseline, throughout treatment, and posttreatment. Intent-to-treat (ITT) analyses of remission rates (zero binges/month) revealed that BWL (standard) and stepped care did not differ (74.4% vs. 66.5%); within stepped care, remission rates ranged 40.0% to 83.3%, with medication significantly superior to placebo (overall) and among nonresponders switched to CBT. Mixed-models analyses of binge-eating frequency revealed significant time effects, but BWL (standard) and stepped care did not differ; within stepped care, medication was significantly superior to placebo and among nonresponders switched to CBT. Mixed models revealed significant weight loss, but BWL (standard; 5.1% weight-loss) and stepped care (5.8% weight-loss) did not differ; within stepped care (range = 0.4% to 8.8% weight-loss), medication was significantly superior to placebo and among both responders continued on BWL and nonresponders switched to CBT. In summary, BWL (standard) and adaptive stepped-care treatments produced robust improvements in binge eating and weight loss in patients with BED/obesity. Within adaptive stepped care, weight-loss medication enhanced outcomes for BED/obesity. Implications for clinical practice and future adaptive designs are offered. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
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Name: The American psychologist
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Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.
Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.
Clinical study in which a prospectively planned opportunity is included to modify trial designs and hypotheses based on analysis of data from subjects in the study.
Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.
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