Intensive Behavioral Therapy for Obesity Combined with Liraglutide 3.0 mg: A Randomized Controlled Trial

Abstract

Objective: The Centers for Medicare and Medicaid Services (CMS) covers intensive behavioral therapy (IBT) for obesity. The efficacy, however, of the specific approach has never been evaluated in a randomized trial, as described here. The 1-year trial also assessed whether the addition to IBT of liraglutide 3.0 mg would significantly increase weight loss and whether the provision of meal replacements would add further benefit. Methods: A total of 150 adults with obesity were randomly assigned to: IBT (IBT-alone), providing 21 counseling visits; IBT combined with liraglutide (IBT-liraglutide); or IBT-liraglutide combined for 12 weeks with a 1,000-to 1,200-kcal/d meal-replacement diet (Multicomponent). All participants received weekly IBT visits in month 1, every-other-week visits in months 2 to 6, and monthly sessions thereafter.Results: Ninety-one percent of participants completed 1 year, at which time mean (± SEM) losses for IBTalone, IBT-liraglutide, and Muticomponent participants were 6.1 ± 1.3%, 11.5 ± 1.3%, and 11.8 ± 1.3% of baseline weight, respectively. Fully 44.0%, 70.0%, and 74.0% of these participants lost ≥ 5% of weight, respectively. The liraglutide-treated groups were superior to IBT-alone on both outcomes. Weight loss in all three groups was associated with clinically meaningful improvements in cardiometabolic risk factors. Conclusions: The findings demonstrate the efficacy of IBT for obesity and the potential benefit of adding pharmacotherapy to this approach.

Perceptions of a large amount of food based on binge‐eating disorder diagnosis

“…This supports current practices in CBT for BED and behavioral weight management, which often address establishing regular eating patterns, controlling impulses to eat, and reducing hunger (e.g., (Murphy, Straebler, Cooper, & Fairburn, 2010;Wadden et al, 2019). This supports current practices in CBT for BED and behavioral weight management, which often address establishing regular eating patterns, controlling impulses to eat, and reducing hunger (e.g., (Murphy, Straebler, Cooper, & Fairburn, 2010;Wadden et al, 2019).…”

Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial

“…To our knowledge, SCALE IBT represents only the second randomized controlled evaluation of the CMS‐based IBT benefit alone and combined with liraglutide 3.0 mg. The previously described trial by Wadden et al observed a significantly greater mean 1‐year weight loss of 11.5% in participants who received IBT‐liraglutide ( n = 50) compared with a loss of 6.1% for those treated with IBT alone ( n = 50). At week 24, participants in the two groups lost 10.1% and 5.4% of their baseline body weight, respectively, with 86% and 56% losing ≥ 3 kg and thus being eligible for additional IBT visits according to CMS criteria.…”

A Protocol to Deliver Intensive Behavioral Therapy (IBT) for Obesity in Primary Care Settings: The MODEL‐IBT Program

“…We are encouraged by the weight losses obtained with IBT alone in the Wadden et al study . However, the study clearly needs to be replicated to determine whether the results are generalizable beyond our single site, with its skilled interventionists and selected research participants.…”

“…Weight losses in the Novo Nordisk‐sponsored trial compare favorably with those from the MODEL‐IBT study , the latter being expected to produce greater losses with IBT alone, given our investigative team's experience with this approach. The results achieved by the RDs in the Novo Nordisk trial are encouraging, given that some dietitians had little experience with IBT, and many of their site investigators had minimal exposure to behavioral methods of weight control.…”

“…Wadden et al recently completed a randomized controlled trial that provided 14 CMS‐style IBT visits in the first 24 weeks, followed by an additional 7 monthly visits from weeks 24 to 52 (i.e., a total of 21 visits). (All participants were provided monthly IBT visits from weeks 24 to 52, regardless of whether they lost ≥ 3 kg at week 24, as required by CMS.)…”