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 IBT-alone, 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.

Trial registration: ClinicalTrials.gov NCT02911818.

© 2018 The Obesity Society.

Figures

Figure 1.

CONSORT diagram showing screening, randomization, and assessment of study participants. Weight was measured at week 52 on 137 of 150 (91.3%) participants, and all participants were included in the intention-to-treat analyses.

Figure 2.

Estimated mean percentage reduction in baseline weight over 52 weeks in the intention-to-treat-population (N=150, with 50 participants in each treatment group). P values for pairwise comparisons at weeks 24 and week 52 are available in Table 2.

Figure 3.

Panel A shows the percentage of participants in each group in the ITT population (N=150) who lost 5% or more of baseline weight at week 24 and week 52. (Participants with missing weights were assumed not to have met the categorical loss.) Panels B and C show the percentages of participants who lost ≥10% and ≥15% of baseline weight, respectively. Percentages are cumulative; the percentage of participants, for example, that lost ≥5% of baseline weight includes the percentage that lost 10% or more.

Figure 4.

The figure shows mean weight losses for the three groups in the intention-to-treat population (N=150) at weeks 24 and 52 based on attendance of IBT visits. Forty percent (n=20) of IBT-alone, 60% (n=30) of IBT-liraglutide, and 58% (n=29) of Multi-component participants attended all 21 treatment visits (p=.09 for difference among groups). The remaining 71 participants who did not have “full attendance” completed a mean of 14.0±6.6 visits (66.7±31.2% of possible visits). Among participants without “full attendance,” the 30 IBT-alone participants attended a mean of 11.3±7.3 visits (54.0±34.7%), the 20 IBT-liraglutide participants attended 16.4±4.3 sessions (78.1±20.6%), and the 21 Multi-component participants attended 15.5±6.1 sessions (73.9±28.9%). The IBT-alone group differed significantly from IBT-liraglutide (p=0.017) but not from the Multi-component group (p=0.053).