Orlistat with behavioral weight loss for obesity with versus without binge eating disorder: Randomized placebo-controlled trial at a community mental health center serving educationally and economically disadvantaged Latino/as

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Abstract

Objective

This study was a randomized placebo-controlled trial testing the addition of orlistat to behavioral weight loss for obesity in Spanish-speaking-only Latino/as with versus without binge eating disorder (BED) performed at a community mental health center serving educationally- and economically-disadvantaged patients. Latino/as have high rates of obesity but are under-represented in obesity treatment studies and despite comparable-to-or-higher rates of BED than Whites, Latino/as are under-represented in BED treatment studies. BED is associated with obesity but whether it predicts/moderates treatment outcomes remains uncertain. Thus, this study also tested whether BED prospectively predicts/moderates outcomes.

Methods

Seventy-nine obese Spanish-speaking-only Latino/as with BED (N = 40) versus without BED (N = 39) at a community mental health center were randomly assigned to four-months of orlistat-plus-BWL or placebo-plus-BWL. BWL was culturally-enhanced modification of Diabetes-Prevention-Program delivered in weekly sessions in Spanish. Orlistat (120 mg tid) and matching-placebo delivered with standard clinical-management. Participants were assessed independently throughout treatment, post-treatment, and six-month follow-up.

Results

78% completed treatments; completion rates did not differ significantly by medication or BED. Intent-to-treat mixed-models analyses revealed significant improvements in binge eating, eating-psychopathology, and depression, and significant – albeit modest – weight-loss. Overall, the addition of orlistat to BWL was not associated with greater improvements; however, BED moderated weight-loss: orlistat-plus-BWL produced significantly greater weight-loss in non-BED group but not in BED. Improvements were maintained through 6-month follow-up; BED significantly predicted/moderated increases in eating concerns and depression following treatment. Within BED-group, binge-eating remission rates were 65% (post-treatment) and 50% (follow-up).

Conclusions

In this controlled trial performed at community mental health center serving educationally- and economically-disadvantaged Spanish-speaking-only Latino/as with co-morbid psychiatric needs, we observed outcomes for the BWL plus orlistat/placebo medication that approximate or are slightly dampened relative to the literature for efficacy trials with much more restrictive obese and BED samples. In this complex patient group, adding orlistat to BWL produced greater weight-loss than adding placebo among obese patients without BED but not among those with BED. Although 50% of BED patients maintained abstinence from binge-eating following these specific obesity treatments (BWL plus orlistat/placebo), BED was a negative prognostic indicator for some outcome variables.

Trial Registration: clinicaltrials.gov Identifier: NCT00516919.

Highlights

► RCT testing behavioral weight loss and orlistat for obesity with and without binge eating. ► Educationally- and economically-disadvantaged Spanish-speaking-only Latino/as with mental health needs. ► Adding orlistat to behavioral weight loss produced modest weight loss amongst non-binge-eaters. ► Comparable outcomes for behavioral weight loss for binge eating as documented in the efficacy literature.

Section snippets

Participants

Participants were a consecutive series of 79 monolingual (Spanish-speaking-only) obese Latino/as (65 females, 14 males) recruited from clinical teams and referrals at a community mental health center serving economically disadvantaged persons with mental health needs. This study enrolled participants from August 2007 through October 2009. This RCT was designed with the goal of obtaining a broadly clinically-relevant obese patient group (aged 21–65 years of age with body mass index (BMI) of 30

Randomization and progression through the study

Fig. 1 summarizes the progression of participants through the study treatments and assessments. Of the 79 randomized patients, 40 (n = 20 with BED, n = 20 without-BED) received orlistat-plus-BWL and 39 (n = 20 with BED, n = 19 without BED) received placebo-plus-BWL. Treatment completion rates by medication status did not differ significantly: 75% (n = 30 of 40) for orlistat-plus-BWL and 82% (n = 32 of 39) for placebo-plus-BWL (χ2(1) = .58, p = .45). Treatment completion rates by BED status did

Discussion

This study was a randomized double-blind placebo-controlled treatment study performed with Spanish-speaking-only obese Latino/as with versus without BED at a community mental health center serving educationally- and economically-disadvantaged patients with mental health needs. This study tested the acute effects of adding orlistat to BWL, tested the durability of outcomes through 6-month follow-up after completing treatments, and represents the first controlled prospective study of

Biomedical support disclosures

The authors report no commercial or biomedical industry support or conflicts of interest. This research was supported by a grant from the Donaghue Foundation (Dr. Grilo). Preparation of this paper was also supported, in part, by the National Institutes of Health grant K24 DK070052 (Dr. Grilo) No additional funding was received for the completion of this work.

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