Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial

Abstract

Importance: The clinical efficacy of antiobesity medications (AOMs) as adjuncts to lifestyle intervention is well characterized, but data regarding their use in conjunction with workplace wellness plans are lacking, and coverage of AOMs by US private employers is limited.

Objective: To determine the effect of combining AOMs with a comprehensive, interdisciplinary, employer-based weight management program (WMP) compared with the WMP alone on weight loss, treatment adherence, and work productivity and limitations.

Design, setting, and participants: This 1-year, single-center, open-label, parallel-group, real-world, randomized clinical trial was conducted at the Cleveland Clinic's Endocrinology and Metabolism Institute in Cleveland, Ohio, from January 7, 2019, to May 22, 2020. Participants were adults with obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] ≥30) enrolled in the Cleveland Clinic Employee Health Plan.

Interventions: In total, 200 participants were randomized 1:1, 100 participants to WMP combined with an AOM (WMP+Rx), and 100 participants to WMP alone. The WMP was the Cleveland Clinic Endocrinology and Metabolism Institute's employer-based integrated medical WMP implemented through monthly multidisciplinary shared medical appointments. Participants in the WMP+Rx group initiated treatment with 1 of 5 US Food and Drug Administration-approved medications for chronic weight management (orlistat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, and liraglutide, 3.0 mg) according to standard clinical practice.

Main outcomes and measures: The primary end point was the percentage change in body weight from baseline to month 12.

Results: The 200 participants were predominately (177 of 200 [88.5%]) women, had a mean (SD) age of 50.0 (10.3) years, and a mean (SD) baseline weight of 105.0 (19.0) kg. For the primary intention-to-treat estimand, the estimated mean (SE) weight loss was -7.7% (0.7%) for the WMP+Rx group vs -4.2% (0.7%) for the WMP group, with an estimated treatment difference of -3.5% (95% CI, -5.5% to -1.5%) (P < .001). The estimated percentage of participants achieving at least 5% weight loss was 62.5% for WMP+Rx vs 44.8% for WMP (P = .02). The rate of attendance at shared medical appointments was higher for the WMP+Rx group than for the WMP group. No meaningful differences in patient-reported work productivity or limitation measures were observed.

Conclusions and relevance: Clinically meaningful superior mean weight loss was achieved when access to AOMs was provided in the real-world setting of an employer-based WMP, compared with the WMP alone. Such results may inform employer decisions regarding AOM coverage and guide best practices for comprehensive, interdisciplinary employer-based WMPs.

Trial registration: ClinicalTrials.gov Identifier: NCT03799198.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Pantalone reported receiving personal fees from AstraZeneca, Bayer, Corcept Therapeutics, Diasome, Eli Lilly and Company, Merck & Co, Novo Nordisk, and Sanofi; and receiving research support from Bayer, Merck & Co, and Novo Nordisk. Dr Smolarz, Ms Ramasamy, and Dr Baz Hecht are employees of Novo Nordisk and hold equity in Novo Nordisk. Mr Harty reported being an employee of HealthCore Inc, which was contracted by Novo Nordisk to conduct the study and to perform analyses presented in the current work during the conduct of the study. Dr Rogen reported receiving personal fees and research support from Novo Nordisk. Drs Griebeler and Burguera reported receiving grants from Novo Nordisk during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.. Participant Disposition

BW indicates body weight; EMR, electronic medical record; ITT, intention to treat; SMA, shared medical appointment; WMP, weight management program alone; and WMP+Rx, WMP in combination with medication for chronic weight management.

Figure 2.. Change in Percentage Body Weight From Baseline to 12 Months, Primary End Point

ITT indicates intention to treat; WMP, weight management program; and WMP+Rx, WMP plus antiobesity medication. Mean baseline indicates mean body weight at baseline, and error bars indicate 95% CI. All comparisons are significantly different at P < .001.

Figure 3.. Secondary End Points of Categorical Weight Loss at 12 Months Compared With Baseline

ITT indicates intention to treat; WMP, weight management program; and WMP+Rx, WMP in combination with medication for chronic weight management. A, Participants were dichotomized based on body weight loss at month 12 compared with baseline. The proportion of participants achieving the end point were analyzed using a logistic regression model with treatment as categorical effect and baseline weight as covariate. B, A mixed model for repeated measurements included all participants, but for participants considered nonadherent to randomized treatment, body weight data following nonadherence was censored, and data prior to nonadherence was used to model percentage change in month 12 body weight. aP = .02. bP = .07. cP < .001. dP = .005.

Figure 4.. Treatment Effect on Change in the Secondary End Points of Work Productivity and Work Limitations

ITT indicates intention to treat; WMP, weight management program; and WMP+Rx, WMP in combination with medication for chronic weight management.