Employees of Cleveland Clinic covered by the EHP (employee health plan) are being offered a unique opportunity to participate in a pragmatic clinical trial on weight loss. Cleveland Clinic’s Endocrinology & Metabolism Institute (EMI) has partnered with Novo Nordisk to study the effectiveness of the health system’s employee health plan-sponsored integrated weight management program – both with and without the use of FDA-approved anti-obesity (weight loss) medications.
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The program is an extension of the institute’s successful Integrated Weight Management Program, led by Bartolome Burguera, MD, PhD, Chair of the Endocrinology & Metabolism Institute. Study participants must have a BMI of ≥ 30. After a one-on-one face-to-face medical visit with a weight management specialist, eligible patients will be randomized to one of two groups. Each group will receive care in the context of shared medical appointments, with six to eight other participants, once per month for 12 months. One group of patients will also receive an anti-obesity (weight loss) medication, for a nominal monthly fee, simulating the co-payment patients would pay at a retail pharmacy if the medication was covered by their employer. All study participants will choose one of three dietary programs (Mediterranean, protein-sparing modified fast [PSMF] or meal replacement), and meet with a nutritionist to review the chosen diet, also in the setting of a shared nutrition appointment. Exercise prescriptions are also prescribed by an exercise physiologist.
The Cleveland Clinic EMI team managing the program are (from left to right): Elena Borukh, MD; Mario Scarcipino; Bartolome Burguera, MD, PhD; Ron Gambino; Amy Orasko; Kevin Pantalone, DO; and Ula Abed Alwahab, MD.
The study will look at the effectiveness of the five FDA-approved anti-obesity medications (AOMs). The goal is to find out if anti-obesity medication increases successful long-term weight loss in the context of SMAs. The specific AOM prescribed to a patient will be determined by patient and provider after a thorough review of their medical history and the risks and benefits of each AOM.
“This is a pragmatic clinical trial because it will be a real-world experience for participants,” says Co-Principal Investigator and Endocrinologist Kevin Pantalone, DO, ECNU, FACE, Director of Clinical Research for the EMI. “It’s exciting because this pragmatic/real-world weight loss trial will be available to our employees and their spouses, to help them attain their weight loss goals for 2019, and the integrated weight management program is covered by our EHP insurance.”
The program focuses on five key weight-loss areas: diet and nutrition, exercise, appetite control, sleep disorders, and psychological issues with stress, depression and anxiety. Additional specialty referrals may occur, at the discretion of the study physicians, for sleep studies, stress testing, and stress management with psychology professionals. “Because if you don’t address all of the health issues around weight, there will not be a great chance for long-term success,” Dr. Pantalone explains.
In addition to the BMI requirement, participants must have no history of diabetes, no prior history of bariatric surgery, and no recent treatment with any medication with the intention of weight loss. Dr. Pantalone sees a twofold benefit of the study: it will help to assess the effectiveness of AOMs in addition to a robust employer-sponsored weight management program, and it will afford some employees the opportunity to engage in chronic weight management.
Getting this clinical trial up and running took nearly two years, Dr. Pantalone notes, as the EMI team worked to garner support from the EHP, the study sponsor, institutional leaders, and to meet all requirements of the institutional review board (IRB). Recruitment is underway for employees to join the program, with the goal of having all participants through the program by mid-2020 and study results available by year-end 2020.
Watch this video with Dr. Pantalone to learn more about the program.