Can Anti-Obesity Medications Be Effective in Virtual Weight Management Programs?

A new study, which began enrolling in November, is exploring the effectiveness of incorporating anti-obesity medication (AOMs) in a virtual weight management program. The research will compare the effects of AOM prescription in a virtual setting with standard face-to-face visits. Showing that a virtual weight management program may be as effective as face-to-face encounters for prescription of AOMs could shift the current standard practice of obesity management to a more virtual approach.

Although obesity affects one-third of Americans and is associated with increased all-cause mortality and cardiovascular death, more than half of patients do not complete lifestyle-based weight loss intervention. With the impact of COVID-19, telemedicine has become increasingly popular in all aspects of healthcare. At the beginning of the pandemic, Cleveland Clinic’s Endocrinology and Metabolism Institute has transitioned obesity care to essentially 90% virtual visits. At the same time, the federal government and the State of Ohio relaxed their standards for prescribing controlled substances, such as AOMs. Providers are now able to provide phentermine, among other medications, which prior research demonstrated as one of the most cost-effective AOMs, via telemedicine.

Although prior research has shown AOMs be effective with helping lose weight, they remain underutilized. There are two main reasons for this according to Marcio L. Griebeler, MD, an endocrinologist at Cleveland Clinic, and one of the study’s main authors.

“Not all providers are comfortable in prescribing these medications because they have to monitor their patients and they are not sure how the patient will react to any side effects,” explains Dr. Griebeler. “The other reason is that, unfortunately, some of the other anti-obesity medications are expensive because they’re not covered by insurance. The mindset for treating obesity also must change. Not a lot of people are treating obesity as a disease, and until practice shifts to where we treat obesity as a disease, we are going to underutilize AOMs. If we treat obesity we are also treating other comorbidities like diabetes, hypertension, dyslipidemia.”

Objectives

There are three primary objectives for this study. The first is to demonstrate that the use of a virtual weight management program for prescription of phentermine in patients with BMI ≥ 27 with comorbidities or BMI ≥ 30 is non-inferior to the standard face-to-face approach to weight loss during a 90-day course of treatment. The second is to demonstrate that the use of a virtual weight management program for the prescription of phentermine for these patients is as efficacious as the standard face-to-face approach. Finally, it aims to demonstrate that the use of a virtual weight management program for prescription of phentermine leads to more adherence to the weight management program and to the medication when compared to face-to-face visits.

Design and protocol

The prospective, randomized, single-center study will enroll patients who are referred to the Weight Management Clinic at the Department of Endocrinology at the Cleveland Clinic and Internal Medicine Clinic. Patients between the ages of 18 and 67 with documented BMI ≥ 27 with comorbidities or BMI ≥ 30 at the time of the encounter will be screened for inclusion/exclusion criteria to determine their eligibility.

This study will randomize participants into two arms—one arm will consist of virtual visits, and the other will consist of face-to-face care. All subjects, independent of which arm they are assigned will have a face-to-face visit with an obesity specialist for the initial visit. Subjects in the telemedicine arm will also meet with a registered dietitian and exercise physiologist in that first week. Subjects will then be given a daily prescription for 37.5 mg of phentermine and will choose to follow either the Mediterranean diet or Keto diet. Three more virtual visits are scheduled every four weeks to meet with the obesity specialist. Subjects in the face-to-face arm will follow this same schedule except all of their visits will be face-to-face. The primary endpoint is the mean change in body weight from baseline to 12 weeks. All variables will be assessed at baseline, 4, 8 and 12 weeks.

Dr. Griebeler says, “independently of face to face or virtual visits we will closely monitor weight, blood pressure and other vitals during the clinical trial. Patients randomized to the virtual care will receive remote blood pressure monitor and scale. This is one of the first studies looking at AOMs prescribed via telemedicine. We want to prove that it works just as well for virtual patients as it does for face-to-face patients. If we are able to prove there is not a difference between these two types of visits, then hopefully the Ohio laws will recognize this and allow us to prescribe the controlled substances for obesity via telemedicine. In addition to that, we will also able to provide more care virtually and reach more patients that are in need of this type of care. We can shift current practice standards to this model.