Comparing a Virtual vs. Face to Face Weight Management Program Using Phentermine for Patients With Overweight or Obesity
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will study the effects associated with the prescription of phentermine in a
      virtual setting, comparing with prescription of phentermine via a standard face-to-face visit
      for patients with obesity or overweight.
    

Detailed description: 
      Obesity is a major healthcare problem in the United States affecting over one-third of the
      population, often increasing the risk of other comorbidities like hypertension, dyslipidemia,
      type 2 diabetes mellitus (1) and is also associated with increased risk of all-cause
      mortality and cardiovascular death. Modest weight loss of 5% has been associated with
      improvement in obesity as well as obesity related comorbidities and quality of life. (2) The
      cornerstone for treatment of obesity is behavioral modification and lifestyle changes
      including dietary modification and physical activity. (3) Adaptive physiologic responses due
      to increased appetite makes it difficult to achieve weight loss with lifestyle intervention
      alone. Anti-obesity medications (AOM) are often required as adjuvant therapy for weight loss
      induction and maintenance, and have the potential to augment further weight loss. (4)

      Obesity is a chronic disease that often requires chronic treatment and the use of
      FDA-approved medications to reduce the appetite set-point in the hypothalamus. Currently, the
      United States Food and Drug Administration (FDA)-approved medications include: phentermine,
      phentermine-topiramate (Qsymia), bupropion-naltrexone (Contrave), orlistat (Xenical, Alli)
      and liraglutide (Saxenda). AOMs remain underutilized and just a minority of patients receive
      prescription treatment due to cost of therapy, lack of insurance coverage, old requirements
      of frequent face-to-face visits, lack of physician training, among others. Phentermine is the
      most affordable and the most commonly prescribed pharmacotherapy for weight loss; however,
      FDA approval is only for the short-term use (90 days), and in the State of Ohio, face-to-face
      visits every 30 days were required until recently during the course of treatment. (5) A
      recent study found that in real-world practice AOMs are associated with clinically meaningful
      additional weight loss and phentermine therapy was associated with the most weight loss (3.7%
      weight loss in 12 weeks and an average of 7-12% when enhanced to our current weight
      management program. (6). Another study has demonstrated that phentermine is one of the most
      cost-effective pharmacologic weight-loss strategies. (7)

      A barrier to successful weight loss is patient attrition, as often more than half of patients
      do not complete lifestyle-based weight loss intervention. (8) Scalable methods for the
      delivery of obesity treatment that encourages patient participation are needed. A potential
      way to improve patient participation and weight loss outcomes is through the use of virtual
      medical visits, remote monitoring, and e-Health. Telemedicine is a growing segment of medical
      field with the potential to improve access to care removing geographic barriers, extending
      care to home with the introduction with new technology capabilities that patients are already
      using on their personal lives. These new modalities have the potential to decrease costs,
      provide scalable and more accessibility and provide the same quality of care. Several studies
      have shown the utility of e-Health in the management of chronic conditions, concluding the
      behavioral changes can be achieved using technological innovation. (9, 10)

      More recently, the emergency COVID-19 pandemic presented an unprecedented challenge to the
      current healthcare system, and all institutions are rapidly changing their health care
      delivery model and quickly adopting telemedicine and remote monitoring and very soon this
      type of care may become standard. Frequent visits have been shown to be effective
      facilitating changes in lifestyle, while also addressing psychological aspects. During the
      last few months, the Endocrinology and Metabolism Institute (EMI) at Cleveland Clinic has
      switched obesity care to essentially 90% virtual visits. In addition, the federal government
      and the State of Ohio recently relaxed standards for prescribing controlled substances so
      providers are now able to prescribe phentermine (and other anti-obesity medications) via
      telemedicine. If the study is able to demonstrate that a meaningful and safe weight loss can
      also be achieved via virtual care, this could support making current relaxed recommendations
      of the State of Ohio permanent, which would represent a significant shift in the current laws
      and would greatly benefit the care of patients suffering with obesity.

      Cleveland Clinic's weight management clinic provides an ideal environment to investigate the
      impact of virtual weight management program for the prescribing of phentermine. The proposed
      trial will afford the opportunity to study the effects of a well-established weight
      management program associated with the prescription of phentermine in a virtual setting,
      comparing its effects with standard face-to-face visit. At the present time, there are no
      studies which have demonstrated that the use of phentermine, prescribed via telemedicine,
      will lead to the same outcomes in terms of weight loss. This gap in the literature needs to
      be rapidly answered in order to shift the current standard of weight management care from
      face-to-face to virtually provided care. This trial has the potential to lead to major impact
      on how we manage patients with obesity. If the study shows that a virtual weight management
      program may be as effective as face-to-face encounters for prescription of anti-obesity
      mediation (initially with phentermine due to feasibility) this will pave the way for future
      clinical trials leveraging virtual care as standard of care for management of obesity and
      prescription of anti-obesity medications.
    

Intervention name(s): Phentermine 37.5 Mg; Dietary program; Exercise program
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Patients will receive 37.5 mg of phentermine daily for a 12 week duration; Patients will be able to select either the Mediterranean diet or the Ketogenic diet and will work with a dietician; Patients will be provided with a personalized exercise program
Other intervention name(s): Lomaira
Intervention MeSH terms: Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Single-center, Parallel-group trial comparing the use of virtual visit for prescription of phentermine versus standard face-to-face visits for weight management
Masking: None (Open Label)
Primary purpose: Treatment