Comparing a Virtual vs. Face to Face Weight Management Program Using Phentermine for Patients With Overweight or Obesity

Obesity Clinical Trial

Official title:

The Use of a Virtual Weight Management Program for Prescription of Phentermine in Patients With Overweight or Obesity Compared to Standard Face to Face Visits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614545
• Other study ID #: 20-948
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: September 29, 2022

Study information

• Verified date: November 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 29, 2022
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years old

• Body mass index (BMI) greater than or equal to 27 with 1 or more comorbidities (hypertension, diabetes, sleep apnea, fatty liver disease, PCOS, dyslipidemia, congestive heart failure, osteoarthritis) OR a BMI or 30 or greater

• Able to log into an online platform or have a smartphone

• Willing to join a virtual weight management program

Exclusion Criteria:

• Contraindication for use of phentermine

• Female who is pregnant, breast-feeding, or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods

• Participation in another clinical trial within 30 days of screening

• Cardiovascular disease including uncontrolled hypertension or history of arrhythmias

• Treatment with any medication with the intention of weight loss within 180 days before screening

• Use of Topiramate within 180 days of screening

• Previous history of bariatric surgery or use of minimally invasive weight loss devices

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Phentermine 37.5 Mg
Patients will receive 37.5 mg of phentermine daily for a 12 week duration

Behavioral:
• Dietary program
Patients will be able to select either the Mediterranean diet or the Ketogenic diet and will work with a dietician
• Exercise program
Patients will be provided with a personalized exercise program

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (10)

Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, Ryan DH, Still CD; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342-62. doi: 10. — View Citation

Bersoux S, Byun TH, Chaliki SS, Poole KG. Pharmacotherapy for obesity: What you need to know. Cleve Clin J Med. 2017 Dec;84(12):951-958. doi: 10.3949/ccjm.84a.16094. Review. — View Citation

Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458. — View Citation

Hendricks EJ, Srisurapanont M, Schmidt SL, Haggard M, Souter S, Mitchell CL, De Marco DG, Hendricks MJ, Istratiy Y, Greenway FL. Addiction potential of phentermine prescribed during long-term treatment of obesity. Int J Obes (Lond). 2014 Feb;38(2):292-8. doi: 10.1038/ijo.2013.74. Epub 2013 May 17. — View Citation

Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available. Erratum In: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40. — View Citation

Lee M, Lauren BN, Zhan T, Choi J, Klebanoff M, Abu Dayyeh B, Taveras EM, Corey K, Kaplan L, Hur C. The cost-effectiveness of pharmacotherapy and lifestyle intervention in the treatment of obesity. Obes Sci Pract. 2019 Dec 10;6(2):162-170. doi: 10.1002/osp — View Citation

Moroshko I, Brennan L, O'Brien P. Predictors of dropout in weight loss interventions: a systematic review of the literature. Obes Rev. 2011 Nov;12(11):912-34. doi: 10.1111/j.1467-789X.2011.00915.x. Epub 2011 Aug 5. Review. — View Citation

Shibuya K, Ali KF, Ji X, Milinoivh A, Bauman J, Kattan MW, Pantalone KM, Burguera B. THE BENEFIT OF SHORT-TERM WEIGHT LOSS WITH ANTI-OBESITY MEDICATIONS IN REAL-WORLD CLINICAL PRACTICE. Endocr Pract. 2019 Oct;25(10):1022-1028. doi: 10.4158/EP-2019-0081. E — View Citation

Wadden TA, Neiberg RH, Wing RR, Clark JM, Delahanty LM, Hill JO, Krakoff J, Otto A, Ryan DH, Vitolins MZ; Look AHEAD Research Group. Four-year weight losses in the Look AHEAD study: factors associated with long-term success. Obesity (Silver Spring). 2011 Oct;19(10):1987-98. doi: 10.1038/oby.2011.230. Epub 2011 Jul 21. — View Citation

Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, Hill JO, Brancati FL, Peters A, Wagenknecht L; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight (Percentage)	The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight.	12 weeks
Secondary	Adherence to Weight Management Program	Assessed as percentage of patients who completed all visits	12 weeks
Secondary	Adherence to Medication Use	Percentage of patients that took the medication as prescribed	12 weeks
Secondary	Percentage of Patients That Tolerated Full Dosage of Phentermine (37.5mg)		12 weeks
Secondary	Percentage of Patients Who Achieved More Than 5% Weight Loss Over the Course of the Study (12 Weeks)		12 weeks