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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04614545
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Marcio Griebeler, The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Phentermine 37.5 Mg Behavioral: Dietary program Behavioral: Exercise program Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Virtual Visits

All patients will be seen face to face on visit 1. Patient will be evaluated by an obesity-medicine specialist and also by a registered dietitian and exercise physiologist via telemedicine. Subjects will be prescribed phentermine (37.5 mg po daily; dose may be reduced if not tolerated), and will choose one of two dietary programs (Mediterranean or Keto diet). Weight and vital signs will be monitored remotely and patients will receive a remote scale and a remote blood pressure cuff.

Subjects will then initiate 3 one to one virtual visits with the obesity specialist. On each of this visit the five pillars of weight management will be discussed including nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. A personalized nutrition and exercise program will be developed. If felt relevant by the provider, subjects may also be referred to a mental health specialist and/or sleep clinic. All medical care will be provided virtually.

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

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

Behavioral: Exercise program
Patients will be provided with a personalized exercise program

Active Comparator: Face to face visits

All patients independently of the randomization arm will be seen face to face on visit 1. Patients will be evaluated by an obesity-medicine specialist and patient will also be seen face to face by a registered dietitian and exercise physiologist. Subjects will be prescribed phentermine (37.5 mg po daily; dose may be reduced if not tolerated). Patients will choose one of two dietary programs (Mediterranean or Keto diet). Weight and vital signs will be monitored in each of the visits.

Subjects will then initiate 3 face to face visits with the obesity specialist provider every 4 weeks. The five pillars of weight management will be discussed including nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress.

The patient will be provided a personalized nutrition and exercise program and may be referred to a mental health specialist and/or sleep clinic per provider discretion. All medical care will be provided via a face-to-face manner.

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

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

Behavioral: Exercise program
Patients will be provided with a personalized exercise program




Primary Outcome Measures :
  1. Change in body weight (percentage) [ Time Frame: 12 weeks ]
    The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight.


Secondary Outcome Measures :
  1. Adherence to weight management program [ Time Frame: 12 weeks ]
    Assessed as number of missed visits

  2. Adherence to medication use [ Time Frame: 12 weeks ]
    Assessment of medication compliance

  3. Change in BMI [ Time Frame: 12 weeks ]
    Mean change in BMI from baseline to week 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614545


Contacts
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Contact: Laura Lomeli (216) 445-8354 lomelil@ccf.org
Contact: Jaime Fensterl 216-296-3169 fenstej@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Laura Lomeli       lomelil@ccf.org   
Principal Investigator: Marcio Griebeler, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Marcio Griebeler, MD The Cleveland Clinic
Publications of Results:
Other Publications:
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. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40.

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Responsible Party: Marcio Griebeler, Staff Endocrinologist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04614545    
Other Study ID Numbers: 20-948
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Phentermine
Central Nervous System Stimulants
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action