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

NCT04614545 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-948
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adherence to Weight Management Program

  12 weeks

• Adherence to Medication Use

  12 weeks

• Percentage of Patients That Tolerated Full Dosage of Phentermine (37.5mg)

  12 weeks

• Percentage of Patients Who Achieved More Than 5% Weight Loss Over the Course of the Study (12 Weeks)

  12 weeks

Study Arms (2)

Virtual Visits

EXPERIMENTAL

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; Behavioral: Dietary program; Behavioral: Exercise program

Face to face visits

ACTIVE COMPARATOR

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; Behavioral: Dietary program; Behavioral: Exercise program

Interventions

Phentermine 37.5 Mg DRUG

Patients will receive 37.5 mg of phentermine daily for a 12 week duration

Also known as: Lomaira

Face to face visits; Virtual Visits

Dietary program BEHAVIORAL

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

Face to face visits; Virtual Visits

Exercise program BEHAVIORAL

Patients will be provided with a personalized exercise program

Face to face visits; Virtual Visits

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (11)

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  PMID: 27272580 BACKGROUND

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  PMID: 24222017 BACKGROUND

• 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.

  PMID: 29244650 BACKGROUND

• 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.

  PMID: 21815990 BACKGROUND

• 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.

  PMID: 21779086 BACKGROUND

• 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.

  PMID: 23736363 BACKGROUND

• 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 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. doi: 10.2337/dc10-2415. Epub 2011 May 18.

  PMID: 21593294 RESULT

• 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: 10.1210/jc.2014-3415. Epub 2015 Jan 15.

  PMID: 25590212 RESULT

• 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. Epub 2019 Jun 26.

  PMID: 31241358 RESULT

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  PMID: 32313674 RESULT

• Griebeler ML, Butsch WS, Rodriguez P, Lomeli L, Kampert M, Makin V, Alwahab UA, Borukh E, Daigle E, Bena J, Pantalone KM, Burguera B. The use of virtual visits for obesity pharmacotherapy in patients with overweight or obesity compared with in-person encounters. Obesity (Silver Spring). 2022 Nov;30(11):2194-2203. doi: 10.1002/oby.23548. Epub 2022 Sep 25.

  PMID: 36156456 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Phentermine; Resistance Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Marcio Griebeler
• Organization: The Cleveland Clinic Foundation

jenkink@ccf.org

216.444.6568

Study Officials

• Marcio Griebeler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Endocrinologist

Model Details: 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

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: January 1, 2021
• Primary Completion: August 27, 2021
• Study Completion: September 29, 2022
• Last Updated: December 7, 2022
• Results First Posted: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)