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Phase 4 Completed N=70 Randomized Treatment

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

Obesity
Source: ClinicalTrials.gov NCT04614545 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Change in Body Weight (Percentage) — -6.61; -7.68 mean change in body weight (%)
◆ Published Evidence
Highly cited
1,808citations · ~121 / year
Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes.
Diabetes care · 2011 · Open access · High-confidence link

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.

Linked Publications (5)

  • Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes.
    Diabetes care · 2011 · 1,808 citations · Open access · High-confidence link
  • Pharmacological management of obesity: an endocrine Society clinical practice guideline.
    The Journal of clinical endocrinology and metabolism · 2015 · 1,298 citations · Open access · High-confidence link
  • The cost-effectiveness of pharmacotherapy and lifestyle intervention in the treatment of obesity.
    Obesity science & practice · 2020 · 59 citations · Open access · High-confidence link
  • THE BENEFIT OF SHORT-TERM WEIGHT LOSS WITH ANTI-OBESITY MEDICATIONS IN REAL-WORLD CLINICAL PRACTICE.
    Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2019 · 26 citations · High-confidence link
  • The use of virtual visits for obesity pharmacotherapy in patients with overweight or obesity compared with in-person encounters.
    Obesity (Silver Spring, Md.) · 2022 · 19 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Body Weight (Percentage)
-6.61; -7.68
SECONDARY
Adherence to Weight Management Program
82.9; 62.9
SECONDARY
Adherence to Medication Use
93.3; 83.3
SECONDARY
Percentage of Patients That Tolerated Full Dosage of Phentermine (37.5mg)
85.7; 90
SECONDARY
Percentage of Patients Who Achieved More Than 5% Weight Loss Over the Course of the Study (12 Weeks)
64.7; 70.5

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04614545) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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