Trial Outcomes & Findings for Comparing a Virtual vs. Face to Face Weight Management Program Using Phentermine for Patients With Overweight or Obesity (NCT NCT04614545)
NCT ID: NCT04614545
Last Updated: 2022-12-07
Results Overview
The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-12-07
Participant Flow
Participant milestones
| Measure |
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing a Virtual vs. Face to Face Weight Management Program Using Phentermine for Patients With Overweight or Obesity
Baseline characteristics by cohort
| Measure |
Virtual Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Face to Face Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
70 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
31 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
70 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight.
Outcome measures
| Measure |
Virtual Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Face to Face Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
|---|---|---|
|
Change in Body Weight (Percentage)
|
-6.61 mean change in body weight (%)
Interval -7.72 to -5.49
|
-7.68 mean change in body weight (%)
Interval -8.9 to -6.45
|
SECONDARY outcome
Timeframe: 12 weeksAssessed as percentage of patients who completed all visits
Outcome measures
| Measure |
Virtual Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Face to Face Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
|---|---|---|
|
Adherence to Weight Management Program
|
82.9 Percentage of completed patients
|
62.9 Percentage of completed patients
|
SECONDARY outcome
Timeframe: 12 weeksPercentage of patients that took the medication as prescribed
Outcome measures
| Measure |
Virtual Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Face to Face Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
|---|---|---|
|
Adherence to Medication Use
|
93.3 Percentage of pts completed medication
|
83.3 Percentage of pts completed medication
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Virtual Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Face to Face Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
|---|---|---|
|
Percentage of Patients That Tolerated Full Dosage of Phentermine (37.5mg)
|
85.7 Percentage of patients on full dose
|
90 Percentage of patients on full dose
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Virtual Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Face to Face Visits
n=35 Participants
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
|---|---|---|
|
Percentage of Patients Who Achieved More Than 5% Weight Loss Over the Course of the Study (12 Weeks)
|
64.7 Percentage of patients with >5% wt loss
Interval 50.5 to 82.9
|
70.5 Percentage of patients with >5% wt loss
Interval 55.1 to 90.1
|
Adverse Events
Virtual Visits
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Face to Face Visits
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Virtual Visits
n=35 participants at risk
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
Face to Face Visits
n=35 participants at risk
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.
Phentermine 37.5 Mg: Patients will receive 37.5 mg of phentermine daily for a 12 week duration
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
|
|---|---|---|
|
Gastrointestinal disorders
Nausea/Vomiting
|
5.7%
2/35 • Number of events 2 • Through study completion, an average of 12 weeks
|
0.00%
0/35 • Through study completion, an average of 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • Through study completion, an average of 12 weeks
|
2.9%
1/35 • Number of events 1 • Through study completion, an average of 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Right paresthesia
|
2.9%
1/35 • Number of events 1 • Through study completion, an average of 12 weeks
|
0.00%
0/35 • Through study completion, an average of 12 weeks
|
|
Nervous system disorders
Dizziness/fainting
|
2.9%
1/35 • Number of events 1 • Through study completion, an average of 12 weeks
|
0.00%
0/35 • Through study completion, an average of 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
2.9%
1/35 • Number of events 1 • Through study completion, an average of 12 weeks
|
0.00%
0/35 • Through study completion, an average of 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Wrist Strain
|
2.9%
1/35 • Number of events 1 • Through study completion, an average of 12 weeks
|
0.00%
0/35 • Through study completion, an average of 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place