Clinical trial
Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity - a Pragmatic Randomized Trial
Name
NN8022-4432
Description
Researchers are doing this study to compare the effects of drugs approved for long-term weight loss combined with an employer-based weight management program with the effects of the weight management program without drugs for weight loss. If participants agree to be in this study, they will join the Cleveland Clinic Integrated Medical Weight Management Program (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss. Participants have an equal chance of being in either of the treatment groups. The total study duration for the individual participants will be approximately one year.
Trial arms
Trial start
2019-01-07
Estimated PCD
2020-05-22
Trial end
2020-05-22
Status
Completed
Phase
Early phase I
Treatment
Weight Management Program (WMP)
As part of usual care, participants will: 1) Discuss and choose one of three diet options: protein-sparing modified fast, Mediterranean, or meal replacement. 2) Be referred to a nutritionist appointment. 3) Initiate a series of twelve monthly study visits in the context of shared medical appointments (SMAs) covering nutrition, physical activity, appetite control, sleep issues, and anxiety/depression/stress. 4) Be referred to an exercise physiologist for a personalized physical activity program. 5) If assessed relevant by the study clinician, be referred to a mental health specialist and/or sleep clinic.
Arms:
WMP + Rx, WMP alone
Medication for chronic weight management (Rx)
Following listed 5 drugs will be administered as prescribed by the study doctor:
1) Orlistat (Xenical® pills, per os \[p.o.; by mouth\]). 2) Lorcaserin or lorcaserin extended-release (Belviq®/Belviq XR® pills, p.o.). 3) Phentermine/topiramate extended-release (Qsymia® pills, p.o.). 4) Naltrexone/bupropion extended-release (Contrave® pills, p.o.). 5) Liraglutide 3.0 mg (Saxenda® injections, subcutaneously \[under the skin\]).
Arms:
WMP + Rx
Size
200
Primary endpoint
Change in Body Weight
Month 0, month 12
Eligibility criteria
Inclusion Criteria:
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study
* Male or female, age more than or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) more than or equal 30 kg/m\^2
* Enrolled in Cleveland Clinic Employee Health Plan, and expecting to be covered by the Cleveland Clinic Employee Health Plan for the duration of the study
Exclusion Criteria:
* Contraindications to all of the medications approved by the FDA for chronic weight management according to the label
* Previous participation in this study. Participation is defined as signed informed consent
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
* Participation in another clinical trial within 30 days before screening
* Treatment with any medication with the intention of weight loss within 90 days before screening
* Previous or current participation in Cleveland Clinic's Integrated Medical Weight Management Program
* History of (or plans during the study period for) bariatric surgery, or use of minimally-invasive weight loss devices (i.e. Intragastric balloons, lap bands) not removed within 1 year prior to screening
* History of type 1 or type 2 diabetes mellitus
* Hemoglobin A1c (HbA1c) more than or equal to 6.5% at screening or within 90 days prior to randomization
* Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2022-11-14
1 organization
1 product
1 indication
Organization
Novo NordiskIndication
Obesity