Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: Weight Management Program (WMP); Medication for chronic weight management (Rx)
Intervention description: 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.; 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]).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

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