Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity
Status: | Enrolling by invitation |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/28/2019 |
Start Date: | January 7, 2019 |
End Date: | August 23, 2020 |
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
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.
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.
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
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