Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2020-05-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WMP + Rx

Participants will receive Cleveland Clinic's Integrated Medical WMP with medication for chronic weight management (Rx) for approximately one year. After discussing with the study doctor, participants will receive one of the following listed 5 drugs approved by the Food and Drug Administration (FDA) for long-term weight loss: 1) orlistat, 2) lorcaserin or lorcaserin extended-release, 3) phentermine/topiramate extended-release, 4) naltrexone/bupropion extended-release and 5) liraglutide 3.0 mg.

Group Type EXPERIMENTAL

Weight Management Program (WMP)

Intervention Type OTHER

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.

Medication for chronic weight management (Rx)

Intervention Type DRUG

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 \[under the skin\]).

WMP alone

Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year.

Group Type ACTIVE_COMPARATOR

Weight Management Program (WMP)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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 \[under the skin\]).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No