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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03799198
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Weight Management Program (WMP); Drug: Medication for chronic weight management (Rx)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 7, 2019
• Actual Primary Completion Date: May 22, 2020
• Actual Study Completion Date: May 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.; Drug: 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]).
Active Comparator: WMP alone Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Body Weight [Month 0, month 12]

   Percentage change in body weight from baseline (month 0) to month 12 is presented.

Secondary Outcome Measures

1. Participants Achieving 5% or More Reduction in Body Weight [Month 12]

   The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented.

2. Participants Achieving 10% or More Reduction in Body Weight [Month 12]

   The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented.

3. Number of Shared Medical Appointments (SMAs) Attended [Months 0-12]

   Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented.

4. Participants Attending 9 or More SMAs [Months 0-12]

   Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented.

5. Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management [Months 0-12]

   Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx.

6. Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days [Months 0-12]

   Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx.

7. Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) [Month 0, month 12]

   The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented.

8. Change in 'Time Management' as Measured by WLQ-8 [Month 0, month 12]

   The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented.

9. Change in 'Physical Tasks' as Measured by WLQ-8 [Month 0, month 12]

   The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented.

10. Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 [Month 0, month 12]

    The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented.

11. Change in 'Output Tasks' as Measured by WLQ-8 [Month 0, month 12]

    The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented.

12. Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP) [Month 0, month 12]

    The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.

13. Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP [Month 0, month 12]

    The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.

14. Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP [Month 0, month 12]

    The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.

15. Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP [Month 0, month 12]

    The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

• Study Protocol - Oct 10, 2018
• Statistical Analysis Plan - May 18, 2020

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03799198
• Other Study ID Numbers: NN8022-4432; U1111-1218-8104
• First Posted: Jan 10, 2019
• Last Update Posted: Dec 2, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	The trial was conducted at a single site in the United States.
Pre-assignment Detail	Participants were randomized in a 1:1 manner to receive either Cleveland Clinic's Integrated Medical Weight Management Program (WMP) with medication for chronic weight management (WMP + Rx) or Cleveland Clinic's Integrated Medical WMP alone (WMP).

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Period Title: Overall Study
STARTED	100	100
Full Analysis Set (FAS)	100	100
COMPLETED	96	91
NOT COMPLETED	4	9

Baseline Characteristics

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)	Total
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.	Total of all reporting groups
Overall Participants	100	100	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.0 (10.43)	49.1 (10.11)	50.0 (10.29)
Sex: Female, Male (Count of Participants)
Female	88 88%	89 89%	177 88.5%
Male	12 12%	11 11%	23 11.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 4%	0 0%	4 2%
Not Hispanic or Latino	96 96%	100 100%	196 98%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	80 80%	66 66%	146 73%
Black or African American	19 19%	33 33%	52 26%
Asian/White	1 1%	0 0%	1 0.5%
India	0 0%	1 1%	1 0.5%

Outcome Measures

1. Primary Outcome

Title	Change in Body Weight
Description	Percentage change in body weight from baseline (month 0) to month 12 is presented.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	100	100
Least Squares Mean (Standard Error) [Percent change of body weight]	-7.69 (0.72)	-4.19 (0.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Weight Management Program (WMP) + Rx, Weight Management Program (WMP)
	Comments	Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Treatment Difference
	Estimated Value	-3.50
	Confidence Interval	(2-Sided) 95%; -5.51 to -1.50
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.02
	Estimation Comments

2. Secondary Outcome

Title	Participants Achieving 5% or More Reduction in Body Weight
Description	The percentage of participants achieving 5% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 5% or more reduction in body weight from baseline at month 12 is presented.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	100	100
Number [Percentage of participants]	62.5 62.5%	44.8 44.8%

3. Secondary Outcome

Title	Participants Achieving 10% or More Reduction in Body Weight
Description	The percentage of participants achieving 10% or more reduction in body weight was analyzed using a logistic regression model with treatment as categorical effect and baseline weight (kg) as covariate. Percentage of participants who achieved 10% or more reduction in body weight from baseline at month 12 is presented.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	100	100
Number [Percentage of participants]	34.7 34.7%	22.4 22.4%

4. Secondary Outcome

Title	Number of Shared Medical Appointments (SMAs) Attended
Description	Shared medical appointments (SMAs) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. The mean number of SMAs attended by the participants are presented.
Time Frame	Months 0-12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	100	100
Mean (Standard Deviation) [SMAs]	9.7 (2.98)	7.4 (3.90)

5. Secondary Outcome

Title	Participants Attending 9 or More SMAs
Description	Shared medical appointment (SMA) is a concept that combines group appointments for participants with clinical intervention, consisting of encounters with a nutritionist, exercise physiologist, and endocrinologist/obesity medicine specialist. Number of participants who attended 9 or more SMAs is presented.
Time Frame	Months 0-12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	100	100
Count of Participants [Participants]	79 79%	51 51%

6. Secondary Outcome

Title	Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management
Description	Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Proportion of days covered by prescription claims for medication for chronic weight management is presented. This endpoint is applicable only for treatment arm, WMP + Rx.
Time Frame	Months 0-12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.
Measure Participants	100
Mean (Standard Deviation) [Proportion of days]	66.48 (27.096)

7. Secondary Outcome

Title	Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days
Description	Participants who enrolled in the WMP + Rx arm were provided a prescription for medication indicated for chronic weight management. Number of participants covered by prescription claims for medication for chronic weight management for at least 80% of days is presented. This endpoint is applicable only for treatment arm, WMP + Rx.
Time Frame	Months 0-12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.
Measure Participants	100
Count of Participants [Participants]	43 43%

8. Secondary Outcome

Title	Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)
Description	The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. The WLQ-8 produces subscale scores as well as an index of overall at-work productivity loss. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'At-Work Productivity Loss Index' from month 0 to month 12 is presented.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	100	98
Least Squares Mean (Standard Error) [Score on a scale]	-0.06 (0.06)	-0.03 (0.06)

9. Secondary Outcome

Title	Change in 'Time Management' as Measured by WLQ-8
Description	The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'time management' from month 0 to month 12 is presented.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	98	95
Least Squares Mean (Standard Error) [Score on a scale]	-0.10 (0.07)	-0.19 (0.07)

10. Secondary Outcome

Title	Change in 'Physical Tasks' as Measured by WLQ-8
Description	The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'physical tasks' from month 0 to month 12 is presented.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	99	98
Least Squares Mean (Standard Error) [Score on a scale]	-0.09 (0.11)	-0.05 (0.11)

11. Secondary Outcome

Title	Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8
Description	The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'mental/interpersonal tasks' from month 0 to month 12 is presented.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	98	97
Least Squares Mean (Standard Error) [Score on a scale]	-0.06 (0.09)	-0.03 (0.09)

12. Secondary Outcome

Title	Change in 'Output Tasks' as Measured by WLQ-8
Description	The WLQ-8 questionnaire assesses the degree to which participants have difficulty related to time management, physical tasks, mental/interpersonal tasks, and output tasks due to their physical and/or emotional health. WLQ-8 outcomes are expressed as proportion time with difficulty, with higher scores indicating greater limitations, i.e., worse outcomes. The score ranges from 1 to 5 where '1' represents none of the time and, '5' represents all of the time. Change in 'output tasks' from month 0 to month 12 is presented.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	97	98
Least Squares Mean (Standard Error) [Score on a scale]	0.07 (0.10)	0.12 (0.11)

13. Secondary Outcome

Title	Change in 'Absenteeism: Percent Work Time Missed Due to Excess Weight' as Measured by Work Productivity and Activity Impairment Questionnaire Specific Health Problem V2.0 (WPAI:SHP)
Description	The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	95	95
Least Squares Mean (Standard Error) [Score on a scale]	-0.43 (0.17)	-0.48 (0.19)

14. Secondary Outcome

Title	Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP
Description	The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	95	95
Least Squares Mean (Standard Error) [Score on a scale]	-1.88 (1.62)	-1.94 (1.82)

15. Secondary Outcome

Title	Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP
Description	The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	95	95
Least Squares Mean (Standard Error) [Score on a scale]	-1.84 (1.62)	-1.89 (1.82)

16. Secondary Outcome

Title	Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP
Description	The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Time Frame	Month 0, month 12

Outcome Measure Data

Analysis Population Description

The FAS comprised of all randomized participants.

Arm/Group Title	Weight Management Program (WMP) + Rx	Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
Measure Participants	100	100
Least Squares Mean (Standard Error) [Score on a scale]	-9.95 (2.53)	-7.20 (2.69)

Adverse Events

Time Frame	Months 0 - 12
Adverse Event Reporting Description	All study medications used in this study were approved for the treatment of chronic weight management at the time of their use and prescribed at the discretion of the study clinician according to routine practice. For this reason, only SAEs and pregnancies (in female participants) were collected.
Arm/Group Title	Weight Management Program (WMP) + Rx		Weight Management Program (WMP)
Arm/Group Description	Participants were to receive Cleveland Clinic's existing Integrated Medical WMP combined with medication for chronic weight management. Participants were prescribed any one of the 5 approved medicines: Xenical®, Belviq®, Qsymia®, Contrave® and Saxenda®.		Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.
All Cause Mortality
	Weight Management Program (WMP) + Rx		Weight Management Program (WMP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		1/100 (1%)
Serious Adverse Events
	Weight Management Program (WMP) + Rx		Weight Management Program (WMP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/100 (8%)		11/100 (11%)
Blood and lymphatic system disorders
Plasma Cell Myeloma	0/100 (0%)	0	1/100 (1%)	1
Cardiac disorders
Atrial Fibrillation	0/100 (0%)	0	1/100 (1%)	1
Atrial Tachycardia	0/100 (0%)	0	1/100 (1%)	1
Congestive Cardiomyopathy	0/100 (0%)	0	1/100 (1%)	1
Gastrointestinal disorders
Appendicitis	0/100 (0%)	0	1/100 (1%)	1
Gastroenteritis Salmonella	0/100 (0%)	0	1/100 (1%)	1
Procedural Vomiting	0/100 (0%)	0	1/100 (1%)	1
General disorders
Non-Cardiac Chest Pain	1/100 (1%)	1	0/100 (0%)	0
Hepatobiliary disorders
Cholelithiasis	1/100 (1%)	1	0/100 (0%)	0
Infections and infestations
Pyelonephritis	0/100 (0%)	0	1/100 (1%)	1
Metabolism and nutrition disorders
Dehydration	0/100 (0%)	0	1/100 (1%)	1
Malnutrition	0/100 (0%)	0	1/100 (1%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/100 (1%)	1	0/100 (0%)	0
Intervertebral Disc Protrusion	0/100 (0%)	0	1/100 (1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign	0/100 (0%)	0	1/100 (1%)	1
Nervous system disorders
Syncope	1/100 (1%)	1	0/100 (0%)	0
Psychiatric disorders
Depression Suicidal	0/100 (0%)	0	1/100 (1%)	1
Reproductive system and breast disorders
Ovarian Mass	0/100 (0%)	0	1/100 (1%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	1/100 (1%)	1	0/100 (0%)	0
Skin and subcutaneous tissue disorders
Skin Lesion	1/100 (1%)	1	0/100 (0%)	0
Social circumstances
Organ Donor	1/100 (1%)	1	0/100 (0%)	0
Surgical and medical procedures
Gastric Bypass	0/100 (0%)	0	1/100 (1%)	1
Vascular disorders
Dizziness	1/100 (1%)	1	0/100 (0%)	0
Other (Not Including Serious) Adverse Events
	Weight Management Program (WMP) + Rx		Weight Management Program (WMP)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.