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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03799198
• Other study ID #: NN8022-4432
• Secondary ID: U1111-1218-8104
• Status: Completed
• Phase: Phase 4
• Start date: January 7, 2019
• Est. completion date: May 22, 2020

Study information

• Verified date: November 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 22, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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]).

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Percentage change in body weight from baseline (month 0) to month 12 is presented.	Month 0, month 12
Secondary	Participants Achieving 5% or More Reduction in Body Weight	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.	Month 12
Secondary	Participants Achieving 10% or More Reduction in Body Weight	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.	Month 12
Secondary	Number of Shared Medical Appointments (SMAs) Attended	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.	Months 0-12
Secondary	Participants Attending 9 or More SMAs	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.	Months 0-12
Secondary	Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management	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.	Months 0-12
Secondary	Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days	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.	Months 0-12
Secondary	Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)	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.	Month 0, month 12
Secondary	Change in 'Time Management' as Measured by WLQ-8	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.	Month 0, month 12
Secondary	Change in 'Physical Tasks' as Measured by WLQ-8	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.	Month 0, month 12
Secondary	Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8	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.	Month 0, month 12
Secondary	Change in 'Output Tasks' as Measured by WLQ-8	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.	Month 0, month 12
Secondary	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)	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.	Month 0, month 12
Secondary	Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP	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.	Month 0, month 12
Secondary	Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP	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.	Month 0, month 12
Secondary	Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP	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.	Month 0, month 12