Obesity
Conditions
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.
Interventions
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.
DRUGMedication 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 \[under the skin\]).
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Month 0, month 12 | Percentage change in body weight from baseline (month 0) to month 12 is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
The trial was conducted at a single site in the United States.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Weight Management Program (WMP) + Rx 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®. | 100 |
| Weight Management Program (WMP) Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 4 | 8 |
Baseline characteristics
| Characteristic | Weight Management Program (WMP) + Rx | Weight Management Program (WMP) | Total |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 10.43 | 49.1 years STANDARD_DEVIATION 10.11 | 50.0 years STANDARD_DEVIATION 10.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants | 100 Participants | 196 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/White | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 33 Participants | 52 Participants |
| Race/Ethnicity, Customized India | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 80 Participants | 66 Participants | 146 Participants |
| Sex: Female, Male Female | 88 Participants | 89 Participants | 177 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 1 / 100 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 8 / 100 | 11 / 100 |
Outcome results
Primary
Change in Body Weight
Percentage change in body weight from baseline (month 0) to month 12 is presented.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in Body Weight | -7.69 Percent change of body weight | Standard Error 0.72 |
| Weight Management Program (WMP) | Change in Body Weight | -4.19 Percent change of body weight | Standard Error 0.73 |
Comparison: 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.p-value: <0.00195% CI: [-5.51, -1.5]ANCOVA
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | 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) | -0.43 Score on a scale | Standard Error 0.17 |
| Weight Management Program (WMP) | 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) | -0.48 Score on a scale | Standard Error 0.19 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) | -0.06 Score on a scale | Standard Error 0.06 |
| Weight Management Program (WMP) | Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8) | -0.03 Score on a scale | Standard Error 0.06 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 | -0.06 Score on a scale | Standard Error 0.09 |
| Weight Management Program (WMP) | Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8 | -0.03 Score on a scale | Standard Error 0.09 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'Output Tasks' as Measured by WLQ-8 | 0.07 Score on a scale | Standard Error 0.1 |
| Weight Management Program (WMP) | Change in 'Output Tasks' as Measured by WLQ-8 | 0.12 Score on a scale | Standard Error 0.11 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP | -9.95 Score on a scale | Standard Error 2.53 |
| Weight Management Program (WMP) | Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP | -7.20 Score on a scale | Standard Error 2.69 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'Physical Tasks' as Measured by WLQ-8 | -0.09 Score on a scale | Standard Error 0.11 |
| Weight Management Program (WMP) | Change in 'Physical Tasks' as Measured by WLQ-8 | -0.05 Score on a scale | Standard Error 0.11 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP | -1.88 Score on a scale | Standard Error 1.62 |
| Weight Management Program (WMP) | Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP | -1.94 Score on a scale | Standard Error 1.82 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'Time Management' as Measured by WLQ-8 | -0.10 Score on a scale | Standard Error 0.07 |
| Weight Management Program (WMP) | Change in 'Time Management' as Measured by WLQ-8 | -0.19 Score on a scale | Standard Error 0.07 |
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.
Time frame: Month 0, month 12
Population: The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP | -1.84 Score on a scale | Standard Error 1.62 |
| Weight Management Program (WMP) | Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP | -1.89 Score on a scale | Standard Error 1.82 |
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.
Time frame: Months 0-12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Number of Shared Medical Appointments (SMAs) Attended | 9.7 SMAs | Standard Deviation 2.98 |
| Weight Management Program (WMP) | Number of Shared Medical Appointments (SMAs) Attended | 7.4 SMAs | Standard Deviation 3.9 |
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.
Time frame: Month 12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Management Program (WMP) + Rx | Participants Achieving 10% or More Reduction in Body Weight | 34.7 Percentage of participants |
| Weight Management Program (WMP) | Participants Achieving 10% or More Reduction in Body Weight | 22.4 Percentage of participants |
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.
Time frame: Month 12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Weight Management Program (WMP) + Rx | Participants Achieving 5% or More Reduction in Body Weight | 62.5 Percentage of participants |
| Weight Management Program (WMP) | Participants Achieving 5% or More Reduction in Body Weight | 44.8 Percentage of participants |
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.
Time frame: Months 0-12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Weight Management Program (WMP) + Rx | Participants Attending 9 or More SMAs | 79 Participants |
| Weight Management Program (WMP) | Participants Attending 9 or More SMAs | 51 Participants |
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.
Time frame: Months 0-12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Weight Management Program (WMP) + Rx | Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days | 43 Participants |
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.
Time frame: Months 0-12
Population: The FAS comprised of all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Management Program (WMP) + Rx | Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management | 66.48 Proportion of days | Standard Deviation 27.096 |