| Primary | Change in Body Weight | Percentage change in body weight from baseline (month 0) to month 12 is presented. | The FAS comprised of all randomized participants. | Posted | | Least Squares Mean | Standard Error | Percent change of body weight | | Month 0, month 12 | | | | ID | Title | Description |
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| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-7.69± 0.72
- OG001-4.19± 0.73
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | ANCOVA | | <0.001 | | Treatment Difference | -3.50 | Standard Error of the Mean | 1.02 | 2-Sided | 95 | -5.51 | -1.50 | | | | | Superiority | | |
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| 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. | The FAS comprised of all randomized participants. | Posted | | Number | | Percentage of participants | | Month 12 | | | | ID | Title | Description |
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| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. | Posted | | Number | | Percentage of participants | | Month 12 | | | | ID | Title | Description |
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| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. | Posted | | Mean | Standard Deviation | SMAs | | Months 0-12 | | | | ID | Title | Description |
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| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. | Posted | | Count of Participants | | Participants | | Months 0-12 | | | | ID | Title | Description |
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| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. | Posted | | Mean | Standard Deviation | Proportion of days | | Months 0-12 | | | | ID | Title | Description |
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| OG000 | 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®. |
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| 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. | The FAS comprised of all randomized participants. | Posted | | Count of Participants | | Participants | | Months 0-12 | | | | ID | Title | Description |
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| OG000 | 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®. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. Overall number of participants analyzed=number of participants contributed to the analysis. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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| 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. | The FAS comprised of all randomized participants. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Month 0, month 12 | | | | ID | Title | Description |
|---|
| OG000 | 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®. | | OG001 | Weight Management Program (WMP) | Participants were to receive Cleveland Clinic's existing Integrated Medical WMP. |
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