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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT03799198 (opens ClinicalTrials.gov in a new tab)Other idNN8022-4432Other idU1111-1218-8104
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Liraglutide, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 4
Enrollment
200 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
7 Jan 2019
Primary completion
22 May 2020
Completion
22 May 2020
First posted
10 Jan 2019
Last update posted
14 Nov 2022
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 4

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

    NCT03799198

    7 Jan 2019 to 22 May 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Weight Management Program (WMP)Other
  • Medication for chronic weight management (Rx)Drug

Arms2

  • 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.

  • Active comparator

    WMP alone

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Body Weight

    Time frame · Month 0, month 12

    Registry description

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

Secondary outcomes(15)

  1. Participants Achieving 5% or More Reduction in Body Weight

    Time frame · Month 12

    Registry 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.

  2. Participants Achieving 10% or More Reduction in Body Weight

    Time frame · Month 12

    Registry 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.

  3. Number of Shared Medical Appointments (SMAs) Attended

    Time frame · Months 0-12

    Registry 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.

  4. Participants Attending 9 or More SMAs

    Time frame · Months 0-12

    Registry 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.

  5. Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management

    Time frame · Months 0-12

    Registry 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.

  6. Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days

    Time frame · Months 0-12

    Registry 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.

  7. Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)

    Time frame · Month 0, month 12

    Registry 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.

  8. Change in 'Time Management' as Measured by WLQ-8

    Time frame · Month 0, month 12

    Registry 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.

  9. Change in 'Physical Tasks' as Measured by WLQ-8

    Time frame · Month 0, month 12

    Registry 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.

  10. Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8

    Time frame · Month 0, month 12

    Registry 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.

  11. Change in 'Output Tasks' as Measured by WLQ-8

    Time frame · Month 0, month 12

    Registry 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.

  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)

    Time frame · Month 0, month 12

    Registry 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.

  13. Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP

    Time frame · Month 0, month 12

    Registry 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.

  14. Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP

    Time frame · Month 0, month 12

    Registry 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.

  15. Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP

    Time frame · Month 0, month 12

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Month 0, month 12

Change in Body Weight

GroupValue (Percent change of body weight)Spread
Weight Management Program (WMP) + Rx-7.690.72
Weight Management Program (WMP)-4.190.73
Secondary and other outcome results(7)
Secondary outcomeNumber· Month 12

Participants Achieving 5% or More Reduction in Body Weight

GroupValue (Percentage of participants)
Weight Management Program (WMP) + Rx62.5
Weight Management Program (WMP)44.8
Secondary outcomeNumber· Month 12

Participants Achieving 10% or More Reduction in Body Weight

GroupValue (Percentage of participants)
Weight Management Program (WMP) + Rx34.7
Weight Management Program (WMP)22.4
Secondary outcomeMean· Months 0-12

Number of Shared Medical Appointments (SMAs) Attended

GroupValue (SMAs)Spread
Weight Management Program (WMP) + Rx9.72.98
Weight Management Program (WMP)7.43.90
Secondary outcomeCount of participants· Months 0-12

Participants Attending 9 or More SMAs

GroupValue (Participants)
Weight Management Program (WMP) + Rx79
Weight Management Program (WMP)51
Secondary outcomeMean· Months 0-12

Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management

GroupValue (Proportion of days)Spread
Weight Management Program (WMP) + Rx66.4827.096
Secondary outcomeCount of participants· Months 0-12

Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days

GroupValue (Participants)
Weight Management Program (WMP) + Rx43
Secondary outcomeLeast squares mean· Month 0, month 12

Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)

GroupValue (Score on a scale)Spread
Weight Management Program (WMP) + Rx-0.060.06
Weight Management Program (WMP)-0.030.06

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Weight Management Program (WMP) + RxParticipants 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®.0 / 1008 / 1000 / 0
Weight Management Program (WMP)Participants were to receive Cleveland Clinic's existing Integrated Medical WMP.1 / 10011 / 1000 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

4 results

Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial.

Pantalone et al. 2021JAMA network opencited by 24

PMID 34255049PMC8278271DOI 10.1001/jamanetworkopen.2021.16595PUB-34255049

Free to read · publisher termsCC BY-NC-ND4 results
Read at sourceSee results (4)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPantalone KM, Rogen B, Zirm P, Xiao H, Bena J, Barnard G, Borukh E, Peechakara S, Griebeler ML, Young JB, Burguera B. An Obesity-Centric Approach with and Without Anti-Obesity Medications Compared to the Usual-Care Approach to Management of Patients with Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial (EMPOWER-T2D). Diabetes Ther. 2024 May;15(5):1201-1214. doi: 10.1007/s13300-024-01563-0. Epub 2024 Apr 4. PMID 38573466

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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