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Trial record 54 of 69 for:    ORLISTAT

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

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ClinicalTrials.gov Identifier: NCT03799198
Recruitment Status : Active, not recruiting
First Posted : January 10, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 7, 2019
Estimated Primary Completion Date : August 23, 2020
Estimated Study Completion Date : August 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Week 0, Week 56 ]
    Measured in percentage.


Secondary Outcome Measures :
  1. Participants achieving 5% or more reduction in body weight [ Time Frame: Week 56 ]
    Percentage of participants (yes/no).

  2. Participants achieving 10% or more reduction in body weight [ Time Frame: Week 56 ]
    Percentage of participants (yes/no).

  3. Number of SMAs attended [ Time Frame: Week 56 ]
    Number of SMAs.

  4. Participants attending 9 or more SMAs [ Time Frame: Week 56 ]
    Percentage of participants (yes/no).

  5. Proportion of days covered by prescription claims for medication for chronic weight management [ Time Frame: Week 56 ]
    Percentage of days. 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: Week 56 ]
    Percentage of participants (yes/no). 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: Week 0, Week 56 ]
    Measured in points, with higher points indicating greater limitations, i.e. worse

  8. Change in 'time management' as measured by WLQ-8 [ Time Frame: Week 0, Week 56 ]
    Measured in points, with higher points indicating greater limitations, i.e. worse outcomes.

  9. Change in 'physical tasks' as measured by WLQ-8 [ Time Frame: Week 0, Week 56 ]
    Measured in points, with higher points indicating greater limitations, i.e. worse outcomes.

  10. Change in 'mental/interpersonal tasks' as measured by WLQ-8 [ Time Frame: Week 0, Week 56 ]
    Measured in points, with higher points indicating greater limitations, i.e. worse outcomes.

  11. Change in "Output Tasks " as measured by WLQ-8 [ Time Frame: Week 0, Week 56 ]
    Measured in points, with higher points indicating greater limitations, i.e. worse outcomes.

  12. Change in '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: Week 0, Week 56 ]
    Measured in percentages, with higher scores indicating greater impairment and less productivity, i.e. worse outcomes.

  13. Change in 'impairment while working due to excess weight' as measured by WPAI:SHP [ Time Frame: Week 0, Week 56 ]
    Measured in percentages, with higher scores indicating greater impairment and less productivity, i.e. worse outcomes.

  14. Change in 'overall work impairment due to excess weight' as measured by WPAI:SHP [ Time Frame: Week 0, Week 56 ]
    Measured in percentages, with higher scores indicating greater impairment and less productivity, i.e. worse outcomes.

  15. Change in 'activity impairment due to excess weight' as measured by WPAI:SHP [ Time Frame: Week 0, Week 56 ]
    Measured in percentages, with higher scores indicating greater impairment and less productivity, i.e. worse outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799198


Locations
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United States, Ohio
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03799198     History of Changes
Other Study ID Numbers: NN8022-4432
U1111-1218-8104 ( Other Identifier: World Health Organization (WHO) )
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://www.novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liraglutide
Topiramate
Phentermine
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anticonvulsants
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action