Clinical trial NCT03799198: Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Body Weight
timeFrame: Month 0, month 12
Secondary outcomes:
measure: Participants Achieving 5% or More Reduction in Body Weight
timeFrame: Month 12
measure: Participants Achieving 10% or More Reduction in Body Weight
timeFrame: Month 12
measure: Number of Shared Medical Appointments (SMAs) Attended
timeFrame: Months 0-12
measure: Participants Attending 9 or More SMAs
timeFrame: Months 0-12
measure: Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management
timeFrame: Months 0-12
measure: Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days
timeFrame: Months 0-12
measure: Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)
timeFrame: Month 0, month 12
measure: Change in 'Time Management' as Measured by WLQ-8
timeFrame: Month 0, month 12
measure: Change in 'Physical Tasks' as Measured by WLQ-8
timeFrame: Month 0, month 12
measure: Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8
timeFrame: Month 0, month 12
measure: Change in 'Output Tasks' as Measured by WLQ-8
timeFrame: Month 0, month 12
measure: 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)
timeFrame: Month 0, month 12
measure: Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP
timeFrame: Month 0, month 12
measure: Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP
timeFrame: Month 0, month 12
measure: Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP
timeFrame: Month 0, month 12
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Pantalone KM, Smolarz BG, Ramasamy A, Baz Hecht M, Harty BJ, Rogen B, Griebeler ML, Borukh E, Young JB, Burguera B. Effectiveness of Combining Antiobesity Medication With an Employer-Based Weight Management Program for Treatment of Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116595. doi: 10.1001/jamanetworkopen.2021.16595.