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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Weight Management Program (WMP) (Other)
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.
干预措施: Medication for chronic weight management (Rx) (Drug)
WMP alone
Participants will receive Cleveland Clinic's Integrated Medical WMP alone for approximately one year.
干预措施: Weight Management Program (WMP) (Other)
结局指标
主要结局
Change in Body Weight
时间窗: Month 0, month 12
Percentage change in body weight from baseline (month 0) to month 12 is presented.
次要结局
- Change in 'Physical Tasks' as Measured by WLQ-8(Month 0, month 12)
- Change in 'Output Tasks' as Measured by WLQ-8(Month 0, month 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)(Month 0, month 12)
- Change in 'Percent Activity Impairment Due to Excess Weight' as Measured by WPAI:SHP(Month 0, month 12)
- Participants Achieving 5% or More Reduction in Body Weight(Month 12)
- Change in 'Work Productivity Loss: Percent Overall Work Impairment Due to Excess Weight' as Measured by WPAI:SHP(Month 0, month 12)
- Participants Achieving 10% or More Reduction in Body Weight(Month 12)
- Participants Covered by Prescription Claims for Medication for Chronic Weight Management for at Least 80% of Days(Months 0-12)
- Change in 'At-Work Productivity Loss Index' as Measured by Work Limitations Questionnaire Self-administered Short-Form (WLQ-8)(Month 0, month 12)
- Participants Attending 9 or More SMAs(Months 0-12)
- Change in 'Time Management' as Measured by WLQ-8(Month 0, month 12)
- Number of Shared Medical Appointments (SMAs) Attended(Months 0-12)
- Proportion of Days Covered by Prescription Claims for Medication for Chronic Weight Management(Months 0-12)
- Change in 'Mental/Interpersonal Tasks' as Measured by WLQ-8(Month 0, month 12)
- Change in 'Presenteeism: Percent Impairment While Working Due to Excess Weight' as Measured by WPAI:SHP(Month 0, month 12)