UPHS Weight Loss Study
2015年5月4日 更新者：University of Pennsylvania
UPHS Weight Loss Study: Evaluating Methods to Use Health Benefits Design to Encourage Employee Weight Loss
The goal of this study is to compare a novel approach using financial incentives to changes in health benefit design and their impact on employee weight loss.
研究概览
详细说明
Employers are increasingly looking for opportunities to encourage weight loss among employees. While studies have shown that financial incentives can effectively encourage weight loss, little is known about their use in health benefits design. The goal of this study is to determine whether a financial incentive program delivered to obese University of Pennsylvania Health System employees can effectively encourage weight loss when compared to changes in health benefit design.
This is a randomized controlled trial involving financial incentives with four study arms: control, delayed gratification, immediate gratification, and financial incentive with frequent feedback. Participation in this study will last about 12 months.
The primary goal of the study is to test the effects of a novel financial incentive program using a lottery with frequent feedback to normal benefit design structures.
研究类型
介入性
注册 (实际的)
201
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults age 18-70
- BMI of 30 or above
Exclusion Criteria:
- Inability to consent
- Illiteracy and/or inability to speak, read, and write English
- Participation in another research study
Conditions that would make participation unsafe:
- Current treatment for drug or alcohol use
- Consumption of at least 5 alcoholic drinks per day
- Myocardial infarction or stroke within the past 6 months
- Current addiction to prescription medicines or street drugs
- Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)
- Pregnant or currently breastfeeding
- Diabetic and using any medicine besides metformin to control blood glucose
- Metastatic cancer
- Unstable medical conditions that would likely prevent the subject from completing the study
- Previous diagnosis of an eating disorder
- History of unsafe weight loss behaviors such as binging or the use of laxatives
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control Arm
No other financial incentive other than for enrollment, 6-month weigh in, and completion.
|
|
|
实验性的：Delayed gratification
In addition to the standard enrollment, 6-month, and completion incentives, if the subject loses 5% of their initial weight by the end of the study, they will receive an annual discount (distributed across bi-weekly pay periods) for 12 months beginning after the 12-month study ends.
Their premium will return to normal price after this 12-month discount ends.
|
|
|
实验性的：Immediate gratification
In addition to the standard enrollment, 6-month, and completion incentives, the subject will be told that they can weigh in again any time before the study ends when they think they have lost 5% of their initial body weight.
If they did meet their 5% goal, they will begin receiving a bi-weekly premium discount during the next pay period for a total duration of 12 months.
Subjects that do not meet the 5% cut off during a weigh in are allowed to re-weigh themselves as many times as they like although they are encouraged to do so when they think they have met their target weight.
Their premium goes back to normal price after this 12-month discount ends.
|
|
|
实验性的：Financial incentive with frequent feedback
In addition to the standard enrollment, 6-month, and completion incentives, the subject will be asked to weigh in on the IncentaHEALTH scales everyday they are at work.
These subjects will participate in a daily lottery with the possibility of winning the same amount as the discount in Arms 2 and 3 over the course of the study.
The subject can choose to select or be designated a two digit number that ranges from 00 to 99.
Each day a lottery will be held and the subject will be given a 1% chance of matching both digits or an 18% chance of matching one digit.
In order to get the lottery winnings, the subject must meet a weight goal that consistently decreases to accumulate to a 5% weight loss by the 6 month mark.
After 6 months, the subject will receive the lottery winnings if they maintain that target weight (initial weight minus 5%) until the end of the 12-month study.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Total pounds of weight lost
大体时间：12 months
|
12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Weight loss of 5% of initial weight
大体时间：12 months
|
12 months
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Improvements in eating and physical activity habits
大体时间：12 months
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238. Erratum In: JAMA. 2005 Jan 19;293(3):298. JAMA. 2005 Jan 19;293(3):293-4.
- Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
- Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Finkelstein E, Fiebelkorn lC, Wang G. The costs of obesity among full-time employees. Am J Health Promot. 2005 Sep-Oct;20(1):45-51. doi: 10.4278/0890-1171-20.1.45.
- Finkelstein EA, Brown DS, Wrage LA, Allaire BT, Hoerger TJ. Individual and aggregate years-of-life-lost associated with overweight and obesity. Obesity (Silver Spring). 2010 Feb;18(2):333-9. doi: 10.1038/oby.2009.253. Epub 2009 Aug 13.
- Finkelstein EA, Fiebelkorn IC, Wang G. State-level estimates of annual medical expenditures attributable to obesity. Obes Res. 2004 Jan;12(1):18-24. doi: 10.1038/oby.2004.4.
- Finkelstein EA, Ruhm CJ, Kosa KM. Economic causes and consequences of obesity. Annu Rev Public Health. 2005;26:239-57. doi: 10.1146/annurev.publhealth.26.021304.144628.
- Finkelstein EA, Trogdon JG, Brown DS, Allaire BT, Dellea PS, Kamal-Bahl SJ. The lifetime medical cost burden of overweight and obesity: implications for obesity prevention. Obesity (Silver Spring). 2008 Aug;16(8):1843-8. doi: 10.1038/oby.2008.290. Epub 2008 May 29.
- Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
- Cai L, Lubitz J, Flegal KM, Pamuk ER. The predicted effects of chronic obesity in middle age on medicare costs and mortality. Med Care. 2010 Jun;48(6):510-7. doi: 10.1097/MLR.0b013e3181dbdb20.
- Stewart ST, Cutler DM, Rosen AB. Forecasting the effects of obesity and smoking on U.S. life expectancy. N Engl J Med. 2009 Dec 3;361(23):2252-60. doi: 10.1056/NEJMsa0900459.
- McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA. 1993 Nov 10;270(18):2207-12.
- McGinnis JM, Williams-Russo P, Knickman JR. The case for more active policy attention to health promotion. Health Aff (Millwood). 2002 Mar-Apr;21(2):78-93. doi: 10.1377/hlthaff.21.2.78.
- Schroeder SA. Shattuck Lecture. We can do better--improving the health of the American people. N Engl J Med. 2007 Sep 20;357(12):1221-8. doi: 10.1056/NEJMsa073350. No abstract available.
- Claxton G, DiJulio B, Whitmore H, Pickreign J, McHugh M, Finder B, Osei-Anto A. Job-based health insurance: costs climb at a moderate pace. Health Aff (Millwood). 2009 Nov-Dec;28(6):w1002-12. doi: 10.1377/hlthaff.28.6.w1002. Epub 2009 Sep 15.
- Heinen L, Darling H. Addressing obesity in the workplace: the role of employers. Milbank Q. 2009 Mar;87(1):101-22. doi: 10.1111/j.1468-0009.2009.00549.x.
- Finkelstein EA, Linnan LA, Tate DF, Birken BE. A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. J Occup Environ Med. 2007 Sep;49(9):981-9. doi: 10.1097/JOM.0b013e31813c6dcb.
- Volpp KG. Paying people to lose weight and stop smoking. LDI Issue Brief. 2009 Feb;14(3):1-4.
- Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
- Hallal PC, Victora CG. Reliability and validity of the International Physical Activity Questionnaire (IPAQ). Med Sci Sports Exerc. 2004 Mar;36(3):556. doi: 10.1249/01.mss.0000117161.66394.07. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2013年2月15日
首先提交符合 QC 标准的
2013年2月26日
首次发布 (估计)
2013年2月27日
研究记录更新
最后更新发布 (估计)
2015年5月6日
上次提交的符合 QC 标准的更新
2015年5月4日
最后验证
2013年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.