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临床试验/NCT01167634
NCT01167634已完成不适用

University Of Pennsylvania Weight Loss Study

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2011年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
Change in Weight

研究概览

简要总结

This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at a large health management company to participate in a 6-month weight loss program and have weight measurements for an additional 3-month follow-up period. The primary outcome measure in this randomized controlled trial will be pounds of weight lost. The experimental groups will include variations of deposit contracts (participants put their own money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed payments. The use of deposit contracts is a powerful mechanism for inducing behavior change that is based on loss aversion, a psychological concept first described by Nobel Prize winner Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the fact that people typically feel the pain of a loss more than the pleasure of a gain, increasing ones motivation to reach a goal.

The study hypotheses are 1) mean weight loss will be greater in all intervention groups compared to the control group by the end of 24 weeks; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 3-month follow-up period than individuals in the control group.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 to 70 (inclusive)
  • BMI between 30 and 50 (inclusive)

排除标准

  • Inability to consent
  • No known Illiteracy and/or inability to speak, read, and write English
  • Participation in another weight loss program
  • Participation in another research study
  • Current treatment for drug or alcohol use
  • Consumption of 5 alcoholic drinks per day
  • Myocardial infarction or stroke within the past 6 months
  • Uncontrolled hypertension (defined as BP170 mm Hg systolic or BP110 mm Hg diastolic)
  • Current addiction to prescription medicines or street drugs
  • Serious psychiatric diagnoses (severe depression, schizophrenia)
  • Pregnancy
  • Diabetic and using any medicine besides metformin to control blood sugars
  • 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

研究组 & 干预措施

1

No Intervention

2

Experimental

Deposit contract with a 1:1 match

干预措施: Deposit contract with a 1:1 match (Behavioral)

3

Experimental

Deposit contract with a 2:1 match

干预措施: Deposit contract with a 2:1 match (Behavioral)

Experimental 4

Experimental

Deposit contract with no match

干预措施: Deposit Contract with no match (Behavioral)

结局指标

主要结局

Change in Weight

时间窗: 24 Weeks

Change in weight between baseline and 24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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