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Clinical Trials/NCT01167634
NCT01167634CompletedNot Applicable

University Of Pennsylvania Weight Loss Study

University of Pennsylvania2 sites in 1 country132 target enrollmentStarted: May 24, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
132
Locations
2
Primary Endpoint
Change in Weight

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

1

No Intervention

2

Experimental

Deposit contract with a 1:1 match

Intervention: Deposit contract with a 1:1 match (Behavioral)

3

Experimental

Deposit contract with a 2:1 match

Intervention: Deposit contract with a 2:1 match (Behavioral)

Experimental 4

Experimental

Deposit contract with no match

Intervention: Deposit Contract with no match (Behavioral)

Outcomes

Primary Outcomes

Change in Weight

Time Frame: 24 Weeks

Change in weight between baseline and 24 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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