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University Of Pennsylvania Weight Loss Study

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ClinicalTrials.gov Identifier: NCT01167634
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborators:
Carnegie Mellon University
Harvard University
incentaHEALTH
McKinsey & Company
Information provided by (Responsible Party):
University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Deposit contract with a 1:1 match Behavioral: Deposit contract with a 2:1 match Behavioral: Deposit Contract with no match Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: University Of Pennsylvania Weight Loss Study
Actual Study Start Date : May 24, 2011
Actual Primary Completion Date : March 15, 2012
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
Deposit contract with a 1:1 match
Behavioral: Deposit contract with a 1:1 match
Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.
Experimental: 3
Deposit contract with a 2:1 match
Behavioral: Deposit contract with a 2:1 match
Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.
Experimental: Experimental 4
Deposit contract with no match
Behavioral: Deposit Contract with no match
Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.



Primary Outcome Measures :
  1. Change in Weight [ Time Frame: 24 Weeks ]
    Change in weight between baseline and 24 weeks



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167634


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Carnegie Mellon University
Harvard University
incentaHEALTH
McKinsey & Company
Investigators
Study Chair: Kevin G. Volpp, MD, PhD University of Pennsylvania
Study Director: George Loewenstein, PhD Carnegie Mellon University
Study Director: Heather Schofield, MS Harvard University
Principal Investigator: Jeffrey T Kullgren, MD, MPH University of Pennsylvania

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01167634     History of Changes
Other Study ID Numbers: 813407
First Posted: July 22, 2010    Key Record Dates
Results First Posted: August 23, 2017
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by University of Pennsylvania:
Weight Loss
Motivation
Contracts

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes