University Of Pennsylvania Weight Loss Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Carnegie Mellon University
Harvard University
IncentaHEALTH
McKinsey & Company
Information provided by (Responsible Party):
Kevin Volpp, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01167634
First received: July 20, 2010
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 Intervention 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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: University Of Pennsylvania Weight Loss Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in weight [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average daily deposit value [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kevin Volpp, MD, MPH, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01167634     History of Changes
Other Study ID Numbers: 813407
Study First Received: July 20, 2010
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Weight Loss
Motivation
Contracts

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

ClinicalTrials.gov processed this record on October 19, 2014