University Of Pennsylvania Weight Loss Study

Weight Loss Clinical Trial

Official title:

University Of Pennsylvania Weight Loss Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167634
• Other study ID #: 813407
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: August 22, 2017
• Start date: May 24, 2011
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2016
• Est. primary completion date: March 15, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	Carnegie Mellon University, Harvard University, incentaHEALTH, McKinsey & Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kullgren JT, Troxel AB, Loewenstein G, Norton LA, Gatto D, Tao Y, Zhu J, Schofield H, Shea JA, Asch DA, Pellathy T, Driggers J, Volpp KG. A Randomized Controlled Trial of Employer Matching of Employees' Monetary Contributions to Deposit Contracts to Promote Weight Loss. Am J Health Promot. 2016 Jul;30(6):441-52. doi: 10.1177/0890117116658210. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Change in weight between baseline and 24 weeks	24 Weeks