- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01167634
University Of Pennsylvania Weight Loss Study
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
|
|
Experimental: 2
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: 24 Weeks
|
Change in weight between baseline and 24 weeks
|
24 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: George Loewenstein, PhD, Carnegie Mellon University
- Study Chair: Kevin G. Volpp, MD, PhD, University of Pennsylvania
- Study Director: Heather Schofield, MS, Harvard University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 813407
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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