Clinical trial NCT01167634: University Of Pennsylvania Weight Loss Study
Official title: University Of Pennsylvania Weight Loss Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Weight Loss
Motivation
Contracts
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
name: Harvard University
name: incentaHEALTH
name: McKinsey & Company
First posted: 2010-07-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Weight
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin G. Volpp, MD, PhD
role: STUDY_CHAIR
affiliation: Carnegie Mellon University
name: George Loewenstein, PhD
role: STUDY_DIRECTOR
affiliation: Harvard University
name: Heather Schofield, MS
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Jeffrey T Kullgren, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.