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University Of Pennsylvania Weight Loss Study

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deposit contract with a 1:1 match
Deposit contract with a 2:1 match
Deposit Contract with no match
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Weight Loss, Motivation, Contracts

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

1

2

3

Experimental 4

Arm Description

Deposit contract with a 1:1 match

Deposit contract with a 2:1 match

Deposit contract with no match

Outcomes

Primary Outcome Measures

Change in Weight
Change in weight between baseline and 24 weeks

Secondary Outcome Measures

Full Information

First Posted
July 20, 2010
Last Updated
August 22, 2017
Sponsor
University of Pennsylvania
Collaborators
Carnegie Mellon University, Harvard University, incentaHEALTH, McKinsey & Company
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1. Study Identification

Unique Protocol Identification Number
NCT01167634
Brief Title
University Of Pennsylvania Weight Loss Study
Official Title
University Of Pennsylvania Weight Loss Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 24, 2011 (Actual)
Primary Completion Date
March 15, 2012 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Carnegie Mellon University, Harvard University, incentaHEALTH, McKinsey & Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Weight Loss, Motivation, Contracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Deposit contract with a 1:1 match
Arm Title
3
Arm Type
Experimental
Arm Description
Deposit contract with a 2:1 match
Arm Title
Experimental 4
Arm Type
Experimental
Arm Description
Deposit contract with no match
Intervention Type
Behavioral
Intervention Name(s)
Deposit contract with a 1:1 match
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Deposit contract with a 2:1 match
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Deposit Contract with no match
Intervention Description
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 Measure Information:
Title
Change in Weight
Description
Change in weight between baseline and 24 weeks
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin G. Volpp, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
George Loewenstein, PhD
Organizational Affiliation
Carnegie Mellon University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heather Schofield, MS
Organizational Affiliation
Harvard University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeffrey T Kullgren, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27445325
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.
Results Reference
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University Of Pennsylvania Weight Loss Study

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