University Of Pennsylvania Weight Loss Study

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01167634
• Collaborator: Carnegie Mellon University (Other), Harvard University (Other), incentaHEALTH (Industry), McKinsey & Company (Other)
• Enrollment: 132
• Location: 1
• Arms: 4
• Actual Duration (Months): 61.3
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: University Of Pennsylvania Weight Loss Study
• Actual Study Start Date: May 24, 2011
• Actual Primary Completion Date: Mar 15, 2012
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Change in Weight [24 Weeks]

   Change in weight between baseline and 24 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01167634
• Other Study ID Numbers: 813407
• First Posted: Jul 22, 2010
• Last Update Posted: Aug 23, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by University of Pennsylvania: Weight Loss; Motivation; Contracts
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

Participant Flow

Arm/Group Title	1 - Control	2 - Deposit Contract With a 1:1 Match	3 - Deposit Contract With a 2:1 Match	Experimental 4 - Deposit With no Match
Arm/Group Description	Control - no financial incentive or match Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive.	Deposit contract with a 1:1 match 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 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 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.
Period Title: Overall Study
STARTED	33	33	33	33
COMPLETED	31	29	30	29
NOT COMPLETED	2	4	3	4

Baseline Characteristics

Arm/Group Title	1 - Control	2 - Deposit Contract With a 1:1 Match	3 - Deposit Contract With a 2:1 Match	Experimental 4 - Deposit With no Match	Total
Arm/Group Description	Deposit contract with a 1:1 match 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 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 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.	Total of all reporting groups
Overall Participants	33	33	33	33	132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (9.0)	44.3 (11.5)	42.0 (9.6)	43.5 (9.6)	43.9 (10.0)
Sex: Female, Male (Count of Participants)
Female	27 81.8%	30 90.9%	26 78.8%	32 97%	115 87.1%
Male	6 18.2%	3 9.1%	7 21.2%	1 3%	17 12.9%

Outcome Measures

1. Primary Outcome

Title	Change in Weight
Description	Change in weight between baseline and 24 weeks
Time Frame	24 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 - Control	2 - Deposit Contract With a 1:1 Match	3 - Deposit Contract With a 2:1 Match	Experimental 4 - Deposit With no Match
Arm/Group Description	Usual care arm	Deposit contract with a 1:1 match 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 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 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.
Measure Participants	33	33	33	33
Mean (Standard Deviation) [pounds]	1.0 (7.6)	-5.3 (10.1)	-2.3 (9.8)	-4.3 (8.9)

Adverse Events

Time Frame	Adverse Event data was collected during the intervention period from May 24, 2011 through March 15, 2012.
Arm/Group Title	1 - Control		2 - Deposit Contract With a 1:1 Match		3 - Deposit Contract With a 2:1 Match		Experimental 4 - Deposit Contract With no Match
Arm/Group Description	Control - no financial incentive or match Participants are given the goal of losing 1 pound per week for 24 weeks are asked to weigh-in monthly with no financial incentive.		Deposit contract with a 1:1 match 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 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 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.
All Cause Mortality
	1 - Control		2 - Deposit Contract With a 1:1 Match		3 - Deposit Contract With a 2:1 Match		Experimental 4 - Deposit Contract With no Match
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)		0/33 (0%)
Serious Adverse Events
	1 - Control		2 - Deposit Contract With a 1:1 Match		3 - Deposit Contract With a 2:1 Match		Experimental 4 - Deposit Contract With no Match
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	1 - Control		2 - Deposit Contract With a 1:1 Match		3 - Deposit Contract With a 2:1 Match		Experimental 4 - Deposit Contract With no Match
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)		0/33 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.