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University Of Pennsylvania Weight Loss Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01167634
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Collaborators:
Carnegie Mellon University
Harvard University
incentaHEALTH
McKinsey & Company
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Weight Loss
Interventions Behavioral: Deposit contract with a 1:1 match
Behavioral: Deposit contract with a 2:1 match
Behavioral: Deposit Contract with no match
Enrollment 132
Recruitment Details  
Pre-assignment Details  
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
Hide 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
Reason Not Completed
Lost to Follow-up             1             3             3             4
Withdrawal by Subject             1             1             0             0
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
Hide Arm/Group Description [Not Specified]

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 Number of Baseline Participants 33 33 33 33 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 33 participants 33 participants 132 participants
45.9  (9.0) 44.3  (11.5) 42.0  (9.6) 43.5  (9.6) 43.9  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 33 participants 33 participants 132 participants
Female
27
  81.8%
30
  90.9%
26
  78.8%
32
  97.0%
115
  87.1%
Male
6
  18.2%
3
   9.1%
7
  21.2%
1
   3.0%
17
  12.9%
1.Primary Outcome
Title Change in Weight
Hide Description Change in weight between baseline and 24 weeks
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 33 33 33 33
Mean (Standard Deviation)
Unit of Measure: pounds
1.0  (7.6) -5.3  (10.1) -2.3  (9.8) -4.3  (8.9)
Time Frame Adverse Event data was collected during the intervention period from May 24, 2011 through March 15, 2012.
Adverse Event Reporting 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 Contract With no Match
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%) 
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%)   0/33 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laurie Norton
Organization: University of Pennsylvania School of Medicine
Phone: 2155738799 ext 215
EMail: lanorton@mail.med.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01167634    
Other Study ID Numbers: 813407
First Submitted: July 20, 2010
First Posted: July 22, 2010
Results First Submitted: May 1, 2017
Results First Posted: August 23, 2017
Last Update Posted: August 23, 2017