Overview

This trial is active, not recruiting.

Condition weight loss
Treatments deposit contract with a 1:1 match, deposit contract with a 2:1 match, deposit contract with no match
Phase phase 3
Sponsor University of Pennsylvania
Collaborator Carnegie Mellon University
Start date April 2011
End date December 2016
Trial size 132 participants
Trial identifier NCT01167634, 813407

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
(Experimental)
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.
(Experimental)
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.
(Experimental)
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.

Primary Outcomes

Measure
Change in weight
time frame: 24 Weeks

Secondary Outcomes

Measure
Average daily deposit value
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title University Of Pennsylvania Weight Loss Study
Principal investigator Jeffrey T Kullgren, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.