Weight LossNCT01167634
University Of Pennsylvania Weight Loss Study
A study testing Deposit contract with a 1:1 match, Deposit contract with a 2:1 match and Deposit Contract with no match in people with Weight Loss, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Deposit contract with a 1:1 match, Deposit contract with a 2:1 match and Deposit Contract with no match
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2011to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 (inclusive)
- BMI between 30 and 50 (inclusive)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Weight Loss
- Being tested
- Deposit contract with a 1:1 match, Deposit contract with a 2:1 match, Deposit Contract with no match
- Keywords
- Weight Loss, Motivation, Contracts
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deposit contract with a 1:1 matchBehavioural
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 matchBehavioural
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 matchBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Deposit contract with a 1:1 match Receives: Behavioral: Deposit contract with a 1:1 match |
| 3 | Experimental | Deposit contract with a 2:1 match Receives: Behavioral: Deposit contract with a 2:1 match |
| Experimental 4 | Experimental | Deposit contract with no match Receives: Behavioral: Deposit Contract with no match |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Change in weight between baseline and 24 weeks
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study start24 May 2011
- Primary completion15 Mar 2012
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University, Harvard University, incentaHEALTH, McKinsey & Company
- Responsible party
- Sponsor
- Investigators
- Kevin G. Volpp, MD, PhD, Study chair, University of PennsylvaniaGeorge Loewenstein, PhD, Study director, Carnegie Mellon UniversityHeather Schofield, MS, Study director, Harvard UniversityJeffrey T Kullgren, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167634
- Sponsor's protocol ID
- 813407
- Status last verified
- Aug 2017
- First submitted
- 20 Jul 2010
- Last updated
- 23 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 27445325
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University Of Pennsylvania Weight Loss Study
- ClinicalTrials.gov ID
- NCT01167634
- Acronym / sponsor ID
- 813407
- Conditions
- Weight Loss
- Keywords
- Weight Loss, Motivation, Contracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Carnegie Mellon University, Harvard University, incentaHEALTH, McKinsey & Company
- Study start
- 24 May 2011 (actual)
- Primary completion
- 15 Mar 2012 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 23 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: Deposit contract with a 1:1 matchDeposit contract with a 1:1 match |
| 3 | Experimental | Behavioral: Deposit contract with a 2:1 matchDeposit contract with a 2:1 match |
| Experimental 4 | Experimental | Behavioral: Deposit Contract with no matchDeposit contract with no match |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 to 70 (inclusive)
- BMI between 30 and 50 (inclusive)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deposit contract with a 1:1 matchDaily 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. | Behavioural | 2 |
| Deposit contract with a 2:1 matchDaily 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. | Behavioural | 3 |
| Deposit Contract with no matchDaily 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. | Behavioural | Experimental 4 |
Primary outcome
Change in Weight
Time frame: 24 Weeks
Change in weight between baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27445325Kullgren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin G. Volpp, MD, PhD study chair
University of Pennsylvania
George Loewenstein, PhD study director
Carnegie Mellon University
Heather Schofield, MS study director
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deposit contract with a 1:1 match, Deposit contract with a 2:1 match and Deposit Contract with no match in people with Weight Loss, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01167634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.