ObesityNCT01800591
UPHS Weight Loss Study
A study testing Financial incentive in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this study is to compare a novel approach using financial incentives to changes in health benefit design and their impact on employee weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Financial incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults age 18-70
- BMI of 30 or above
Who cannot join
- Inability to consent
- Illiteracy and/or inability to speak, read, and write English
- Participation in another research study
- Conditions that would make participation unsafe:
- Current treatment for drug or alcohol use
- Consumption of at least 5 alcoholic drinks per day
Show all 15Show fewer
- Myocardial infarction or stroke within the past 6 months
- Current addiction to prescription medicines or street drugs
- Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)
- Pregnant or currently breastfeeding
- Diabetic and using any medicine besides metformin to control blood glucose
- 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
Official title: UPHS Weight Loss Study: Evaluating Methods to Use Health Benefits Design to Encourage Employee Weight Loss
The goal of this study is to compare a novel approach using financial incentives to changes in health benefit design and their impact on employee weight loss.
Read the detailed description
Employers are increasingly looking for opportunities to encourage weight loss among employees. While studies have shown that financial incentives can effectively encourage weight loss, little is known about their use in health benefits design. The goal of this study is to determine whether a financial incentive program delivered to obese University of Pennsylvania Health System employees can effectively encourage weight loss when compared to changes in health benefit design.
This is a randomized controlled trial involving financial incentives with four study arms: control, delayed gratification, immediate gratification, and financial incentive with frequent feedback. Participation in this study will last about 12 months.
The primary goal of the study is to test the effects of a novel financial incentive program using a lottery with frequent feedback to normal benefit design structures.
- Conditions
- Obesity
- Being tested
- Financial incentive
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentiveBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | No other financial incentive other than for enrollment, 6-month weigh in, and completion. |
| Delayed gratification | Experimental | In addition to the standard enrollment, 6-month, and completion incentives, if the subject loses 5% of their initial weight by the end of the study, they will receive an annual discount (distributed across bi-weekly pay periods) for 12 months beginning after the 12-month study ends. Their premium will return to normal price after this 12-month discount ends. Receives: Behavioral: Financial incentive |
| Immediate gratification | Experimental | In addition to the standard enrollment, 6-month, and completion incentives, the subject will be told that they can weigh in again any time before the study ends when they think they have lost 5% of their initial body weight. If they did meet their 5% goal, they will begin receiving a bi-weekly premium discount during the next pay period for a total duration of 12 months. Subjects that do not meet the 5% cut off during a weigh in are allowed to re-weigh themselves as many times as they like although they are encouraged to do so when they think they have met their target weight. Their premium goes back to normal price after this 12-month discount ends. Receives: Behavioral: Financial incentive |
| Financial incentive with frequent feedback | Experimental | In addition to the standard enrollment, 6-month, and completion incentives, the subject will be asked to weigh in on the IncentaHEALTH scales everyday they are at work. These subjects will participate in a daily lottery with the possibility of winning the same amount as the discount in Arms 2 and 3 over the course of the study. The subject can choose to select or be designated a two digit number that ranges from 00 to 99. Each day a lottery will be held and the subject will be given a 1% chance of matching both digits or an 18% chance of matching one digit. In order to get the lottery winnings, the subject must meet a weight goal that consistently decreases to accumulate to a 5% weight loss by the 6 month mark. After 6 months, the subject will receive the lottery winnings if they maintain that target weight (initial weight minus 5%) until the end of the 12-month study. Receives: Behavioral: Financial incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pounds of weight lost
Measured: 12 months
Secondary outcomes (1)
Weight loss of 5% of initial weight
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800591
- Sponsor's protocol ID
- 817128
- Status last verified
- Dec 2013
- First submitted
- 15 Feb 2013
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Finkelstein E, Fiebelkorn lC, Wang G. The costs of obesity among full-time employees. Am J Health Promot. 2005 Sep-Oct;20(1):45-51. doi: 10.4278/0890-1171-20.1.45.
PubMed 16171161Finkelstein EA, Brown DS, Wrage LA, Allaire BT, Hoerger TJ. Individual and aggregate years-of-life-lost associated with overweight and obesity. Obesity (Silver Spring). 2010 Feb;18(2):333-9. doi: 10.1038/oby.2009.253. Epub 2009 Aug 13.
PubMed 19680230Finkelstein EA, Fiebelkorn IC, Wang G. State-level estimates of annual medical expenditures attributable to obesity. Obes Res. 2004 Jan;12(1):18-24. doi: 10.1038/oby.2004.4.
PubMed 14742838Finkelstein EA, Ruhm CJ, Kosa KM. Economic causes and consequences of obesity. Annu Rev Public Health. 2005;26:239-57. doi: 10.1146/annurev.publhealth.26.021304.144628.
PubMed 15760288Finkelstein EA, Trogdon JG, Brown DS, Allaire BT, Dellea PS, Kamal-Bahl SJ. The lifetime medical cost burden of overweight and obesity: implications for obesity prevention. Obesity (Silver Spring). 2008 Aug;16(8):1843-8. doi: 10.1038/oby.2008.290. Epub 2008 May 29.
PubMed 18535543Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
PubMed 19635784Cai L, Lubitz J, Flegal KM, Pamuk ER. The predicted effects of chronic obesity in middle age on medicare costs and mortality. Med Care. 2010 Jun;48(6):510-7. doi: 10.1097/MLR.0b013e3181dbdb20.
PubMed 20473195Stewart ST, Cutler DM, Rosen AB. Forecasting the effects of obesity and smoking on U.S. life expectancy. N Engl J Med. 2009 Dec 3;361(23):2252-60. doi: 10.1056/NEJMsa0900459.
PubMed 19955525Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
PubMed 15010446McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA. 1993 Nov 10;270(18):2207-12.
PubMed 8411605McGinnis JM, Williams-Russo P, Knickman JR. The case for more active policy attention to health promotion. Health Aff (Millwood). 2002 Mar-Apr;21(2):78-93. doi: 10.1377/hlthaff.21.2.78.
PubMed 11900188Schroeder SA. Shattuck Lecture. We can do better--improving the health of the American people. N Engl J Med. 2007 Sep 20;357(12):1221-8. doi: 10.1056/NEJMsa073350. No abstract available.
PubMed 17881753Claxton G, DiJulio B, Whitmore H, Pickreign J, McHugh M, Finder B, Osei-Anto A. Job-based health insurance: costs climb at a moderate pace. Health Aff (Millwood). 2009 Nov-Dec;28(6):w1002-12. doi: 10.1377/hlthaff.28.6.w1002. Epub 2009 Sep 15.
PubMed 19755489Heinen L, Darling H. Addressing obesity in the workplace: the role of employers. Milbank Q. 2009 Mar;87(1):101-22. doi: 10.1111/j.1468-0009.2009.00549.x.
PubMed 19298417
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPHS Weight Loss Study: Evaluating Methods to Use Health Benefits Design to Encourage Employee Weight Loss
- ClinicalTrials.gov ID
- NCT01800591
- Acronym / sponsor ID
- 817128
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare a novel approach using financial incentives to changes in health benefit design and their impact on employee weight loss.
Detailed description
Employers are increasingly looking for opportunities to encourage weight loss among employees. While studies have shown that financial incentives can effectively encourage weight loss, little is known about their use in health benefits design. The goal of this study is to determine whether a financial incentive program delivered to obese University of Pennsylvania Health System employees can effectively encourage weight loss when compared to changes in health benefit design.
This is a randomized controlled trial involving financial incentives with four study arms: control, delayed gratification, immediate gratification, and financial incentive with frequent feedback. Participation in this study will last about 12 months.
The primary goal of the study is to test the effects of a novel financial incentive program using a lottery with frequent feedback to normal benefit design structures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –No other financial incentive other than for enrollment, 6-month weigh in, and completion. |
| Delayed gratification | Experimental | Behavioral: Financial incentiveIn addition to the standard enrollment, 6-month, and completion incentives, if the subject loses 5% of their initial weight by the end of the study, they will receive an annual discount (distributed across bi-weekly pay periods) for 12 months beginning after the 12-month study ends. Their premium will return to normal price after this 12-month discount ends. |
| Immediate gratification | Experimental | Behavioral: Financial incentiveIn addition to the standard enrollment, 6-month, and completion incentives, the subject will be told that they can weigh in again any time before the study ends when they think they have lost 5% of their initial body weight. If they did meet their 5% goal, they will begin receiving a bi-weekly premium discount during the next pay period for a total duration of 12 months. Subjects that do not meet the 5% cut off during a weigh in are allowed to re-weigh themselves as many times as they like although they are encouraged to do so when they think they have met their target weight. Their premium goes back to normal price after this 12-month discount ends. |
| Financial incentive with frequent feedback | Experimental | Behavioral: Financial incentiveIn addition to the standard enrollment, 6-month, and completion incentives, the subject will be asked to weigh in on the IncentaHEALTH scales everyday they are at work. These subjects will participate in a daily lottery with the possibility of winning the same amount as the discount in Arms 2 and 3 over the course of the study. The subject can choose to select or be designated a two digit number that ranges from 00 to 99. Each day a lottery will be held and the subject will be given a 1% chance of matching both digits or an 18% chance of matching one digit. In order to get the lottery winnings, the subject must meet a weight goal that consistently decreases to accumulate to a 5% weight loss by the 6 month mark. After 6 months, the subject will receive the lottery winnings if they maintain that target weight (initial weight minus 5%) until the end of the 12-month study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age 18-70
- BMI of 30 or above
Key exclusion criteria (15 listed)
- Inability to consent
- Illiteracy and/or inability to speak, read, and write English
- Participation in another research study
- Current treatment for drug or alcohol use
- Consumption of at least 5 alcoholic drinks per day
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 |
|---|---|---|
| Financial incentive | Behavioural | Delayed gratification, Financial incentive with frequent feedback, Immediate gratification |
Primary outcome
Total pounds of weight lost
Time frame: 12 months
1 secondary outcome
Weight loss of 5% of initial weight
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Background: PubMed 16171161Finkelstein E, Fiebelkorn lC, Wang G. The costs of obesity among full-time employees. Am J Health Promot. 2005 Sep-Oct;20(1):45-51. doi: 10.4278/0890-1171-20.1.45.
- Background: PubMed 19680230Finkelstein EA, Brown DS, Wrage LA, Allaire BT, Hoerger TJ. Individual and aggregate years-of-life-lost associated with overweight and obesity. Obesity (Silver Spring). 2010 Feb;18(2):333-9. doi: 10.1038/oby.2009.253. Epub 2009 Aug 13.
- Background: PubMed 14742838Finkelstein EA, Fiebelkorn IC, Wang G. State-level estimates of annual medical expenditures attributable to obesity. Obes Res. 2004 Jan;12(1):18-24. doi: 10.1038/oby.2004.4.
- Background: PubMed 15760288Finkelstein EA, Ruhm CJ, Kosa KM. Economic causes and consequences of obesity. Annu Rev Public Health. 2005;26:239-57. doi: 10.1146/annurev.publhealth.26.021304.144628.
- Background: PubMed 18535543Finkelstein EA, Trogdon JG, Brown DS, Allaire BT, Dellea PS, Kamal-Bahl SJ. The lifetime medical cost burden of overweight and obesity: implications for obesity prevention. Obesity (Silver Spring). 2008 Aug;16(8):1843-8. doi: 10.1038/oby.2008.290. Epub 2008 May 29.
- Background: PubMed 19635784Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
- Background: PubMed 20473195Cai L, Lubitz J, Flegal KM, Pamuk ER. The predicted effects of chronic obesity in middle age on medicare costs and mortality. Med Care. 2010 Jun;48(6):510-7. doi: 10.1097/MLR.0b013e3181dbdb20.
- Background: PubMed 19955525Stewart ST, Cutler DM, Rosen AB. Forecasting the effects of obesity and smoking on U.S. life expectancy. N Engl J Med. 2009 Dec 3;361(23):2252-60. doi: 10.1056/NEJMsa0900459.
- Background: PubMed 15010446Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. doi: 10.1001/jama.291.10.1238.
- Background: PubMed 8411605McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA. 1993 Nov 10;270(18):2207-12.
- Background: PubMed 11900188McGinnis JM, Williams-Russo P, Knickman JR. The case for more active policy attention to health promotion. Health Aff (Millwood). 2002 Mar-Apr;21(2):78-93. doi: 10.1377/hlthaff.21.2.78.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentive in people with Obesity, 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 15 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 6 May 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total pounds of weight lost (time frame: 12 months). 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 NCT01800591, which also lists 20 linked publications.
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 6 May 2015.