UPHS Weight Loss Study

Obesity Clinical Trial

Official title:

UPHS Weight Loss Study: Evaluating Methods to Use Health Benefits Design to Encourage Employee Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800591
• Other study ID #: 817128
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: May 4, 2015
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: December 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: University of Pennsylvania: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults age 18-70

• BMI of 30 or above

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Financial incentive

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (20)

Cai 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. — View Citation

Claxton 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. — View Citation

Finkelstein E, Fiebelkorn lC, Wang G. The costs of obesity among full-time employees. Am J Health Promot. 2005 Sep-Oct;20(1):45-51. — View Citation

Finkelstein 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. — View Citation

Finkelstein EA, Fiebelkorn IC, Wang G. State-level estimates of annual medical expenditures attributable to obesity. Obes Res. 2004 Jan;12(1):18-24. — View Citation

Finkelstein EA, Linnan LA, Tate DF, Birken BE. A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. J Occup Environ Med. 2007 Sep;49(9):981-9. — View Citation

Finkelstein EA, Ruhm CJ, Kosa KM. Economic causes and consequences of obesity. Annu Rev Public Health. 2005;26:239-57. Review. — View Citation

Finkelstein 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. — View Citation

Finkelstein 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. — View Citation

Hallal PC, Victora CG. Reliability and validity of the International Physical Activity Questionnaire (IPAQ). Med Sci Sports Exerc. 2004 Mar;36(3):556. — View Citation

Heinen 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. — View Citation

McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA. 1993 Nov 10;270(18):2207-12. — View Citation

McGinnis 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. Review. — View Citation

Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. Review. Erratum in: JAMA. 2005 Jan 19;293(3):298. JAMA. 2005 Jan 19;293(3):293-4. — View Citation

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. — View Citation

Schroeder 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. — View Citation

Stewart 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. — View Citation

Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. — View Citation

Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804. — View Citation

Volpp KG. Paying people to lose weight and stop smoking. LDI Issue Brief. 2009 Feb;14(3):1-4. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvements in eating and physical activity habits		12 months	No
Primary	Total pounds of weight lost		12 months	No
Secondary	Weight loss of 5% of initial weight		12 months	No