NCT01900392

Brief Summary

This study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
191

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 27, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

1.9 years

First QC Date

June 26, 2013

Results QC Date

June 21, 2018

Last Update Submit

September 26, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Change in Weight From Baseline to 6 Months

    6 months

  • Change in Weight From Baseline to 12 Months

    12 months

Study Arms (3)

Control Arm

NO INTERVENTION

No other financial incentive other than for the 3-, 6-, 9-, \& 12-month weigh-ins and surveys. Participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). Two weigh-ins will be required during Phase II, one at 9 months and the other at 12 months.

Direct payment

EXPERIMENTAL

In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible to receive an incentive for each day their goal is met during the first 6 months of the study. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.

Behavioral: Financial incentive

Lottery

EXPERIMENTAL

In addition to the incentives for the 3-, 6-, 9-, \& 12-month weigh-ins, participants who meet their daily goal will be eligible for the daily lottery during the first 6 months of the study. The expected daily winning for the lottery is the same as for the direct payment arm. All daily incentive earnings will be paid out after verifying participants' weights during an in person weigh in at a Weight Watchers location at months 3 and 6. Winnings will be proportional to weight loss. For example, if a participant's goal was to lose 6 pounds by month 3, but he/she only lost 3 pounds, that participant would only receive 50% of their total eligible winnings. Similar to the control arm, participants will receive daily feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weigh-ins at 9- and 12-months will also be required.

Behavioral: Financial incentive

Interventions

Financial incentiveBEHAVIORAL

Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.

Direct paymentLottery

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 30-80
  • BMI between 30 and 45 prior to starting Weight Watchers
  • Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling
  • Stable health

You may not qualify if:

  • Substance abuse
  • Bulimia nervosa or related behaviors
  • Pregnancy or breast feeding
  • Medical contraindications to counseling about diet, physical activity, or weight reduction
  • Unstable mental illness
  • Screen positive for pathological gambling on the basis of the 10 item DSM-IV criteria (excluded if meets 5 or more criteria)
  • Individuals unable to read consent forms or fill out surveys in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (21)

  • Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.

    PMID: 9813653BACKGROUND

  • Office of the Surgeon General (US); Office of Disease Prevention and Health Promotion (US); Centers for Disease Control and Prevention (US); National Institutes of Health (US). The Surgeon General's Call To Action To Prevent and Decrease Overweight and Obesity. Rockville (MD): Office of the Surgeon General (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK44206/

    PMID: 20669513BACKGROUND

  • Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

    PMID: 12365955BACKGROUND

  • 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.

    PMID: 16595758BACKGROUND

  • Adams KF, Schatzkin A, Harris TB, Kipnis V, Mouw T, Ballard-Barbash R, Hollenbeck A, Leitzmann MF. Overweight, obesity, and mortality in a large prospective cohort of persons 50 to 71 years old. N Engl J Med. 2006 Aug 24;355(8):763-78. doi: 10.1056/NEJMoa055643. Epub 2006 Aug 22.

    PMID: 16926275BACKGROUND

  • Yan LL, Daviglus ML, Liu K, Stamler J, Wang R, Pirzada A, Garside DB, Dyer AR, Van Horn L, Liao Y, Fries JF, Greenland P. Midlife body mass index and hospitalization and mortality in older age. JAMA. 2006 Jan 11;295(2):190-8. doi: 10.1001/jama.295.2.190.

    PMID: 16403931BACKGROUND

  • Daviglus ML, Liu K, Yan LL, Pirzada A, Manheim L, Manning W, Garside DB, Wang R, Dyer AR, Greenland P, Stamler J. Relation of body mass index in young adulthood and middle age to Medicare expenditures in older age. JAMA. 2004 Dec 8;292(22):2743-9. doi: 10.1001/jama.292.22.2743.

    PMID: 15585734BACKGROUND

  • 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.

    PMID: 18535543BACKGROUND

  • Nordmann AJ, Nordmann A, Briel M, Keller U, Yancy WS Jr, Brehm BJ, Bucher HC. Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials. Arch Intern Med. 2006 Feb 13;166(3):285-93. doi: 10.1001/archinte.166.3.285.

    PMID: 16476868BACKGROUND

  • Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. doi: 10.1001/jama.297.9.969.

    PMID: 17341711BACKGROUND

  • Methods for voluntary weight loss and control. NIH Technology Assessment Conference Panel. Consensus Development Conference, 30 March to 1 April 1992. Ann Intern Med. 1993 Oct 1;119(7 Pt 2):764-70.

    PMID: 8363212BACKGROUND

  • Giuffrida A, Torgerson DJ. Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ. 1997 Sep 20;315(7110):703-7. doi: 10.1136/bmj.315.7110.703.

    PMID: 9314754BACKGROUND

  • Kane RL, Johnson PE, Town RJ, Butler M. A structured review of the effect of economic incentives on consumers' preventive behavior. Am J Prev Med. 2004 Nov;27(4):327-52. doi: 10.1016/j.amepre.2004.07.002.

    PMID: 15488364BACKGROUND

  • Volpp KG, Gurmankin Levy A, Asch DA, Berlin JA, Murphy JJ, Gomez A, Sox H, Zhu J, Lerman C. A randomized controlled trial of financial incentives for smoking cessation. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):12-8. doi: 10.1158/1055-9965.EPI-05-0314.

    PMID: 16434580BACKGROUND

  • Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.

    PMID: 19213683BACKGROUND

  • 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.

    PMID: 19066383BACKGROUND

  • Flegal KM, Graubard BI, Williamson DF, Gail MH. Excess deaths associated with underweight, overweight, and obesity. JAMA. 2005 Apr 20;293(15):1861-7. doi: 10.1001/jama.293.15.1861.

    PMID: 15840860BACKGROUND

  • Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.

    PMID: 10546691BACKGROUND

  • The sixth report of the Joint National Committee on prevention, detection, evaluation, and treatment of high blood pressure. Arch Intern Med. 1997 Nov 24;157(21):2413-46. doi: 10.1001/archinte.157.21.2413.

    PMID: 9385294BACKGROUND

  • Eckel RH. Obesity and heart disease: a statement for healthcare professionals from the Nutrition Committee, American Heart Association. Circulation. 1997 Nov 4;96(9):3248-50. doi: 10.1161/01.cir.96.9.3248. No abstract available.

    PMID: 9386201BACKGROUND

  • Yancy WS Jr, Shaw PA, Reale C, Hilbert V, Yan J, Zhu J, Troxel AB, Foster GD, Volpp KG. Effect of Escalating Financial Incentive Rewards on Maintenance of Weight Loss: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914393. doi: 10.1001/jamanetworkopen.2019.14393.

    PMID: 31675083DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Catherine Reale
Organization
UPENN
catherine.reale@uphs.upenn.edu
2157464009

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 16, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

February 1, 2016

Last Updated

September 27, 2018

Results First Posted

September 27, 2018

Record last verified: 2018-09

Locations

US(1)