Financial Incentives for Maintenance of Weight Loss

NCT ID: NCT01900392

Last Updated: 2018-09-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study participants will be obese volunteers recruited from a major community-based weight loss program (Weight Watchers), who have lost at least 5kg during the 4-6 months prior to enrolling in the study. Among these participants, the following will be assessed: 1. The effectiveness of a daily lottery-based financial incentive, relative to the control group, on weight loss and weight maintenance; 2. The effectiveness of a direct payment incentive, relative to the control group, on maintenance of weight loss; 3. Assess the comparative effectiveness of lottery-based and direct payment financial incentives on weight loss and maintenance; 4. The degree to which weight loss is maintained in the intervention groups relative to usual care during the 6 months following cessation of the intervention will also be determined.

During Phase I, incentives will be provided to some study participants (direct payment and lottery arm) for the first 6 months and subjects will be followed for 6 more months to examine effects following cessation of incentives.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Direct payment

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.

Group Type EXPERIMENTAL

Financial incentive

Intervention Type BEHAVIORAL

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

Lottery

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.

Group Type EXPERIMENTAL

Financial incentive

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Financial incentive

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9813653 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 20669513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12365955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16595758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16926275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16403931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15585734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18535543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16476868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17341711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8363212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9314754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15488364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16434580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19213683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19066383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15840860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10546691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9385294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9386201 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31675083 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01AG045045-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

816917

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motivations for Weight Loss
NCT00011115 COMPLETED NA
Dose-Response of Exercise on Long-Term Weight Loss
NCT00177762 COMPLETED PHASE1/PHASE2
Personalizing Financial Incentives
NCT07225426 NOT_YET_RECRUITING NA
Obesity and Financial Incentives
NCT01629576 UNKNOWN EARLY_PHASE1