Financial Incentives for Maintenance of Weight Loss

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Financial incentive

About this trial

This is an interventional health services research trial for Obesity

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Control Arm

Direct payment

Lottery

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Weight From Baseline to 6 Months

Change in Weight From Baseline to 12 Months

Secondary Outcome Measures

Full Information

NCT ID

NCT01900392

First Posted

June 26, 2013

Last Updated

September 26, 2018

Sponsor

University of Pennsylvania

Collaborators

Duke University, National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT01900392

Brief Title

Financial Incentives for Maintenance of Weight Loss

Official Title

A Randomized Trial of Financial Incentives for Maintenance of Weight Loss

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

Duke University, National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

191 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Arm

Arm Type

No Intervention

Arm Description

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.

Arm Title

Direct payment

Arm Type

Experimental

Arm Description

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.

Arm Title

Lottery

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Financial incentive

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Weight From Baseline to 6 Months

Time Frame

6 months

Title

Change in Weight From Baseline to 12 Months

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9813653

Citation

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. Erratum In: Obes Res 1998 Nov;6(6):464.

Results Reference

background

PubMed Identifier

20669513

Citation

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/

Results Reference

background

PubMed Identifier

12365955

Citation

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.

Results Reference

background

PubMed Identifier

16595758

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. doi: 10.1001/jama.295.13.1549.

Results Reference

background

PubMed Identifier

16926275

Citation

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.

Results Reference

background

PubMed Identifier

16403931

Citation

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.

Results Reference

background

PubMed Identifier

15585734

Citation

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.

Results Reference

background

PubMed Identifier

18535543

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.

Results Reference

background

PubMed Identifier

16476868

Citation

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. Erratum In: Arch Intern Med. 2006 Apr 24;166(8):932.

Results Reference

background

PubMed Identifier

17341711

Citation

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. Erratum In: JAMA. 2007 Jul 11;298(2):178.

Results Reference

background

PubMed Identifier

8363212

Citation

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.

Results Reference

background

PubMed Identifier

9314754

Citation

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.

Results Reference

background

PubMed Identifier

15488364

Citation

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.

Results Reference

background

PubMed Identifier

16434580

Citation

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.

Results Reference

background

PubMed Identifier

19213683

Citation

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.

Results Reference

background

PubMed Identifier

19066383

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.

Results Reference

background

PubMed Identifier

15840860

Citation

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.

Results Reference

background

PubMed Identifier

10546691

Citation

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.

Results Reference

background

PubMed Identifier

9385294

Citation

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. Erratum In: Arch Intern Med 1998 Mar 23;158(6):573.

Results Reference

background

PubMed Identifier

9386201

Citation

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.

Results Reference

background

PubMed Identifier

31675083

Citation

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.

Results Reference

derived

Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial