The Weigh Forward, Financial Incentives for Maintenance of Weight Loss

NCT ID: NCT02538783

Last Updated: 2019-01-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2018-04-30

Brief Summary

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

Detailed Description

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The study will evaluate the effectiveness of financial incentives in improving maintenance of weight loss. The investigators propose a 2-arm randomized controlled trial in which 258 participants who lose at least 5 kgs in a weight loss program will be randomized to one of the following: 1) daily weigh-ins and weekly feedback, 2) daily weigh-ins,weekly feedback, and a weekly escalating lottery-based financial incentive.

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. Upon enrollment, these participants will have an active online membership with Weight Watchers. Among these participants, the following will be assessed: 1. Assess the effectiveness of escalating lottery rewards, relative to the control group, on maintenance of weight loss over the ensuing 6 months (Phase I); 2.The degree to which weight loss is maintained in the intervention group relative to usual care during the 6 months following the cessation of the interventions (Phase II).

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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. No financial incentive other than for the midpoint and end of study surveys will be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Escalating lottery

Participants will receive weekly tips and weekly feedback for months 1-6 and will be observed without intervention in Phase II (months 7-12). The weekly feedback will pertain to whether or not the participant met his/her goal of weighing at least 6/7 days. The weekly tips will give information and suggestions on how to make it easier to weigh-in most days of the week. In addition to the incentives for midpoint and end of study surveys, participants who meet their weekly goal (weighing in 6 of 7 days) will be eligible for the weekly lottery during the first 6 months of the study. The expected weekly winning for the lottery is $3.55 in week 1 and this expected value will increase by $0.43 per week for each week the participant achieves their goal of weighing 6/7 days. All incentive earnings will be paid out on a monthly basis.

Group Type EXPERIMENTAL

Escalating Lottery

Intervention Type BEHAVIORAL

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

Interventions

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Escalating Lottery

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* Have an online Weight Watchers membership

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

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Duke University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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
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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)

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
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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)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01AG045045-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

823005

Identifier Type: -

Identifier Source: org_study_id

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