The Weigh Forward, Financial Incentives for Maintenance of Weight Loss

Obesity Clinical Trial

Official title:

A Randomized Trial of Financial Incentives for Maintenance of Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538783
• Other study ID #: 823005
• Secondary ID: 1R01AG045045-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: August 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: April 30, 2018
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Duke University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. Epub 2006 Aug 22. — View 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. Review. Erratum in: Obes Res 1998 Nov;6(6):464. — View 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. — View 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. — 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

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. — View 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. — View 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. Erratum in: JAMA. 2007 Jul 11;298(2):178. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. Erratum in: Arch Intern Med. 2006 Apr 24;166(8):932. — View 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. — 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

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. Erratum in: Arch Intern Med 1998 Mar 23;158(6):573. — View 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. — 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, 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight, Baseline and 6 Months	Among participants who lost 5 kg or more of baseline weight prior to randomization, assess the effectiveness of escalating lottery rewards, relative to the control group, on maintenance of weight loss after 6 months of intervention	6 months
Primary	Change in Weight, 6 Months and 12 Months	Among participants who lost 5 kg or more of baseline weight prior to randomization, assess the degree to which weight loss is maintained in the intervention groups relative to usual care during the 6 months following the cessation of the interventions	12 months