NCT02538783

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
259

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started May 2016

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

August 31, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 14, 2019

Completed
Last Updated

January 14, 2019

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

August 31, 2015

Results QC Date

November 14, 2018

Last Update Submit

January 11, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Control

NO INTERVENTION

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.

Escalating lottery

EXPERIMENTAL

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.

Behavioral: Escalating Lottery

Interventions

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

Escalating lottery

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
  • Have an online Weight Watchers membership

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 (19)

  • 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
  • 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

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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 2, 2015

Study Start

May 1, 2016

Primary Completion

November 13, 2017

Study Completion

April 30, 2018

Last Updated

January 14, 2019

Results First Posted

January 14, 2019

Record last verified: 2018-08

Locations