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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG045045-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| National Institute on Aging (NIA) | NIH |
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This study aims to evaluate the effectiveness of financial incentives in improving and maintaining weight loss.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | 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. | |
| Direct payment | Experimental | 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. |
|
| Lottery | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentive | Behavioral | Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight From Baseline to 6 Months | 6 months | |
| Change in Weight From Baseline to 12 Months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9813653 | Background | 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. | |
| 20669513 | Background | 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/ |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight From Baseline to 6 Months | Posted | Mean | Standard Deviation | kilograms | 6 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysterectomy | Reproductive system and breast disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ganglion cyst outpatient surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Reale | UPENN | 2157464009 | catherine.reale@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 12365955 | Background | 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. |
| 16595758 | Background | 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. |
| 16926275 | Background | 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. |
| 16403931 | Background | 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. |
| 15585734 | Background | 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. |
| 18535543 | Background | 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. |
| 16476868 | Background | 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. |
| 17341711 | Background | 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. |
| 8363212 | Background | 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. |
| 9314754 | Background | 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. |
| 15488364 | Background | 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. |
| 16434580 | Background | 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. |
| 19213683 | Background | 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. |
| 19066383 | Background | 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. |
| 15840860 | Background | 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. |
| 10546691 | Background | 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. |
| 9385294 | Background | 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. |
| 9386201 | Background | 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. |
| 31675083 | Derived | 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. |
| BG001 | 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. |
| BG002 | Control | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Household income | Count of Participants | Participants |
|
| Household size | Mean | Standard Deviation | people per household |
|
| Education | Number | participants |
|
| Weight measures | Mean | Standard Deviation | Kilograms |
|
| BMI measures | Mean | Standard Deviation | kg/m^2 |
|
| BMI ≥35 kg/m2 at randomization | Count of Participants | Participants |
|
| Eating behaviors by Three-Factor Eating Questionnaire | The raw eating scale scores are transformed to a 0-100 scale [((raw score - lowest possible raw score)/possible raw score range) × 100] Higher scores in the respective scales are indicative of greater cognitive restraint, uncontrolled, or emotional eating | Mean | Standard Deviation | Scores on a scale |
|
| Physical activity in min per week | Median | Inter-Quartile Range | Minutes |
|
| OG002 | 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. |
|
|
|
| Primary | Change in Weight From Baseline to 12 Months | Posted | Mean | Standard Deviation | kilograms | 12 months |
|
|
|
| 0 |
| 77 |
| 2 |
| 77 |
| 2 |
| 77 |
| EG001 | 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. | 1 | 75 | 9 | 75 | 1 | 75 |
| EG002 | Control | 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. | 0 | 39 | 4 | 39 | 1 | 39 |
| Hip replacement | Surgical and medical procedures | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Brain aneurysm | Nervous system disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Ruptured appendix | Gastrointestinal disorders | Non-systematic Assessment |
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| Temporal artery biopsy | Surgical and medical procedures | Non-systematic Assessment |
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| Lymphoma | Vascular disorders | Non-systematic Assessment |
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| Syncope | Cardiac disorders | Non-systematic Assessment |
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| Angina | Cardiac disorders | Non-systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Breast cancer | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vascular surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Sciatica from car accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Broken foot | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Torn ACL and MCL, broken ankle | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |