ObeseFIReWoRkNCT03157713
Financial Incentives for Weight Reduction Study
A study testing Goal-Directed Financial Incentives and Outcome-based Financial Incentives in people with Obese, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Financial incentives for motivating changes in health behavior, particularly for weight loss in obese individuals, are increasingly being tested by health insurers, employers, and government agencies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obese
- What is being tested?
- Goal-Directed Financial Incentives and Outcome-based Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2017to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or Spanish-speaking patients
- Under the care of a primary care physician at Manhattan VA, Bellevue, NYU Langone Medical Center, or Olive View-UCLA Medical Center
- With obesity, based on BMI of 30 to 40 kg/m2 during a prior visit in the past 6 months
- Who are between the age of 18 and 70 years
- Who have an active U.S. phone number and address
Who cannot join
- have had weight loss ≥4.5 kg
- participated in an intensive weight loss program in the past 6 mo.
- abuse alcohol/other substances
- have active psychosis/other cognitive issues
- have history of myocardial infarction/stroke in the past 6 mo. or metastatic cancer
- New York Heart Association Class III/IV heart failure
Show all 10Show fewer
- Chronic Kidney Disease stage IV/V
- pregnant or breastfeeding or plan to become pregnant within subsequent 12 mo.
- have history of an eating disorder/unsafe weight-loss behaviors
- are unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Lutheran Medical Center
Brooklyn, New York, 11220
Olive View-UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: Financial Incentive Strategies for Weight Loss in Obese Patients Living in Socioeconomically Disadvantaged Neighborhoods
Financial incentives for motivating changes in health behavior, particularly for weight loss in obese individuals, are increasingly being tested by health insurers, employers, and government agencies. However, a key unanswered question regarding weight loss is how to structure these incentive programs to maximize their effectiveness, acceptability to patients, and economic sustainability. Focusing on obese patients living in neighborhoods with a high concentration of low socioeconomic status households, the investigators will compare the impact of financial incentives for weight loss on sustained weight loss, use of evidenced-based therapy, and quality of life, and they will determine their short-term and long-term return on investment.
Read the detailed description
Financial incentives for motivating changes in health behavior, for weight loss in obese individuals, are increasingly being tested by health insurers, employers, and government agencies. However, a key unanswered question regarding weight loss is how to structure these incentive programs to maximize their (1) effectiveness, underscored by the fact that most programs have not resulted in significant long-term weight loss; and (2) economic sustainability, as defined by their return on investment-a major factor in public and private decision-making.
Obese patients represent an important population to target for effective weight loss interventions because they suffer from a high prevalence of serious obesity-related illnesses-including diabetes, hypertension, dyslipidemia, heart disease, stroke, sleep apnea, and cancer-disproportionately have a low socioeconomic status, and impose $147 billion in costs on the healthcare system annually. While prior studies testing financial incentives in this population have had variable short-term success and few have yielded long-term weight loss, a fundamental question remains unanswered and may partially explain variability in weight loss outcomes: specifically, it is unknown whether goal-directed incentives (incentives for achieving evidence-based, intermediate goals that increase weight loss but are underutilized, like dietary counseling, physical activity, behavioral self-monitoring, and intensive weight management programs) or outcome-based incentives (like incentives for successfully losing weight) are more effective for promoting weight loss. Prior studies of weight loss incentives have largely emphasized only the latter.
The investigators propose a three-arm randomized controlled trial that will address this important knowledge gap among obese patients living in socioeconomically disadvantaged neighborhoods, with implications for other serious chronic health conditions. Comparing goal-directed incentives to outcome-based incentives and usual care, the investigators will assess their impact on weight loss (≥5% of baseline weight), use of evidenced-based therapy, and quality of life, and evaluate their short-term and long-term return on investment.
- Conditions
- Obese
- Being tested
- Goal-Directed Financial Incentives, Enhanced Usual Care, Outcome-based Financial Incentives
- Keywords
- Obesity, Weight-loss, Financial Incentives, Behavioral Economics
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Directed Financial IncentivesBehavioural
Patients will receive financial incentives for using a food diary, verified by entries in in the BookFactory Food Diary or another food diary, including internet/app-based diaries ($30 monthly); achieving 75 minutes of physical activity per week in first three months, as verified by a wearable fitness tracker ($20 monthly); achieving 150 minutes of physical activity per week in last three months, as verified by a wearable fitness tracker ($20 monthly); enrollment in a clinic-based or commercial weight loss program ($150 one time); and active participation in clinic-based or commercial weight loss program, as verified by the program ($60 monthly).
Enhanced Usual CareBehavioural
Patients will receive a food diary (BookFactory Food Diary), wearable fitness tracker (Fitbit), exercise and nutrition education materials (American Heart Association's Walking For Better Health and How to Eat Healthy), and referral information for intensive weight loss programs. This information will comprise these commercial and hospital-based weight loss programs that are evidence-based: Weight Watchers and Jenny Craig; the Veterans Administration's MOVE! and TeleMOVE! programs; Bellevue Hospital's Medical Weight Management Clinic and Intensive Nutritional Treatment programs; and New York University Langone Medical Center's Weight Management Program. We will also provide brief instructions on how to use the food diary and Fitbit Charge HR.
Outcome-based Financial IncentivesBehavioural
Patients will receive financial incentives for clinically significant weight loss, as confirmed at monthly weigh-ins. At 30 days, they will receive $50 if they lose ≥1.5% to <2.5% of baseline weight or $100 if they lose ≥2.5% of baseline weight. At 2 months and 3 months, they will receive $50 if they lose ≥2.5% to <5% of baseline weight or $100 if they lose ≥5% of baseline weight. At 4, 5, and 6 months, they will receive $100 if they lose ≥2.5% to <5% of baseline weight or $150 if they lose ≥5% of baseline weight. To employ the behavioral economic concept of regret aversion, patients will be given feedback at each assessment point about incentives they would have received had they achieved a loss of at least 2.5% of baseline weight.
| Study group | Role | What they receive |
|---|---|---|
| Goal-Directed | Experimental | Patients will receive enhanced usual care and also be informed that they will receive goal-directed financial incentives. Receives: Behavioral: Goal-Directed Financial Incentives; Behavioral: Enhanced Usual Care |
| Outcome-Based | Experimental | Patients will receive enhanced usual care and be informed that they will receive outcome-based financial incentives for significant weight losses. Receives: Behavioral: Enhanced Usual Care; Behavioral: Outcome-based Financial Incentives |
| Control-Enhanced Usual Care | Other | Patients will only receive enhanced usual care. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who achieve 5% reduction from Baseline Weight at 6 months
We will obtain weight measurements by weighing before eating without shoes or heavy garments using a digital scale that will be calibrated monthly.
Measured: Baseline and 6 months
Secondary outcomes (7)
Change in quality of life measured by 12-Item Short Form Survey (Version 2).
Assessed using SF-12v2 survey.
Measured: Baseline and 6 months
Change in Quality of Life Measured by EQ5-5D-5L
Assessed using EQ-5D-5L questionnaire.
Measured: Baseline and 6 months
Changes in Waist Circumference
Measured using a standard tape measure
Measured: Baseline, 6 Months, 9 Months and 12 Months
Changes in Blood Pressure
Assessed using an automated sphygmomanometer
Measured: Baseline, 6 Months, 9 Months and 12 Months
Use of evidenced-based weight loss programs assessed by documentation of enrollment.
Patients will have the option to either (1) provide consent for the investigators to contact and confirm enrollment and participation in evidence-based, commercial weight loss programs, or (2) procure documentation to confirm enrollment and participation.
Measured: 6 months
Short term return on investment of using financial incentives to promote weight loss
Cost analysis involving hospital utilization data, electronic health records, patient reported healthcare utilization, and micro-simulation modeling.
Measured: 9 months
Long term return on investment of using financial incentives to promote weight loss
Cost analysis involving hospital utilization data, electronic health records, patient reported healthcare utilization, and micro-simulation modeling.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start16 Oct 2017
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- New York University
- Responsible party
- Principal investigator, Soma Wali, University of California, Los Angeles
- Investigators
- Joseph A Ladapo, MD./PhD., Principal investigator, University of California, Los AngelesMelanie Jay, MD., Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157713
- Sponsor's protocol ID
- 5R01MD011544-03
- Acronym
- FIReWoRk
- Status last verified
- May 2023
- First submitted
- 9 May 2017
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gudzune KA, Doshi RS, Mehta AK, Chaudhry ZW, Jacobs DK, Vakil RM, Lee CJ, Bleich SN, Clark JM. Efficacy of commercial weight-loss programs: an updated systematic review. Ann Intern Med. 2015 Apr 7;162(7):501-12. doi: 10.7326/M14-2238.
PubMed 25844997Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Nonas CA, Sacks FM, Smith SC Jr, Svetkey LP, Wadden TA, Yanovski SZ, Kendall KA, Morgan LC, Trisolini MG, Velasco G, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S76-99. doi: 10.1161/01.cir.0000437740.48606.d1. Epub 2013 Nov 12. No abstract available.
PubMed 24222015Boutelle KN, Kirschenbaum DS. Further support for consistent self-monitoring as a vital component of successful weight control. Obes Res. 1998 May;6(3):219-24. doi: 10.1002/j.1550-8528.1998.tb00340.x.
PubMed 9618126Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Med Care. 2004 Sep;42(9):851-9. doi: 10.1097/01.mlr.0000135827.18610.0d.
PubMed 15319610Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
PubMed 11491192Murphy SL. Review of physical activity measurement using accelerometers in older adults: considerations for research design and conduct. Prev Med. 2009 Feb;48(2):108-14. doi: 10.1016/j.ypmed.2008.12.001. Epub 2008 Dec 10.
PubMed 19111780Strickland S. Does it work to pay people to live healthier lives? BMJ. 2014 Apr 2;348:g2458. doi: 10.1136/bmj.g2458. No abstract available.
PubMed 24696175Towers Watson National Business Group on Health. Full Report: Towers Watson/NBGH 2013/2014 Employer Survey on Purchasing Value in Health Care. 2014; http://www.towerswatson.com/en-US/Insights/IC-Types/Survey-Research-Results/2014/05/full-report-towers-watson-nbgh-2013-2014-employer-survey-on-purchasing-value-in-health-care. Accessed August 4, 2015.
Leatherman S, Berwick D, Iles D, Lewin LS, Davidoff F, Nolan T, Bisognano M. The business case for quality: case studies and an analysis. Health Aff (Millwood). 2003 Mar-Apr;22(2):17-30. doi: 10.1377/hlthaff.22.2.17.
PubMed 12674405Nguyen NT, Magno CP, Lane KT, Hinojosa MW, Lane JS. Association of hypertension, diabetes, dyslipidemia, and metabolic syndrome with obesity: findings from the National Health and Nutrition Examination Survey, 1999 to 2004. J Am Coll Surg. 2008 Dec;207(6):928-34. doi: 10.1016/j.jamcollsurg.2008.08.022. Epub 2008 Oct 10.
PubMed 19183541Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. doi: 10.1016/S0140-6736(05)67483-1.
PubMed 16198769Drewnowski A, Rehm CD, Solet D. Disparities in obesity rates: analysis by ZIP code area. Soc Sci Med. 2007 Dec;65(12):2458-63. doi: 10.1016/j.socscimed.2007.07.001. Epub 2007 Aug 29.
PubMed 17761378Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27.
PubMed 19635784John LK, Loewenstein G, Troxel AB, Norton L, Fassbender JE, Volpp KG. Financial incentives for extended weight loss: a randomized, controlled trial. J Gen Intern Med. 2011 Jun;26(6):621-6. doi: 10.1007/s11606-010-1628-y. Epub 2011 Jan 20.
PubMed 21249462
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentive Strategies for Weight Loss in Obese Patients Living in Socioeconomically Disadvantaged Neighborhoods
- ClinicalTrials.gov ID
- NCT03157713
- Acronym / sponsor ID
- FIReWoRk / 5R01MD011544-03
- Conditions
- Obese
- Keywords
- Obesity, Weight-loss, Financial Incentives, Behavioral Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- New York University
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Financial incentives for motivating changes in health behavior, particularly for weight loss in obese individuals, are increasingly being tested by health insurers, employers, and government agencies. However, a key unanswered question regarding weight loss is how to structure these incentive programs to maximize their effectiveness, acceptability to patients, and economic sustainability. Focusing on obese patients living in neighborhoods with a high concentration of low socioeconomic status households, the investigators will compare the impact of financial incentives for weight loss on sustained weight loss, use of evidenced-based therapy, and quality of life, and they will determine their short-term and long-term return on investment.
Detailed description
Financial incentives for motivating changes in health behavior, for weight loss in obese individuals, are increasingly being tested by health insurers, employers, and government agencies. However, a key unanswered question regarding weight loss is how to structure these incentive programs to maximize their (1) effectiveness, underscored by the fact that most programs have not resulted in significant long-term weight loss; and (2) economic sustainability, as defined by their return on investment-a major factor in public and private decision-making.
Obese patients represent an important population to target for effective weight loss interventions because they suffer from a high prevalence of serious obesity-related illnesses-including diabetes, hypertension, dyslipidemia, heart disease, stroke, sleep apnea, and cancer-disproportionately have a low socioeconomic status, and impose $147 billion in costs on the healthcare system annually. While prior studies testing financial incentives in this population have had variable short-term success and few have yielded long-term weight loss, a fundamental question remains unanswered and may partially explain variability in weight loss outcomes: specifically, it is unknown whether goal-directed incentives (incentives for achieving evidence-based, intermediate goals that increase weight loss but are underutilized, like dietary counseling, physical activity, behavioral self-monitoring, and intensive weight management programs) or outcome-based incentives (like incentives for successfully losing weight) are more effective for promoting weight loss. Prior studies of weight loss incentives have largely emphasized only the latter.
The investigators propose a three-arm randomized controlled trial that will address this important knowledge gap among obese patients living in socioeconomically disadvantaged neighborhoods, with implications for other serious chronic health conditions. Comparing goal-directed incentives to outcome-based incentives and usual care, the investigators will assess their impact on weight loss (≥5% of baseline weight), use of evidenced-based therapy, and quality of life, and evaluate their short-term and long-term return on investment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Goal-Directed | Experimental | Behavioral: Goal-Directed Financial Incentives, Behavioral: Enhanced Usual CarePatients will receive enhanced usual care and also be informed that they will receive goal-directed financial incentives. |
| Outcome-Based | Experimental | Behavioral: Enhanced Usual Care, Behavioral: Outcome-based Financial IncentivesPatients will receive enhanced usual care and be informed that they will receive outcome-based financial incentives for significant weight losses. |
| Control-Enhanced Usual Care | Other | Behavioral: Enhanced Usual CarePatients will only receive enhanced usual care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English or Spanish-speaking patients
- Under the care of a primary care physician at Manhattan VA, Bellevue, NYU Langone Medical Center, or Olive View-UCLA Medical Center
- With obesity, based on BMI of 30 to 40 kg/m2 during a prior visit in the past 6 months
- Who are between the age of 18 and 70 years
- Who have an active U.S. phone number and address
Key exclusion criteria (10 listed)
- have had weight loss ≥4.5 kg
- participated in an intensive weight loss program in the past 6 mo.
- abuse alcohol/other substances
- have active psychosis/other cognitive issues
- have history of myocardial infarction/stroke in the past 6 mo. or metastatic cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-Directed Financial IncentivesPatients will receive financial incentives for using a food diary, verified by entries in in the BookFactory Food Diary or another food diary, including internet/app-based diaries ($30 monthly); achieving 75 minutes of physical activity per week in first three months, as verified by a wearable fitness tracker ($20 monthly); achieving 150 minutes of physical activity per week in last three months, as verified by a wearable fitness tracker ($20 monthly); enrollment in a clinic-based or commercial weight loss program ($150 one time); and active participation in clinic-based or commercial weight loss program, as verified by the program ($60 monthly). | Behavioural | Goal-Directed |
| Enhanced Usual CarePatients will receive a food diary (BookFactory Food Diary), wearable fitness tracker (Fitbit), exercise and nutrition education materials (American Heart Association's Walking For Better Health and How to Eat Healthy), and referral information for intensive weight loss programs. This information will comprise these commercial and hospital-based weight loss programs that are evidence-based: Weight Watchers and Jenny Craig; the Veterans Administration's MOVE! and TeleMOVE! programs; Bellevue Hospital's Medical Weight Management Clinic and Intensive Nutritional Treatment programs; and New York University Langone Medical Center's Weight Management Program. We will also provide brief instructions on how to use the food diary and Fitbit Charge HR. | Behavioural | Control-Enhanced Usual Care, Goal-Directed, Outcome-Based |
| Outcome-based Financial IncentivesPatients will receive financial incentives for clinically significant weight loss, as confirmed at monthly weigh-ins. At 30 days, they will receive $50 if they lose ≥1.5% to <2.5% of baseline weight or $100 if they lose ≥2.5% of baseline weight. At 2 months and 3 months, they will receive $50 if they lose ≥2.5% to <5% of baseline weight or $100 if they lose ≥5% of baseline weight. At 4, 5, and 6 months, they will receive $100 if they lose ≥2.5% to <5% of baseline weight or $150 if they lose ≥5% of baseline weight. To employ the behavioral economic concept of regret aversion, patients will be given feedback at each assessment point about incentives they would have received had they achieved a loss of at least 2.5% of baseline weight. | Behavioural | Outcome-Based |
Primary outcome
Percentage of patients who achieve 5% reduction from Baseline Weight at 6 months
Time frame: Baseline and 6 months
We will obtain weight measurements by weighing before eating without shoes or heavy garments using a digital scale that will be calibrated monthly.
7 secondary outcomes
Change in quality of life measured by 12-Item Short Form Survey (Version 2).
Time frame: Baseline and 6 months
Change in Quality of Life Measured by EQ5-5D-5L
Time frame: Baseline and 6 months
Changes in Waist Circumference
Time frame: Baseline, 6 Months, 9 Months and 12 Months
Changes in Blood Pressure
Time frame: Baseline, 6 Months, 9 Months and 12 Months
Use of evidenced-based weight loss programs assessed by documentation of enrollment.
Time frame: 6 months
Short term return on investment of using financial incentives to promote weight loss
Time frame: 9 months
Long term return on investment of using financial incentives to promote weight loss
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Background: PubMed 25844997Gudzune KA, Doshi RS, Mehta AK, Chaudhry ZW, Jacobs DK, Vakil RM, Lee CJ, Bleich SN, Clark JM. Efficacy of commercial weight-loss programs: an updated systematic review. Ann Intern Med. 2015 Apr 7;162(7):501-12. doi: 10.7326/M14-2238.
- Background: PubMed 24222015Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Nonas CA, Sacks FM, Smith SC Jr, Svetkey LP, Wadden TA, Yanovski SZ, Kendall KA, Morgan LC, Trisolini MG, Velasco G, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S76-99. doi: 10.1161/01.cir.0000437740.48606.d1. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 9618126Boutelle KN, Kirschenbaum DS. Further support for consistent self-monitoring as a vital component of successful weight control. Obes Res. 1998 May;6(3):219-24. doi: 10.1002/j.1550-8528.1998.tb00340.x.
- Background: PubMed 15319610Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Med Care. 2004 Sep;42(9):851-9. doi: 10.1097/01.mlr.0000135827.18610.0d.
- Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Background: PubMed 11491192Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
- Background: PubMed 19111780Murphy SL. Review of physical activity measurement using accelerometers in older adults: considerations for research design and conduct. Prev Med. 2009 Feb;48(2):108-14. doi: 10.1016/j.ypmed.2008.12.001. Epub 2008 Dec 10.
- Background: PubMed 24696175Strickland S. Does it work to pay people to live healthier lives? BMJ. 2014 Apr 2;348:g2458. doi: 10.1136/bmj.g2458. No abstract available.
- BackgroundTowers Watson National Business Group on Health. Full Report: Towers Watson/NBGH 2013/2014 Employer Survey on Purchasing Value in Health Care. 2014; http://www.towerswatson.com/en-US/Insights/IC-Types/Survey-Research-Results/2014/05/full-report-towers-watson-nbgh-2013-2014-employer-survey-on-purchasing-value-in-health-care. Accessed August 4, 2015.
- Background: PubMed 12674405Leatherman S, Berwick D, Iles D, Lewin LS, Davidoff F, Nolan T, Bisognano M. The business case for quality: case studies and an analysis. Health Aff (Millwood). 2003 Mar-Apr;22(2):17-30. doi: 10.1377/hlthaff.22.2.17.
- Background: PubMed 19183541Nguyen NT, Magno CP, Lane KT, Hinojosa MW, Lane JS. Association of hypertension, diabetes, dyslipidemia, and metabolic syndrome with obesity: findings from the National Health and Nutrition Examination Survey, 1999 to 2004. J Am Coll Surg. 2008 Dec;207(6):928-34. doi: 10.1016/j.jamcollsurg.2008.08.022. Epub 2008 Oct 10.
- Background: PubMed 16198769Haslam DW, James WP. Obesity. Lancet. 2005 Oct 1;366(9492):1197-209. doi: 10.1016/S0140-6736(05)67483-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A Ladapo, MD./PhD. principal investigator
University of California, Los Angeles
Melanie Jay, MD. principal investigator
New York University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Directed Financial Incentives and Outcome-based Financial Incentives in people with Obese, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who achieve 5% reduction from Baseline Weight at 6 months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157713, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.