Financial Incentives for Weight Reduction Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Financial Incentive Strategies for Weight Loss in Obese Patients Living in Socioeconomically Disadvantaged Neighborhoods

Conditions
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Obese

Intervention / Treatment
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* Behavioral: Goal-Directed Financial Incentives
* Behavioral: Enhanced Usual Care
* Behavioral: Outcome-based Financial Incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal-Directed<br>Patients will receive enhanced usual care and also be informed that they will receive goal-directed financial incentives. | Behavioral: Goal-Directed Financial Incentives<br>* 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).<br>Behavioral: Enhanced Usual Care<br>* 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.<br>|
| Experimental: Outcome-Based<br>Patients will receive enhanced usual care and be informed that they will receive outcome-based financial incentives for significant weight losses. | Behavioral: Enhanced Usual Care<br>* 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.<br>Behavioral: Outcome-based Financial Incentives<br>* 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.<br>|
| Other: Control-Enhanced Usual Care<br>Patients will only receive enhanced usual care. | Behavioral: Enhanced Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life measured by 12-Item Short Form Survey (Version 2). | Assessed using SF-12v2 survey. | Baseline and 6 months | 
| Change in Quality of Life Measured by EQ5-5D-5L | Assessed using EQ-5D-5L questionnaire. | Baseline and 6 months | 
| Changes in Waist Circumference | Measured using a standard tape measure | Baseline, 6 Months, 9 Months and 12 Months | 
| Changes in Blood Pressure | Assessed using an automated sphygmomanometer | 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. | 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight-loss, Financial Incentives, Behavioral Economics