Financial Incentives for Weight Reduction Study
- Conditions
- Obese
- Interventions
- Behavioral: Enhanced Usual CareBehavioral: Goal-Directed Financial IncentivesBehavioral: Outcome-based Financial Incentives
- Registration Number
- NCT03157713
- Lead Sponsor
- University of California, Los Angeles
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 668
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control-Enhanced Usual Care Enhanced Usual Care Patients will only receive enhanced usual care. Goal-Directed Goal-Directed Financial Incentives Patients will receive enhanced usual care and also be informed that they will receive goal-directed financial incentives. Goal-Directed Enhanced Usual Care Patients will receive enhanced usual care and also be informed that they will receive goal-directed financial incentives. Outcome-Based Enhanced Usual Care Patients will receive enhanced usual care and be informed that they will receive outcome-based financial incentives for significant weight losses. Outcome-Based Outcome-based Financial Incentives Patients will receive enhanced usual care and be informed that they will receive outcome-based financial incentives for significant weight losses.
- Primary Outcome Measures
Name Time Method Percentage of patients who achieve 5% reduction from Baseline Weight at 6 months 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.
- Secondary Outcome Measures
Name Time Method Changes in Blood Pressure Baseline, 6 Months, 9 Months and 12 Months Assessed using an automated sphygmomanometer
Use of evidenced-based weight loss programs assessed by documentation of enrollment. 6 months 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.
Change in Quality of Life Measured by EQ5-5D-5L Baseline and 6 months Assessed using EQ-5D-5L questionnaire.
Short term return on investment of using financial incentives to promote weight loss 9 months Cost analysis involving hospital utilization data, electronic health records, patient reported healthcare utilization, and micro-simulation modeling.
Long term return on investment of using financial incentives to promote weight loss 12 months Cost analysis involving hospital utilization data, electronic health records, patient reported healthcare utilization, and micro-simulation modeling.
Changes in Waist Circumference Baseline, 6 Months, 9 Months and 12 Months Measured using a standard tape measure
Change in quality of life measured by 12-Item Short Form Survey (Version 2). Baseline and 6 months Assessed using SF-12v2 survey.
Trial Locations
- Locations (2)
Olive View-UCLA Medical Center
🇺🇸Sylmar, California, United States
NYU Lutheran Medical Center
🇺🇸Brooklyn, New York, United States