Clinical trial NCT03157713: Financial Incentives for Weight Reduction Study
Official title: Financial Incentive Strategies for Weight Loss in Obese Patients Living in Socioeconomically Disadvantaged Neighborhoods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Keywords: Obesity
Weight-loss
Financial Incentives
Behavioral Economics
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: New York University
First posted: 2017-05-17
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who achieve 5% reduction from Baseline Weight at 6 months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in quality of life measured by 12-Item Short Form Survey (Version 2).
timeFrame: Baseline and 6 months
measure: Change in Quality of Life Measured by EQ5-5D-5L
timeFrame: Baseline and 6 months
measure: Changes in Waist Circumference
timeFrame: Baseline, 6 Months, 9 Months and 12 Months
measure: Changes in Blood Pressure
timeFrame: Baseline, 6 Months, 9 Months and 12 Months
measure: Use of evidenced-based weight loss programs assessed by documentation of enrollment.
timeFrame: 6 months
measure: Short term return on investment of using financial incentives to promote weight loss
timeFrame: 9 months
measure: Long term return on investment of using financial incentives to promote weight loss
timeFrame: 12 months
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Brooklyn
country: United States
facility: NYU Lutheran Medical Center
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Joseph A Ladapo, MD./PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Melanie Jay, MD.
role: PRINCIPAL_INVESTIGATOR
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