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Completed

NCT Number: NCT03157713

Financial Incentives for Weight Reduction Study

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Olive View-UCLA Medical Center, Sylmar, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal-Directed Financial Incentives

Behavioral

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 Care

Behavioral

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 Incentives

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in quality of life measured by 12-Item Short Form Survey (Version 2).

    Time frame: Baseline and 6 months

    Assessed using SF-12v2 survey.

  2. Change in Quality of Life Measured by EQ5-5D-5L

    Time frame: Baseline and 6 months

    Assessed using EQ-5D-5L questionnaire.

  3. Changes in Waist Circumference

    Time frame: Baseline, 6 Months, 9 Months and 12 Months

    Measured using a standard tape measure

  4. Changes in Blood Pressure

    Time frame: Baseline, 6 Months, 9 Months and 12 Months

    Assessed using an automated sphygmomanometer

  5. Use of evidenced-based weight loss programs assessed by documentation of enrollment.

    Time frame: 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.

  6. Short term return on investment of using financial incentives to promote weight loss

    Time frame: 9 months

    Cost analysis involving hospital utilization data, electronic health records, patient reported healthcare utilization, and micro-simulation modeling.

  7. Long term return on investment of using financial incentives to promote weight loss

    Time frame: 12 months

    Cost analysis involving hospital utilization data, electronic health records, patient reported healthcare utilization, and micro-simulation modeling.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • New York University

Registry information

Official study title

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

Acronym: FIReWoRk

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 17, 2017
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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