Financial Incentives for Weight Reduction Study (FIReWoRk)

May 25, 2023 updated by: Soma Wali, University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

668

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sylmar, California, United States, 91342
        • Olive View-UCLA Medical Center
    • New York
      • Brooklyn, New York, United States, 11220
        • NYU Lutheran Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
Time Frame: Baseline and 6 months
Assessed using SF-12v2 survey.
Baseline and 6 months
Change in Quality of Life Measured by EQ5-5D-5L
Time Frame: Baseline and 6 months
Assessed using EQ-5D-5L questionnaire.
Baseline and 6 months
Changes in Waist Circumference
Time Frame: Baseline, 6 Months, 9 Months and 12 Months
Measured using a standard tape measure
Baseline, 6 Months, 9 Months and 12 Months
Changes in Blood Pressure
Time Frame: Baseline, 6 Months, 9 Months and 12 Months
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.
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 months
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.
9 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

New York University

Investigators

  • Principal Investigator: Joseph A Ladapo, MD./PhD., University of California, Los Angeles
  • Principal Investigator: Melanie Jay, MD., New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2017

Primary Completion (Actual)

March 22, 2021

Study Completion (Actual)

March 22, 2021

Study Registration Dates

First Submitted

May 9, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5R01MD011544-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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