Financial Incentives for Weight Reduction Study

NCT03157713 | Completed DMC

• 1 other identifier: 5R01MD011544-03
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 2

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.

Conditions

Obese

Keywords

Obesity; Weight-loss; Financial Incentives; Behavioral Economics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Baseline and 6 months

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

  Baseline and 6 months

• Changes in Waist Circumference

  Baseline, 6 Months, 9 Months and 12 Months

• Changes in Blood Pressure

  Baseline, 6 Months, 9 Months and 12 Months

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

  6 months

Study Arms (3)

Goal-Directed

EXPERIMENTAL

Patients will receive enhanced usual care and also be informed that they will receive goal-directed financial incentives.

Behavioral: Goal-Directed Financial Incentives; Behavioral: Enhanced Usual Care

Outcome-Based

EXPERIMENTAL

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; Behavioral: Outcome-based Financial Incentives

Control-Enhanced Usual Care

OTHER

Patients will only receive enhanced usual care.

Behavioral: Enhanced Usual Care

Interventions

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).

Goal-Directed

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.

Control-Enhanced Usual Care; Goal-Directed; Outcome-Based

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.

Outcome-Based

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• New York University: collaborator

Study Sites (2)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

NYU Lutheran Medical Center

Brooklyn, New York, 11220, United States

Location

Related Publications (27)

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• Ladapo JA, Orstad SL, Wali S, Wylie-Rosett J, Tseng CH, Chung UYR, Cuevas MA, Hernandez C, Parraga S, Ponce R, Sweat V, Wittleder S, Wallach AB, Shu SB, Goldstein NJ, Jay M. Effectiveness of Goal-Directed and Outcome-Based Financial Incentives for Weight Loss in Primary Care Patients With Obesity Living in Socioeconomically Disadvantaged Neighborhoods: A Randomized Clinical Trial. JAMA Intern Med. 2023 Jan 1;183(1):61-69. doi: 10.1001/jamainternmed.2022.5618.

  PMID: 36469353 DERIVED

• Jay M, Orstad SL, Wali S, Wylie-Rosett J, Tseng CH, Sweat V, Wittleder S, Shu SB, Goldstein NJ, Ladapo JA. Goal-directed versus outcome-based financial incentives for weight loss among low-income patients with obesity: rationale and design of the Financial Incentives foR Weight Reduction (FIReWoRk) randomised controlled trial. BMJ Open. 2019 Apr 8;9(4):e025278. doi: 10.1136/bmjopen-2018-025278.

  PMID: 30962231 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Joseph A Ladapo, MD./PhD.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Melanie Jay, MD.

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 17, 2017
• Study Start: October 16, 2017
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)