Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives

Overview

The proposed study "Sustaining the Reach of a Scalable Weight Loss Intervention through Financial Incentives: an Exploratory Randomized Trial" seeks to assess how the use of different incentive strategies may reduce the initial attrition gap when implementing weight management in a primary care clinic predominantly serving African American patients through an innovative research-practice partnership involving primary care, research expertise, and a small business. The sample will include approximately 200 persons ages 19+ from Nebraska Medicine or the greater Omaha community. The inclusion criteria are (1) age 19+ years; (2) are obese (BMI >=30) or overweight (BMI >=25 yet smaller than 30); (3) have internet access.

Following the completion of an automated informed consent embedded within the program registration using a kiosk placed at the Fontenelle Clinic, we plan to conduct a 4-arm, pragmatic randomized controlled trial (RCT) that will randomly assign overweight/obese patients at the Nebraska Medicine Fontenelle clinic to one of four financial incentive conditions respectively tied to: weight loss, weigh-ins, weigh-ins and weight-loss, and incentive choice, following the completion of an automated informed consent embedded within the program registration and initial weigh-in. Participants will be followed for 3 and 6 months to assess program reach, sustaining the reach after initial weigh-in, and weight loss outcomes based on records on participant enrollment and subsequent weigh-ins automatically collected through a kiosk placed at the Fontenelle clinic.

Full Title of Study: “Sustaining the Reach of a Scalable Weight Loss Intervention Through Financial Incentives: an Exploratory Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2021

Interventions

  • Other: Financial incentives
    • Depending on their level of participation or weight loss outcomes, participants will have the opportunity to receive between $60-$120 (over 12 months), on average, regardless of program assignment. Regardless of which incentive program that participants are randomized to, they will receive the incentaHEALTH weight loss program intervention. incentaHEALTH is an technology-supported multi-component coaching intervention for weight loss includes a website, objective weight assessment using HIPAA-compliant kiosks, daily social cognitive theory-based email and text message support, and online access to health coaches. The intervention encourages increased intake of fruit, vegetables, lean protein, and complex carbohydrates while monitoring portion sizes.

Arms, Groups and Cohorts

  • Active Comparator: Weight loss incentive
    • Participants will receive incentive rewards based on WEIGHT LOSS outcomes.
  • Experimental: Weigh-in incentive
    • Participants will receive incentive rewards based on WEIGH-INs frequency
  • Experimental: Combination incentive
    • Participants will receive half of the incentive from WEIGHT LOSS and WEIGH-INs
  • Experimental: Choice option incentive
    • Participants will choose one out of the three incentive programs (Weight-loss, Weigh-ins, and Combination).

Clinical Trial Outcome Measures

Primary Measures

  • Sustaining the reach
    • Time Frame: 3, 6, and 12 months
    • Percentage of participants returning to weigh-in 3, 6, and 12 months after initial program registration

Secondary Measures

  • Weight loss
    • Time Frame: 3, 6, and 12 months
    • weight loss achieved at 3, 6 and 12 months
  • Clinical meaningful weight loss
    • Time Frame: 3, 6, and 12 months
    • Percentage of participants achieving clinically significant weight loss (percentage of patients who lost >3% or >5% of their initial bodyweight)

Participating in This Clinical Trial

Inclusion Criteria

  • Overweight or obese participants who are of 19 years or older and have internet access

Exclusion Criteria

  • Not meeting the inclusion criteria.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Nebraska
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dejun Su, Associate Professor and Director of the Center for Reducing Health Disparities – University of Nebraska
  • Overall Contact(s)
    • Tzeyu Michaud, PhD, 4028369195, tzeyu.michaud@unmc.edu

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