Tzeyu L Michaud1, Paul A Estabrooks2, Wen You3, Todd J McGuire4, Fabio Almeida2, Kelly Karls5, Kenya Love6, Keyonna King2, Jennie Hill7, Jill Reed8, Gwenndolyn Porter9, Dejun Su2. 1. Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: tzeyu.michaud@unmc.edu. 2. Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA; Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. 3. Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA. 4. incentaHEALTH, LLC, Denver, CO, USA. 5. Fontenelle clinic, Nebraska Medicine, Omaha, Nebraska, NE, USA. 6. Center for Reducing Health Disparities, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. 7. Department of Epidemiology, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA. 8. College of Nursing, Kearney Division, University of Nebraska Medical Center, Omaha, NE, USA. 9. Department of Health Promotion, College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.
Abstract
BACKGROUND: High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap. PURPOSE: To describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business. METHODS: This study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m2, and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program. DISCUSSION: This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.
RCT Entities:
BACKGROUND:High attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap. PURPOSE: To describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business. METHODS: This study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m2, and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program. DISCUSSION: This study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.
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