Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol

Fabio A Almeida; Tzeyu L Michaud; Kathryn E Wilson; Robert J Schwab; Cody Goessl; Gwenndolyn C Porter; Fabiana A Brito; Greg Evans; Emily V Dressler; Ashley E Boggs; Jeffrey A Katula; Cynthia Castro Sweet; Paul A Estabrooks

doi:10.1016/j.cct.2019.105877

Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS): A type 1 hybrid effectiveness-implementation trial protocol

Contemp Clin Trials. 2020 Jan:88:105877. doi: 10.1016/j.cct.2019.105877. Epub 2019 Nov 1.

Authors

Affiliations

¹ Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States; Center for Reducing Health Disparities, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: Fabio.almeida@unmc.edu.
² Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States; Center for Reducing Health Disparities, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: tzeyu.michaud@unmc.edu.
³ Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: kathryn.wilson@unmc.edu.
⁴ Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: rjschwab@unmc.edu.
⁵ Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: cody.goessl@unmc.edu.
⁶ Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: gwenndolyn.porter@unmc.edu.
⁷ Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: fabiana.silva@unmc.edu.
⁸ Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27157, United States. Electronic address: gevans@wakehealth.edu.
⁹ Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27157, United States. Electronic address: Emily.Dressler@wakehealth.edu.
¹⁰ Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, United States. Electronic address: boggae17@wfu.edu.
¹¹ Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC 27109, United States. Electronic address: katulaj@wfu.edu.
¹² Medical Affairs, Omada Health, Inc., San Francisco, CA 94111, United States. Electronic address: cynthia@omadahealth.com.
¹³ Department of Health Promotion, University of Nebraska Medical Center, Omaha, NE 68198, United States; Center for Reducing Health Disparities, University of Nebraska Medical Center, Omaha, NE 68198, United States. Electronic address: paul.estabrooks@unmc.edu.

PMID: 31682941
DOI: 10.1016/j.cct.2019.105877

Abstract

Background: Diabetes prevention remains a top public health priority; digital approaches are potential solutions to existing scalability and accessibility challenges. There remains a gap in our understanding of the relationship between effectiveness, costs, and potential for sustained implementation of digital diabetes prevention strategies within typical healthcare settings.

Purpose: To describe the methods and design of a type 1 hybrid effectiveness-implementation trial of a digital diabetes prevention program (DPP) using the iPARIHS and RE-AIM frameworks.

Methods: The trial will contrast the effects of two DPP interventions: (1) small group, in-person class, and (2) a digital DPP consisting of small group support, personalized health coaching, digital tracking tools, and weekly behavior change curriculum. Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the CDC National DPP. Adults at risk for diabetes (BMI ≥25 and 5.7% ≤ HbA1c ≤ 6.4) will be randomly assigned to either the intervention group (n = 241) or the small group (n = 241). Assessment of primary (HbA1c) and secondary (weight loss, costs, cardiovascular risk factors) outcomes will occur at baseline, 4, and 12 months. Additionally, the trial will explore the potential for future adoption, implementation, and sustainability of the digitally-based intervention within a regional healthcare system based on key informant interviews and assessments of organizational administrators and primary care physicians.

Conclusion: This trial of a digital DPP will allow the research team to determine the relationships between reach, effectiveness, implementation, and costs.

Keywords: Hybrid effectiveness-implementation trial; Prediabetes, diabetes prevention; RE-3AIM framework.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Behavior Therapy*
Diabetes Mellitus, Type 2 / metabolism
Diabetes Mellitus, Type 2 / prevention & control*
Glycated Hemoglobin / metabolism
Humans
Implementation Science*
Internet-Based Intervention*
Mentoring*
Randomized Controlled Trials as Topic
Research Design
Risk Reduction Behavior*
Single-Blind Method
Social Support*
Treatment Outcome

Substances

Glycated Hemoglobin A
hemoglobin A1c protein, human