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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number105877
JournalContemporary Clinical Trials
Volume88
DOIs
StatePublished - Jan 2020

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Clinical Protocols
Cost-Benefit Analysis
Delivery of Health Care
Health Priorities
Health
Primary Care Physicians
Centers for Disease Control and Prevention (U.S.)
Administrative Personnel
Curriculum
Life Style
Weight Loss
Public Health
Interviews
Costs and Cost Analysis
Research
Mentoring

Keywords

  • Hybrid effectiveness-implementation trial
  • Prediabetes, diabetes prevention
  • RE-3AIM framework

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS) : A type 1 hybrid effectiveness-implementation trial protocol. / Almeida, Fabio A.; Michaud, Tzeyu L.; Wilson, Kathryn E.; Schwab, Robert J.; Goessl, Cody; Porter, Gwenndolyn C.; Brito, Fabiana A.; Evans, Greg; Dressler, Emily V.; Boggs, Ashley E.; Katula, Jeffrey A.; Sweet, Cynthia Castro; Estabrooks, Paul A.

In: Contemporary Clinical Trials, Vol. 88, 105877, 01.2020.

Research output: Contribution to journalArticle

Almeida, Fabio A. ; Michaud, Tzeyu L. ; Wilson, Kathryn E. ; Schwab, Robert J. ; Goessl, Cody ; Porter, Gwenndolyn C. ; Brito, Fabiana A. ; Evans, Greg ; Dressler, Emily V. ; Boggs, Ashley E. ; Katula, Jeffrey A. ; Sweet, Cynthia Castro ; Estabrooks, Paul A. / Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS) : A type 1 hybrid effectiveness-implementation trial protocol. In: Contemporary Clinical Trials. 2020 ; Vol. 88.
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