TY - JOUR
T1 - Preventing diabetes with digital health and coaching for translation and scalability (PREDICTS)
T2 - A type 1 hybrid effectiveness-implementation trial protocol
AU - Almeida, Fabio A.
AU - Michaud, Tzeyu L.
AU - Wilson, Kathryn E.
AU - Schwab, Robert J.
AU - Goessl, Cody
AU - Porter, Gwenndolyn C.
AU - Brito, Fabiana A.
AU - Evans, Greg
AU - Dressler, Emily V.
AU - Boggs, Ashley E.
AU - Katula, Jeffrey A.
AU - Sweet, Cynthia Castro
AU - Estabrooks, Paul A.
N1 - Funding Information:
Research reported in this publication was supported by Omada Health, San Francisco, CA, USA. The content is solely of the responsibility of the authors and does not necessarily represent the official views of Omada Health.
Funding Information:
We would like to acknowledge the entire UNMC and Wake Forest School of Medicine research team who has been instrumental in the development and implementation of the PREDICTS trial, including LuAnn Larson, Rachel Harper, Tristan Gilmore, Haydar Hasan, Carrie Fay, Priyanka Chaudhary, Thomas Ward, Jennifer Alquicira, Lindsay Thomsen, Sharalyn Steenson, Emiliane Pereira, Mariam Taiwo, Amanda Kis, Xiaolu Hou, Ashley Raposo-Hadley, Kaylee Schwasinger, Norah Winter, Tiffany Powell, Markisha Jackson, Kalynn Hamlin, Camia Sellers, Kumar Gaurav, Jessica Tran, Destiny Gamble, Akou Vei, Carol Kittel (WFSM), Amir Alexander (WFSM), Lea Harvin (WFSM), and Patty Davis (WFSM). Finally, we thank Dr. Carolyn Jasik, Amelia Daly, Nick Ziegler and Michael Kahn of Omada Health for their invaluable assistance in coordination of the delivery of the digital diabetes prevention program.
Publisher Copyright:
© 2019
PY - 2020/1
Y1 - 2020/1
N2 - 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.
AB - 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.
KW - Hybrid effectiveness-implementation trial
KW - Prediabetes, diabetes prevention
KW - RE-3AIM framework
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U2 - 10.1016/j.cct.2019.105877
DO - 10.1016/j.cct.2019.105877
M3 - Article
C2 - 31682941
AN - SCOPUS:85075161535
SN - 1551-7144
VL - 88
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 105877
ER -