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Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)
The goal of this randomized controlled trial is to determine the efficacy of a digital diabetes prevention program for improving weight, glucose control, and secondary risk factors among people with prediabetes compared to an enhanced standard care plus wait-list control. Exploratory assessments of implementation facilitators and barriers will also be completed to determine strategies for integrating external diabetes-prevention interventions within healthcare settings.
Prediabetes is an increasingly prevalent condition, characterized by glucose levels that are above normal but below the threshold for diabetes. Previous studies have demonstrated that intensive lifestyle interventions targeting changes in diet, physical activity, sleep, and stress can reduce the risk of progressing from prediabetes to Type 2 diabetes. The Diabetes Prevention Recognition Program (DPRP) currently recognizes both in-person and online programs that meet requirements to deliver approved curriculum, provide health coaching and group support, and equip participants with behavioral skills and self-monitoring tools to support behavior change. While non-randomized trial data demonstrate that an online digital program was successful for producing meaningful weight loss and improved glucose control, the goal of this randomized, controlled trial is to definitively evaluate the efficacy of the program for improving weight, glucose control and secondary risk factors compared to current standard care for prediabetes. In addition, few trials have examined the implementation factors that could speed the uptake of efficacious diabetes prevention interventions for delivery in regular clinical practice. Qualitative information on key organizational stakeholders (e.g., physicians, office managers) will be gathered to provide information on perceptions of the online program characteristics, outcomes, and resources concurrently with strategies to promote adoption and implementation in health care settings.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
Yes
University of Nebraska Medical Center
Omaha, Nebraska, United States
Start Date
November 1, 2017
Primary Completion Date
April 30, 2020
Completion Date
August 31, 2020
Last Updated
February 23, 2021
598
ACTUAL participants
Online diabetes prevention program
BEHAVIORAL
Standard Care
BEHAVIORAL
Lead Sponsor
Omada Health, Inc.
Collaborators
NCT05119179
NCT06252038
NCT04943861
Data Source & Attribution
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