Preventing Diabetes With Digital Health & Coaching

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03312764
Study type	Interventional
Source	Omada Health, Inc.
Contact
Status	Completed
Phase	N/A
Start date	November 1, 2017
Completion date	August 31, 2020

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Preventing Diabetes With Digital Health and Coaching — PREDICTS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms