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Clinical Trials/NCT05071820
NCT05071820
Terminated
Not Applicable

Validation of a Microlearning Approach to a Diabetes Prevention Program

Stanford University1 site in 1 country12 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Stanford University
Enrollment
12
Locations
1
Primary Endpoint
Percent weight lost at 12 months from baseline weight
Status
Terminated
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to test the effectiveness of a mobile application diabetes prevention program delivered with microlearning and microcoaching.

Detailed Description

Patients with prediabetes who are interested in joining a diabetes prevention program will be randomized to either the mobile application diabetes prevention program or the traditional diabetes prevention program, which is delivered as a mixed program of in-person and virtual sessions. Study participants in the mobile application version will download the Health U app from the Apple application store. The user will complete the daily microlearning modules and the health coach interactions within the Health U application. The 12-month diabetes prevention program will follow the widely clinically-validated CDC Get Active to Prevent T2 curriculum. For participants participating in the in-person version, they will complete the diabetes prevention program, which meets in-person and virtually approximately once every two weeks.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
September 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sandra Anping Tsai

Clinical Associate Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • 18 to 85 years old
  • high risk for type 2 diabetes (history of gestational diabetes, A1c 5.7-6.4)

Exclusion Criteria

  • non-English speaker
  • not comfortable using a mobile application

Outcomes

Primary Outcomes

Percent weight lost at 12 months from baseline weight

Time Frame: 12 months

Secondary Outcomes

  • change in hemoglobin A1c(12 months)

Study Sites (1)

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