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NCT05071820 Clinical Trial

Microlearning Application for Diabetes Prevention

PreDiabetes Clinical Trial

Official title:
Validation of a Microlearning Approach to a Diabetes Prevention Program

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05071820
Other study ID # 61279
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date June 1, 2024

Study information
Verified date January 2023
Source Stanford University
Contact Sandra Tsa, MD
Phone 650-498-9000
Email stsai1@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 1, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 18 to 85 years old - high risk for type 2 diabetes (history of gestational diabetes, A1c 5.7-6.4) Exclusion Criteria: - pregnant - non-English speaker - not comfortable using a mobile application

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Health U mobile application
Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application
• National Diabetes Prevention Program
CDC recognized National DPP that follows a set curriculum with modules delivered over 12 months

Locations
Country Name City State
United States Stanford Health Care Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent weight lost at 12 months from baseline weight 12 months
Secondary change in hemoglobin A1c 12 months
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