Microlearning Application for Diabetes Prevention

January 17, 2023 updated by: Sandra Anping Tsai, Stanford University

Validation of a Microlearning Approach to a Diabetes Prevention Program

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Health Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile application program
Other: Health U mobile application
Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application
Active Comparator: Traditional program
Other: National Diabetes Prevention Program
CDC recognized National DPP that follows a set curriculum with modules delivered over 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent weight lost at 12 months from baseline weight
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in hemoglobin A1c
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sandra A Tsai, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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