Microlearning Application for Diabetes Prevention
Primary Purpose
PreDiabetes, Elevated Blood Sugar
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health U mobile application
National Diabetes Prevention Program
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes
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:
- pregnant
- non-English speaker
- not comfortable using a mobile application
Sites / Locations
- Stanford Health CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile application program
Traditional program
Arm Description
Outcomes
Primary Outcome Measures
Percent weight lost at 12 months from baseline weight
Secondary Outcome Measures
change in hemoglobin A1c
Full Information
NCT ID
NCT05071820
First Posted
September 28, 2021
Last Updated
January 17, 2023
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT05071820
Brief Title
Microlearning Application for Diabetes Prevention
Official Title
Validation of a Microlearning Approach to a Diabetes Prevention Program
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Elevated Blood Sugar
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile application program
Arm Type
Experimental
Arm Title
Traditional program
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Health U mobile application
Intervention Description
Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application
Intervention Type
Other
Intervention Name(s)
National Diabetes Prevention Program
Intervention Description
CDC recognized National DPP that follows a set curriculum with modules delivered over 12 months
Primary Outcome Measure Information:
Title
Percent weight lost at 12 months from baseline weight
Time Frame
12 months
Secondary Outcome Measure Information:
Title
change in hemoglobin A1c
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
pregnant
non-English speaker
not comfortable using a mobile application
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Tsa, MD
Phone
650-498-9000
Email
stsai1@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra A Tsai, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra A Tsai, MD
Phone
650-498-9000
Email
stsai1@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Microlearning Application for Diabetes Prevention
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