Microlearning Application for Diabetes Prevention | NCT05071820

Studies
Microlearning Application for Diabetes Prevention

NCT05071820

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Dec 10, 2024Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

PreDiabetes
Elevated Blood Sugar

Interventions

Health U mobile application
National Diabetes Prevention Program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The investigators decided to halt the study early because the company delivering the microlearning platform was incorporated into another company.

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Sep 28, 2023Actual

Completion Date

Sep 28, 2023Actual

First Submitted Date

Sep 28, 2021

First Submission Date that Met QC Criteria

Sep 28, 2021

First Posted Date

Oct 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sandra Anping Tsai, Clinical Associate Professor, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mobile application program	Experimental		Other: Health U mobile application
Traditional program	Active Comparator		Other: National Diabetes Prevention Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Health U mobile application	Other	Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application	Mobile application program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent weight lost at 12 months from baseline weight		12 months

Secondary Outcomes

Measure	Description	Time Frame
change in hemoglobin A1c		12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra A Tsai, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Health Care		Palo Alto	California	94304	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011236	Prediabetic State
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided