NCT05071820

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

September 28, 2021

Last Update Submit

December 5, 2024

Conditions

PreDiabetesElevated Blood Sugar

Outcome Measures

Primary Outcomes (1)

  • Percent weight lost at 12 months from baseline weight

    12 months

Secondary Outcomes (1)

  • change in hemoglobin A1c

    12 months

Study Arms (2)

Mobile application program

EXPERIMENTAL
Other: Health U mobile application

Traditional program

ACTIVE COMPARATOR
Other: National Diabetes Prevention Program

Interventions

Health U mobile applicationOTHER

Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application

Mobile application program
National Diabetes Prevention ProgramOTHER

CDC recognized National DPP that follows a set curriculum with modules delivered over 12 months

Traditional program

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Health Care

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Prediabetic StateHyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sandra A Tsai, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 8, 2021

Study Start

January 1, 2023

Primary Completion

September 28, 2023

Study Completion

September 28, 2023

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)