PreDiabetesNCT05071820
Microlearning Application for Diabetes Prevention
A study testing Health U mobile application and National Diabetes Prevention Program in people with PreDiabetes and Elevated Blood Sugar, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a mobile application diabetes prevention program delivered with microlearning and microcoaching. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Elevated Blood Sugar
- What is being tested?
- Health U mobile application and National Diabetes Prevention Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 28 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 85 years old
- high risk for type 2 diabetes (history of gestational diabetes, A1c 5.7-6.4)
Who cannot join
- pregnant
- non-English speaker
- not comfortable using a mobile application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes, Elevated Blood Sugar
- Being tested
- Health U mobile application, National Diabetes Prevention Program
- Medical subject headings
- Prediabetic State, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health U mobile applicationOther
Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application
National Diabetes Prevention ProgramOther
CDC recognized National DPP that follows a set curriculum with modules delivered over 12 months
| Study group | Role | What they receive |
|---|---|---|
| Mobile application program | Experimental | Not described Receives: Other: Health U mobile application |
| Traditional program | Active comparator | Not described Receives: Other: National Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight lost at 12 months from baseline weight
Measured: 12 months
Secondary outcomes (1)
change in hemoglobin A1c
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Jan 2023
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Why it stopped: The investigators decided to halt the study early because the company delivering the microlearning platform was incorporated into another company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Anping Tsai, Stanford University
- Investigators
- Sandra A Tsai, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071820
- Sponsor's protocol ID
- 61279
- Status last verified
- Dec 2024
- First submitted
- 28 Sep 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Microlearning Approach to a Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT05071820
- Acronym / sponsor ID
- 61279
- Conditions
- PreDiabetes, Elevated Blood Sugar
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The investigators decided to halt the study early because the company delivering the microlearning platform was incorporated into another company.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile application program | Experimental | Other: Health U mobile application |
| Traditional program | Active comparator | Other: National Diabetes Prevention Program |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 85 years old
- high risk for type 2 diabetes (history of gestational diabetes, A1c 5.7-6.4)
Key exclusion criteria (3 listed)
- pregnant
- non-English speaker
- not comfortable using a mobile application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health U mobile applicationHealth U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application | Other | Mobile application program |
| National Diabetes Prevention ProgramCDC recognized National DPP that follows a set curriculum with modules delivered over 12 months | Other | Traditional program |
Primary outcome
Percent weight lost at 12 months from baseline weight
Time frame: 12 months
1 secondary outcome
change in hemoglobin A1c
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The investigators decided to halt the study early because the company delivering the microlearning platform was incorporated into another company.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra A Tsai, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health U mobile application and National Diabetes Prevention Program in people with PreDiabetes and Elevated Blood Sugar, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The investigators decided to halt the study early because the company delivering the microlearning platform was incorporated into another company.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent weight lost at 12 months from baseline weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.