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Can a phone app help stroke survivors avoid another stroke?

NCT ID NCT07120334

Disease control Sponsor: University of Hawaii Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a mobile app called PortionSize Ed can help recent stroke survivors who also have prediabetes or type 2 diabetes follow a Mediterranean-style diet. Forty adults aged 30 to 65 will be split into two groups: one gets the full app with dietitian support, the other gets a basic version. The goal is to see if the app is easy to use and if it improves diet and health markers like blood sugar and cholesterol.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PortionSize Ed app with Mediterranean diet support and registered dietitian counseling
What this could lead to
If successful, this app could offer a practical way for stroke survivors to improve their diet and potentially lower the risk of another stroke.
What could go wrong
This is a very small pilot study with only 40 people, so results may not apply to everyone. The app's effectiveness is still unproven, and participants may find it hard to stick with the program.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 30 to 65 years * Recent stroke (ischemic, hemorrhagic or Transient Ischemic Attack), within 1-14 days prior to enrollment * Confirmed diagnosis of prediabetes or type 2 diabetes, based on HbA1c results * Medically stable and cleared for oral diet and physical activity by the attending physician * Cleared for thin liquids and regular textures by physician * Capable of providing informed consent * Able to speak and read English * Owns a smartphone OR is willing to use a study-provided iPhone * Has sufficient cognitive and physical function to use a mobile app * Willing to participate in all study procedures and available for the 12-week duration Exclusion Criteria: * Severe dysphagia that prevents oral intake * Type 1 diabetes * Cognitive impairment (e.g., dementia, post-stroke confusion) that precludes consent or compliance, as judged by the clinical care team * Current participation in another interventional clinical trial * Pregnant or breastfeeding, or planning to become pregnant during the study period * Unwilling or unable to provide written informed consent * Serious comorbid conditions that, in the opinion of the

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Conditions

The condition(s) this trial relates to.

diabetes mellitus prediabetes syndrome stroke disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prediabetes Stroke recurrence Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Hawaii Cancer Center

    RECRUITING

    Honolulu, Hawaii, 96813, United States

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