NCT07120334

Mobile Health Dietary Intervention for Stroke Survivors With Prediabetes or Type 2 Diabetes

Recruiting now NA Last updated 21 January 2026

What this trial tests

NA trial testing PortionSize Ed + MedDiet Support in Stroke Recurrence in 40 participants. Currently enrolling.

Timeline

1 February 2026

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	University of Hawaii
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	40
Start date	1 February 2026
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• PortionSize Ed + MedDiet Support
• Standard of care for Stroke and Prediabetes or T2D

Conditions studied

• Stroke Recurrence — all drugs for Stroke Recurrence →
• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• Prediabetes — all drugs for Prediabetes →

Sponsor

University of Hawaii

Who can join

Adults 30 to 65, any sex, with Stroke Recurrence or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives: This study aims to test whether a mobile app called PortionSize Ed can help adults who have had a recent stroke and also have prediabetes or type 2 diabetes improve their diet. Specifically, we want to see if the app can help people follow a Mediterranean-style diet, which may lower the risk of future strokes and improve overall health.

The main goals are to:

* Test if the app is easy to use and acceptable to participants.
* See whether the app helps people follow a healthier diet.
* Look at changes in health indicators like blood sugar, cholesterol, blood pressure, and body fat.

Design and Outcome:

This is a randomized controlled pilot study that will involve 40 participants. All participants will be recruited from Queen's Medical Center after a recent stroke and will be randomly assigned to one of two groups:

Intervention Group: Uses the full PortionSize Ed app, gets weekly reminders and educational videos, and has 3 sessions with a registered dietitian (RDN) over 12 weeks.

Control Group: Uses a basic version of the app without feedback or RDN support, and receives usual care for stroke recovery.

All participants will continue to receive standard care from Queen's, including the My Stroke Recovery Guide. The study lasts 12 weeks, with visits at the beginning and end to collect health data and feedback on the app.

Schedule and Type of Evaluations/Interventions:

Participants will complete the following:

Baseline and Week 12 Visits: In-person assessments for blood sugar (HbA1c), cholesterol, blood pressure, height, weight, and body composition (using DXA, BIA, and 3D imaging), as well as surveys about their diet and activity levels.

Intervention Group Only:

* Three virtual counseling sessions with a registered dietitian (Week 1, 6, 12)
* Weekly nutrition goal tracking and texting with the dietitian
* Watching short educational videos through the app
* Receiving app-based feedback on how well their diet follows Mediterranean Diet recommendations

Duration of Study: The study will last 12 weeks for each participant, with an optional long-term follow-up using medical records.

Sample Size and Population: The study will include 40 adults, ages 30 to 65, who:

* Recently experienced a stroke
* Have a history of prediabetes or type 2 diabetes
* Are medically stable and able to use a smartphone (or willing to use a study-provided iPhone)
* People will be excluded if they have severe swallowing issues, cognitive problems, or dietary needs that would make it hard to follow a Mediterranean-style diet.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.