RecruitingNot ApplicableNCT07120334

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

mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D


Sponsor

University of Hawaii

Enrollment

40 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mobile health dietary app to help stroke survivors who also have prediabetes or type 2 diabetes improve their diet and manage blood sugar. Strokes and diabetes are closely linked, and this study aims to see if a smartphone-based nutrition program can make a real difference in recovery and metabolic health. **You may be eligible if...** - You are aged 30–65 and had a stroke (ischemic, hemorrhagic, or TIA) within the past 1–14 days - You have a confirmed diagnosis of prediabetes or type 2 diabetes (based on HbA1c) - You are medically stable and cleared for a normal diet and light physical activity - You can speak and read English - You own a smartphone or are willing to use one provided by the study **You may NOT be eligible if...** - Your stroke happened more than 14 days ago - You cannot eat or swallow normally - You do not have (or are unwilling to use) a smartphone - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPortionSize Ed + MedDiet Support

Full PortionSize Ed app access with personalized dietary feedback, educational videos, 3 virtual sessions with a registered dietitian (RDN), standard of care (for post-stroke with pre-diabetes or T2D) over 12 weeks.

BEHAVIORALStandard of care for Stroke and Prediabetes or T2D

Uses a basic version of the PortionSize Ed app without feedback or RDN support and receives usual care for stroke recovery and prediabetes or T2D for 12 weeks.


Locations(1)

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

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NCT07120334


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