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

Recruiting now · Not applicable

Conditions studied: Stroke Recurrence, Type 2 Diabetes, Prediabetes

In brief

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.

Key facts

Study ID: NCT07120334
Run by: University of Hawaii
People needed: 40
Starts: 2026-02-01
Expected to finish: 2026-12-31
Last updated by the study team: 2026-01-21

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Hawaii Cancer Center — Honolulu, Hawaii, United States (enrolling)

Full record on ClinicalTrials.gov

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