ClinConnect ClinConnect Logo
Search / Trial NCT07120334

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

Launched by UNIVERSITY OF HAWAII · Aug 6, 2025

Trial Information

Current as of September 06, 2025

Not yet recruiting

Keywords

Portion Size Ed Stroke Diabetes Prediabetes Type 2 Diabetes T2 D Mediterranean Diet M Health Hawaii

ClinConnect Summary

This clinical trial is studying whether a mobile phone app called PortionSize Ed can help people who have recently had a stroke and also have prediabetes or type 2 diabetes improve their eating habits. The app focuses on encouraging a Mediterranean-style diet, which is known to be heart-healthy and may reduce the chance of having another stroke. The study wants to see if the app is easy to use, if it helps people eat healthier, and if it can improve important health measures like blood sugar, cholesterol, blood pressure, and body fat.

Adults aged 30 to 65 who have had a stroke within the past two weeks and have prediabetes or type 2 diabetes may be eligible to join. Participants must be medically stable, able to eat regular foods, and comfortable using a smartphone (a phone can be provided if needed). The study lasts 12 weeks, during which half the participants will use the full app with extra support like weekly reminders, educational videos, and virtual meetings with a dietitian. The other half will use a simpler version of the app without those extras. Everyone will continue their regular stroke care. Health checks and surveys will be done at the start and end of the study to see how well the app works. This trial aims to find new ways to support stroke survivors in managing their health through better diet.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 30 to 65 years
  • Recent stroke (ischemic or hemorrhagic), 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

About University Of Hawaii

The University of Hawaii is a leading research institution committed to advancing medical science and improving health outcomes through innovative clinical trials. With a diverse team of experienced researchers and access to a wide range of resources, the university fosters collaborative initiatives that aim to address pressing health challenges. By integrating cutting-edge technology and multidisciplinary expertise, the University of Hawaii conducts rigorous clinical research to enhance understanding of various medical conditions, ultimately contributing to the development of effective therapies and interventions for diverse populations.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported