PortionSize Ed mobile program to support healthier eating after a recent stroke for people with prediabetes or type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled pilot will enroll 40 adults with a recent stroke and confirmed prediabetes or type 2 diabetes from Queen's Medical Center and randomize them to the PortionSize Ed intervention or standard care. The intervention includes a mobile app with portion-size education, weekly reminders, educational videos, brief weekly food logs, and three counseling sessions with a registered dietitian over 12 weeks. Researchers will collect usability and engagement data and measure changes in diet adherence as well as cardiometabolic outcomes (HbA1c, lipids, blood pressure) and body composition at baseline and 12 weeks. Visits include in-person baseline and 12-week assessments (DXA, BIA, 3D optical scan, fingerstick labs) and a virtual 6-week follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Hawaii Cancer Center
  Honolulu, Hawaii, United States Recruiting

Study contacts

• Study coordinator: Chloe P Lozano, PhD, MS, GradDip Dietetics
• Email: cpanizza@hawaii.edu
• Phone: (808) 586-3010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.