PortionSize Ed mobile program to support healthier eating after a recent stroke for people with prediabetes or type 2 diabetes
mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D
See if a mobile app called PortionSize Ed helps adults who recently had a stroke and have prediabetes or type 2 diabetes follow a Mediterranean-style diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | University of Hawaii Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT07120334 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 30 to 65 who had an ischemic, hemorrhagic, or transient ischemic attack within 1–14 days, have confirmed prediabetes or type 2 diabetes, are medically stable, English-speaking, and able to use a smartphone or a study-provided iPhone are ideal candidates.
Not a fit: Patients with severe dysphagia that prevents oral intake, type 1 diabetes, significant cognitive impairment preventing consent or app use, inability to attend study visits, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the app could help participants improve diet quality and cardiometabolic markers, which may lower the risk of future strokes.
How similar studies have performed: Prior research shows Mediterranean diets and some mobile health nutrition programs can improve cardiometabolic risk factors, but using a portion-size app with dietitian support in the early post-stroke period is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Honolulu, Hawaii
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.