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

This study is testing if a mobile app called PortionSize Ed can help adults who recently had a stroke and also have prediabetes or type 2 diabetes. The goal is to see if using the app, along with personalized dietary feedback and dietitian support, helps people follow a Mediterranean-style diet. This could potentially lower the risk of future strokes and improve overall health. You might be able to join if you are 30-65 years old, recently had a stroke, and have prediabetes or type 2 diabetes (diagnosed by HbA1c levels). The study will be successful if the app is easy to use and helps people eat healthier. The current status of this study is unclear.

Study design
This is a randomized controlled pilot study involving 40 participants. It compares a group using the full PortionSize Ed app with dietitian support to a group using a basic version of the app with standard care.
What's involved
You would have a baseline visit, a virtual visit at week 6, and a final visit at week 12. These visits include blood tests, body measurements, questionnaires, and app training.
Compensation
You will receive a study stipend of $50 at the baseline visit and $60 at the week 6 visit.
Follow-up
The primary endpoints, such as app acceptability and participant satisfaction, are measured at 11 months after the study begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07120334

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

Recruiting
NAAges 30–65InterventionalPrevention
University of Hawaii
~40 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:PortionSize Ed + MedDiet SupportStandard of care for Stroke and Prediabetes or T2D

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participant Acceptability of PortionSize Ed App
Measured over 11 months
+3 more outcomes measured
Stroke Recurrence
Type 2 Diabetes
Prediabetes
1 sites across 1 states
Hawaii1
Chloe P Lozano, PhD, MS, GradDip Dietetics
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Eligibility criteria

Inclusion

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

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
  • Participant Acceptability of PortionSize Ed App11 months

    Mean acceptability score measured by the Computer System Usability Questionnaire (CSUQ), a validated 19-item Likert scale instrument assessing system usefulness, information quality, and interface quality. Each item is scored on a 7-point scale ranging from 1 (Strongly Agree) to 7 (Strongly Disagree). Unit of Measure: Mean CSUQ score (1-7) Direction of Scoring: Lower scores indicate higher acceptability and better usability.

  • Participant Retention Rate11 months

    Percentage of participants who complete all scheduled study assessments (Weeks 1, 6, 12). Higher percentages indicate better retention and feasibility of the intervention.

  • Participant Satisfaction with Study Procedures and App Features11 months

    Description: Mean satisfaction score measured using the PortionSize Ed User Satisfaction Survey (USS), a 10-item Likert-style instrument that evaluates ease of use and satisfaction with app components including photo features, videos, and feedback. Items are scored on a scale of 1 to 5. The USS also includes open-ended questions for qualitative feedback. Units of Measure: Score on a 1-5 Likert scale (higher scores indicate greater satisfaction) Direction of Scoring: Higher scores indicate greater satisfaction and ease of use.

  • Participant Engagement with the PortionSize Ed App11 months

    Mean number of app logins and food photo entries submitted by participants over the 12-week intervention period. Engagement will be assessed using backend app usage data, with higher counts indicating greater engagement.