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

Study Summary

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 recommendation

Primary Outcome

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.

Conditions Studied

Interventions

• BEHAVIORAL PortionSize Ed + MedDiet Support
• BEHAVIORAL Standard of care for Stroke and Prediabetes or T2D

Study Locations (1)