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.
Mobile Health Dietary Intervention for Stroke Survivors With Prediabetes or Type 2 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.