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| Name | Class |
|---|---|
| Queen's Medical Center | OTHER |
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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:
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:
Duration of Study: The study will last 12 weeks for each participant, with an optional long-term follow-up using medical records.
Sample Size and Population: The study will include 40 adults, ages 30 to 65, who:
Study Visits:
Baseline Visit (Week 0) at UHCC - All Participants:
Week 6 Visit, Virtual Visit:
Week 12 Visit at UHCC - All Participants:
Between visits for intervention group only:
Between visits for Active Comparator Group:
• Basic version of the app (no real-time feedback or counseling) and continue usual care, including the My Stroke Recovery Guide.
Length of Time in this Study:
Participation in this study will last approximately 12 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PortionSize Ed + MedDiet Support | Experimental | Full PortionSize Ed app access with personalized dietary feedback, educational videos, 3 virtual sessions with a registered dietitian (RDN), standard of care (for post-stroke with pre-diabetes or T2D) over 12 weeks. |
|
| Standard of Care | Active Comparator | Uses a basic version of the app without feedback or RDN support and receives usual care for stroke recovery for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PortionSize Ed + MedDiet Support | Behavioral | Full PortionSize Ed app access with personalized dietary feedback, educational videos, 3 virtual sessions with a registered dietitian (RDN), standard of care (for post-stroke with pre-diabetes or T2D) over 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Acceptability of PortionSize Ed App | 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. | 11 months |
| Participant Retention Rate | Percentage of participants who complete all scheduled study assessments (Weeks 1, 6, 12). Higher percentages indicate better retention and feasibility of the intervention. | 11 months |
| Participant Satisfaction with Study Procedures and App Features | 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. | 11 months |
| Participant Engagement with the PortionSize Ed App | 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. | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mediterranean Diet Adherence Score (MEDAS-14) | Mean change in dietary adherence to the Mediterranean Diet, assessed using the 14-item Mediterranean Diet Adherence Screener (MEDAS-14), a validated questionnaire with scores ranging from 0 to 14. Higher scores indicate better adherence to the Mediterranean Diet. | 11 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chloe P Lozano, PhD, MS, GradDip Dietetics | Contact | (808) 586-3010 | cpanizza@hawaii.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii Cancer Center | Recruiting | Honolulu | Hawaii | 96813 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D020521 | Stroke |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care for Stroke and Prediabetes or T2D | Behavioral | Uses a basic version of the PortionSize Ed app without feedback or RDN support and receives usual care for stroke recovery and prediabetes or T2D for 12 weeks. |
|
| App-Based Proportion-of-Goal Mediterranean Diet Adherence Score |
Mean proportion of Mediterranean Diet food group goals met over the study period, calculated from PortionSize Ed app data. For each tracked food group, participants receive a score from 0 to 1 based on the ratio of actual intake to the goal intake (capped at 1.0). The average across all food groups yields a final adherence score from 0 to 1, with higher values indicating closer adherence to dietary goals. |
| 11 months |
| Change in Hemoglobin A1c (HbA1c) from Baseline to Week 12 | HbA1c will be assessed through a venous blood draw analyzed in a certified clinical laboratory. | 11 months |
| Change in Lipid Profile from Baseline to Week 12 | Lipid panel including total cholesterol, HDL-C, LDL-C, and triglycerides will be assessed using venous blood samples analyzed in a certified clinical laboratory. | 11 months |
| Change in Systolic and Diastolic Blood Pressure from Baseline to Week 12 | Blood pressure will be measured using a calibrated automated monitor after participants are seated quietly for at least 5 minutes. Two readings will be averaged. | 11 months |
| Change in Body Composition Measured by DXA | Total fat mass (kg), fat mass percentage (%), and fat mass index (kg/m²) measured via dual-energy X-ray absorptiometry (DXA). | Baseline and 12 weeks |
| Change in Body Fat Percentage Measured by BIA | Body fat percentage measured by bioelectrical impedance analysis (BIA) | Baseline and 12 weeks |
| Change in Body Circumference and Volume by 3D Optical Scan | Measurements include waist circumference and total body volume assessed using a 3D optical scanner. | Baseline and 12 weeks |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |