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

Official title

mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D

Overview

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 recommendations 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: * Recently experienced a stroke * Have a history of prediabetes or type 2 diabetes * Are medically stable and able to use a smartphone (or willing to use a study-provided iPhone) * People will be excluded if they have severe swallowing issues, cognitive problems, or dietary needs that would make it hard to follow a Mediterranean-style diet.

Detailed description

Study Visits:

Baseline Visit (Week 0) at UHCC - All Participants:

* Consent form signed and randomization to a study group * Fingerstick blood test to measure HbA1c and lipid levels * Height, weight, blood pressure, and body composition measurements using DXA, BIA, and 3D Optical Scan * Questionnaires: Demographics, physical activity (IPAQ-SF), Mediterranean Diet adherence (MEDAS), and current medications * PortionSize Ed app training and 3-day food logging using the app * Pregnancy test (urine) for participants of childbearing potential * Counseling with the registered dietitian (\~30-60 minutes) (Intervention only) * Receive study stipend ($50)

Week 6 Visit, Virtual Visit:

* Follow-up questionnaires and review of app engagement (Intervention only) * Counseling with the registered dietitian (\~30-60 minutes) (Intervention only) * Review of medications and dietary services received * Self-reported adherence and barriers to diet change (Intervention only) * Receive study stipend ($60)

Week 12 Visit at UHCC - All Participants:

* Repeat body composition measurements (DXA, BIA, 3DO) * Repeat fingerstick blood tests (HbA1c and lipids) * Final questionnaires and MEDAS * Final 3-day food record * Satisfaction and usability surveys * Counseling with the registered dietitian (\~30-60 minutes) (Intervention only) * Return study iPhone (if applicable) * Receive study stipend ($90)

Between visits for intervention group only:

* Log one day food intake per week (\~10-15 minutes) * Text weekly dietary goal (\~5 minutes) * Watch a short nutrition video each week (\~3 minutes) * Weekly reminders to complete a 1-day food log/week between study visits

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

Interventions

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

Primary outcome measures

• Participant Acceptability of PortionSize Ed App [Time frame: 11 months]
• Participant Retention Rate [Time frame: 11 months]
• Participant Satisfaction with Study Procedures and App Features [Time frame: 11 months]
• Participant Engagement with the PortionSize Ed App [Time frame: 11 months]

Secondary outcome measures (8)

• Mediterranean Diet Adherence Score (MEDAS-14) [Time frame: 11 months]
• App-Based Proportion-of-Goal Mediterranean Diet Adherence Score [Time frame: 11 months]
• Change in Hemoglobin A1c (HbA1c) from Baseline to Week 12 [Time frame: 11 months]
• Change in Lipid Profile from Baseline to Week 12 [Time frame: 11 months]
• Change in Systolic and Diastolic Blood Pressure from Baseline to Week 12 [Time frame: 11 months]
• Change in Body Composition Measured by DXA [Time frame: Baseline and 12 weeks]
• Change in Body Fat Percentage Measured by BIA [Time frame: Baseline and 12 weeks]
• Change in Body Circumference and Volume by 3D Optical Scan [Time frame: Baseline and 12 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Hawaii Cancer Center — Honolulu

Identifiers

NCT: NCT07120334 · RA-2025-302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗