Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-01 @ 2:13 AM
Study NCT ID:
NCT07120334
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Dietary Intervention for Stroke Survivors With Prediabetes or Type 2 Diabetes
Sponsor:
University of Hawaii
Organization:
Study Overview
Official Title:
mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: