Stroke RecurrenceNCT07120334
Mobile Health Dietary Intervention for Stroke Survivors With Prediabetes or Type 2 Diabetes
A study testing PortionSize Ed + MedDiet Support in people with Stroke Recurrence and Type 2 Diabetes, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stroke Recurrence, Type 2 Diabetes, Prediabetes
- What is being tested?
- PortionSize Ed + MedDiet Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Chloe P Lozano, PhD, MS, GradDip Dietetics, 8086400339, cpanizza@hawaii.edu
About this study
Official title: mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D
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:
Read more
- 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.
Read the 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
- Conditions
- Stroke Recurrence, Type 2 Diabetes, Prediabetes
- Being tested
- PortionSize Ed + MedDiet Support, Standard of care for Stroke and Prediabetes or T2D
- Keywords
- PortionSize Ed, Stroke, Diabetes, Prediabetes, Type 2 Diabetes, T2D, Mediterranean Diet, mHealth, Hawaii
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Stroke, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PortionSize Ed + MedDiet SupportBehavioural
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 for Stroke and Prediabetes or T2DBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PortionSize Ed + MedDiet Support |
| 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. Receives: Behavioral: Standard of care for Stroke and Prediabetes or T2D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 11 months
Secondary outcomes (8)
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.
Measured: 11 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 12 weeks
Change in Body Fat Percentage Measured by BIA
Body fat percentage measured by bioelectrical impedance analysis (BIA)
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120334
- Sponsor's protocol ID
- RA-2025-302
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D
- ClinicalTrials.gov ID
- NCT07120334
- Acronym / sponsor ID
- RA-2025-302
- Conditions
- Stroke Recurrence, Type 2 Diabetes, Prediabetes
- Keywords
- PortionSize Ed, Stroke, Diabetes, Prediabetes, Type 2 Diabetes, T2D, Mediterranean Diet, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Queen's Medical Center
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PortionSize Ed + MedDiet Support | Experimental | Behavioral: PortionSize Ed + MedDiet SupportFull 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 | Behavioral: Standard of care for Stroke and Prediabetes or T2DUses a basic version of the app without feedback or RDN support and receives usual care for stroke recovery for 12 weeks. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PortionSize Ed + MedDiet SupportFull 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. | Behavioural | PortionSize Ed + MedDiet Support |
| Standard of care for Stroke and Prediabetes or T2DUses 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. | Behavioural | Standard of Care |
Primary outcome
Participant Acceptability of PortionSize Ed App
Time frame: 11 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 Rate
Time frame: 11 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 Features
Time frame: 11 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 App
Time frame: 11 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PortionSize Ed + MedDiet Support in people with Stroke Recurrence and Type 2 Diabetes, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloe P Lozano, PhD, MS, GradDip Dietetics ((808) 586-3010, cpanizza@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Acceptability of PortionSize Ed App (time frame: 11 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.