Actively Recruiting
mHealth Dietary Intervention for Stroke Survivors With Prediabetes or Type 2 Diabetes
Led by University of Hawaii · Updated on 2026-01-21
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Hawaii
Lead Sponsor
Q
Queen's Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a mobile app called PortionSize Ed to help adults who recently had a stroke and have prediabetes or type 2 diabetes improve their diet. The study aims to test whether the app is easy to use and helps participants follow a Mediterranean-style diet, which may reduce the risk of future strokes and improve overall health. This randomized controlled pilot study will include 40 adults aged 30 to 65 who are medically stable and able to use a smartphone. Participants are randomly assigned to one of two groups for 12 weeks. The intervention group uses the full PortionSize Ed app with personalized dietary feedback, weekly reminders, educational videos, and three virtual counseling sessions with a registered dietitian. The control group uses a basic version of the app without feedback or dietitian support and continues with usual stroke recovery care. All participants receive standard care from Queen's Medical Center and complete visits at the start and end of the study. Throughout the study, participants attend baseline and week 12 in-person visits for blood sugar, cholesterol, blood pressure, body composition measurements, and questionnaires on diet and activity. The intervention group also logs weekly food intake, texts dietary goals, watches nutrition videos, and has counseling sessions. Researchers will measure app acceptability, participant retention, satisfaction, diet adherence, and changes in health indicators such as HbA1c, lipids, blood pressure, and body composition. The total participation lasts about 12 weeks with an optional long-term follow-up using medical records.
CONDITIONS
Brief Title
Mobile Health Dietary Intervention for Stroke Survivors With Prediabetes or Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 30 to 65 years
- Recent stroke (ischemic, hemorrhagic, or transient ischemic attack) within 1 to 14 days before enrollment
- Confirmed diagnosis of prediabetes or type 2 diabetes based on HbA1c results
- Medically stable and cleared for oral diet and physical activity by a physician
- Cleared for thin liquids and regular food textures by a physician
- Able to provide informed consent
- Able to speak and read English
- Owns a smartphone or 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 study duration
You will not qualify if you...
- Severe swallowing difficulty that prevents oral intake
- Diagnosis of type 1 diabetes
- Cognitive impairment that prevents consent or compliance, as judged by clinical care team
- Currently participating in another interventional clinical trial
- Pregnant, breastfeeding, or planning pregnancy during the study period
- Unwilling or unable to provide written informed consent
- Serious other medical conditions as judged by the study team
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and baseline assessments
Duration - Approximately 12 weeks
Participants receive dietary intervention through app usage and counseling sessions with a registered dietitian if assigned to the intervention group, or basic app access and usual care if assigned to the comparator group.
1 baseline visit, 1 virtual follow-up visit at Week 6, and 1 in-person visit at Week 12
Trial Site Locations
Total: 1 location
1
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Actively Recruiting
Research Team
C
Chloe P Lozano, PhD, MS, GradDip Dietetics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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