Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
All Genders
NCT07120334

Mobile Health 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

47 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 65Years
All Genders

Eligibility Criteria

Eligible

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 approved by attending physician for oral diet and physical activity
  • Cleared by physician for thin liquids and regular food textures
  • Able to give 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 12 weeks
Not Eligible

You will not qualify if you...

  • Severe swallowing problems that prevent oral intake
  • Type 1 diabetes
  • Cognitive impairment such as dementia or confusion after stroke that prevents consent or compliance
  • Currently taking part in another interventional clinical trial
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Unwilling or unable to provide written informed consent
  • Serious other medical conditions as judged by the clinical care team

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Hawaii Cancer Center

Honolulu, Hawaii, United States, 96813

Actively Recruiting

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Research Team

C

Chloe P Lozano, PhD, MS, GradDip Dietetics

CONTACT

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