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

mHealth Dietary Intervention for Stroke Survivors With Prediabetes or T2D

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 12 visits
  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 12-week study tests whether the PortionSize Ed phone app helps people eat a healthier, Mediterranean-style diet. It is for adults ages 30 to 65 who recently had a stroke or mini-stroke and have prediabetes or type 2 diabetes. The study also checks how easy the app is to use and looks at changes in health.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 30 to 65 years old.
  • Had a stroke from a blocked blood vessel or bleeding, or a TIA (mini-stroke), 1 to 14 days before joining.
  • Have prediabetes or type 2 diabetes confirmed by an HbA1c blood test, which measures blood sugar over time.
  • Have stable health and a doctor's approval to eat regular foods, drink thin liquids, and be physically active.
  • Can understand the study and agree to take part.
  • Can speak and read English.
  • Own a smartphone or will use a study-provided iPhone, and have the thinking and physical skills to use an app.
  • Will take part in all study tasks and be available for 12 weeks.

Who can't join

  • Have severe trouble swallowing that prevents eating or drinking by mouth.
  • Have type 1 diabetes.
  • Have memory or thinking problems that the care team believes prevent agreeing to or following the study.
  • Are taking part in another trial that tests a treatment or health program.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Cannot or will not give written agreement to take part.
  • Have diet needs that make it hard to follow a Mediterranean-style diet.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

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