40 Participants Needed

Mobile Health Dietary Intervention for Stroke and Diabetes

CP
Overseen ByChloe P Lozano, PhD, MS, GradDip Dietetics
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Hawaii
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app called PortionSize Ed to determine if it can help individuals who have recently experienced a stroke and have prediabetes or type 2 diabetes improve their diet. The app promotes a Mediterranean-style diet, which might reduce the risk of future strokes and enhance overall health. Participants will either receive full app access with dietitian support or use a basic version of the app. This trial suits those who have recently had a stroke, have prediabetes or type 2 diabetes, and are comfortable using a smartphone. As an unphased trial, it offers a unique opportunity to explore innovative dietary support through technology.

What prior data suggests that this mobile health dietary intervention is safe for stroke and diabetes patients?

Research has shown that following a Mediterranean diet can lower the risk of stroke and help manage diabetes. This diet includes plenty of fruits, vegetables, nuts, and healthy fats like olive oil. Studies indicate it can improve heart health and control blood sugar levels, benefiting people with diabetes or those who have had a stroke.

Regarding the PortionSize Ed app, specific safety data is not yet available. The study is in an early stage, so information about its safety is limited. However, as a diet guidance app, it is considered low-risk. Participants will also continue to receive standard stroke care, adding an extra layer of safety.

Overall, using the app to focus on a healthy diet appears safe and could help manage health after a stroke and with diabetes.12345

Why are researchers excited about this trial?

Researchers are excited about the PortionSize Ed + MedDiet Support treatment because it offers a personalized and interactive approach to managing stroke recovery and diabetes. Unlike standard care, which typically involves basic app usage without feedback, this treatment provides tailored dietary feedback, educational videos, and virtual sessions with a dietitian. This comprehensive support could enhance patient engagement and adherence to dietary recommendations, potentially leading to better health outcomes.

What evidence suggests that the PortionSize Ed app is effective for improving diet in stroke patients with diabetes?

Studies have shown that following a Mediterranean diet can improve health for people with conditions like diabetes and stroke. Research indicates that this diet links to lower risks of heart disease and better control of blood sugar levels. Previous participants found it easier to maintain healthier eating habits, which is crucial for recovery and long-term health. In this trial, participants in the PortionSize Ed + MedDiet Support arm will use the PortionSize Ed app. This app helps people follow a Mediterranean-style diet by providing personalized feedback and support. Overall, this combination of diet and digital support could improve health measures like blood sugar, cholesterol, and blood pressure.13467

Are You a Good Fit for This Trial?

This trial is for adults aged 30-65 who've had a stroke recently and also have prediabetes or type 2 diabetes. They must be medically stable, able to eat and drink normally, use a smartphone, and commit to the study's 12-week duration. People with severe swallowing issues, cognitive impairments, or special dietary needs that conflict with a Mediterranean diet can't join.

Inclusion Criteria

I can understand and agree to the study's details.
I either own a smartphone or am willing to use one provided by the study.
I can use a smartphone app without help.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial in-person assessments including blood tests, body composition measurements, and questionnaires

1 day
1 visit (in-person)

Intervention

Participants use the PortionSize Ed app with varying levels of support, including virtual dietitian sessions for the intervention group

12 weeks
3 visits (virtual for intervention group), ongoing app engagement

Follow-up

Final in-person assessments to measure changes in health indicators and collect feedback on the app

1 day
1 visit (in-person)

Optional Long-term Follow-up

Participants may be monitored using medical records for long-term outcomes

What Are the Treatments Tested in This Trial?

Interventions

  • PortionSize Ed + MedDiet Support

Trial Overview

The trial tests if an app called PortionSize Ed helps stroke survivors with prediabetes or type 2 diabetes follow a Mediterranean-style diet. It compares two groups: one using the app with dietitian support and another receiving standard care. Health indicators like blood sugar and cholesterol are measured before and after the intervention.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PortionSize Ed + MedDiet SupportExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials
122
Recruited
55,200+

Queen's Medical Center

Collaborator

Trials
24
Recruited
4,900+

Citations

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