RecruitingPHASE3INTERVENTIONAL

Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes

This research study, called a clinical trial, is investigating if giving people vouchers for healthy food can help lower their blood sugar levels. It's specifically for individuals on a low income who have type 2 diabetes or are at risk of developing it (prediabetes). The main aim is to see if having easier access to nutritious food can significantly improve how well blood sugar is controlled. This is important because good blood sugar control can help prevent health problems linked to diabetes. If successful, this study could show a new way to support people's health.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Unity Health Toronto

Enrolment target

390

Start

21 Mar 2023

Estimated completion

01 Apr 2027

Diabete Type 2

What is this study about?

This study is looking into a simple, but potentially very helpful, idea: Can healthy food vouchers improve blood sugar control for people with type 2 diabetes or prediabetes? Type 2 diabetes is a common condition where the body doesn't use insulin properly, leading to high blood sugar. Prediabetes means your blood sugar levels are higher than normal, but not yet high enough to be called type 2 diabetes. Managing blood sugar is key to staying healthy and avoiding long-term health problems.

The researchers want to see if providing vouchers specifically for healthy foods can make a real difference, especially for people who might find it hard to afford nutritious options. This study is a 'randomised controlled trial', which means some people will receive the vouchers, and others might not, or they might receive a different type of support. This helps the researchers compare the results fairly and understand if the vouchers are truly making a positive impact.

Ultimately, if this study shows that healthy food vouchers can effectively lower blood sugar, it could lead to new ways of supporting people with diabetes and prediabetes, especially those on a lower income. This could be a positive step towards helping more people manage their condition better and live healthier lives.

Key takeaways

This study explores if healthy food vouchers improve blood sugar.
It's for people with type 2 diabetes or prediabetes on a low income.
The study aims to improve health through better food choices.
You might receive healthy food vouchers if you take part.
Regular blood sugar checks will be part of the study.

Who may be eligible?

To join this study, your doctor would need to confirm that your blood sugar levels, measured by something called HbA1c, are between 6.0% and 11.0%. This test gives an average of your blood sugar over the past two to three months. You also need to be someone who finds it difficult to afford enough food or has financial worries.

There are some reasons why you might not be able to join. For example, if someone you live with is already in the study, you wouldn't be able to participate. Also, if you have a very serious illness that means you're not expected to live more than six months, or if you have severe allergies to many common foods, you wouldn't be suitable.

Other reasons not to be included are if you need all your nutrition through a tube or injections, or if you have a blood condition that would make the HbA1c test results hard to understand. And, if your HbA1c is higher than 11.0%, you wouldn't be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have type 2 diabetes or high blood sugar (prediabetes)?
Is your average blood sugar (HbA1c) between 6.0% and 11.0%?
Do you face difficulties affording enough food or have financial worries?
Do you not live with another study participant?
Are you generally in good health and not facing a very short life expectancy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive vouchers to buy healthy foods. The study is designed to compare different groups, so some people might get the vouchers and others might not, or they might receive something different. Researchers will regularly check your blood sugar levels and likely ask questions about your diet and general wellbeing. The study will involve a number of visits to a clinic or research centre for checks and assessments over a period of time. You won't be given any new medication as part of this study related to your diabetes; it's focused on the food vouchers. The total length of your involvement in the study will be explained to you before you agree to participate.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the healthy food vouchers help improve your blood sugar control, which could lead to better overall health. There are generally low risks associated with simply receiving food vouchers and having your blood sugar checked, but any procedure, including blood tests, carries very small risks like mild discomfort or bruising. We will make sure you fully understand what's involved before you agree to take part. Remember, joining a study is always your choice, and you are free to withdraw at any time without giving a reason, and it won't affect your usual medical care.

Locations (1)

St Michael's Hospital Academic Family Health Team
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is type 2 diabetes?

Type 2 diabetes is a condition where your body doesn't use insulin properly, leading to high blood sugar levels.

What is prediabetes?

Prediabetes means your blood sugar levels are higher than normal but not yet high enough for a diabetes diagnosis.

What are 'healthy food vouchers'?

These are vouchers that can be used to buy nutritious foods, supporting a balanced diet.

Will I have to pay to join the study?

No, you will not have to pay anything to participate in this research study.

What is an HbA1c test?

An HbA1c test is a blood test that shows your average blood sugar levels over the past 2-3 months.

How to find out more

Nav Persaud

nav.persaud@utoronto.ca 416-864-6060 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.