Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes (NCT07598266) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes
Vietnam253 participantsStarted 2026-06-01
Plain-language summary
The purpose of this study is to find out if learning about healthy eating can help people with diabetes control their blood sugar better.
This study is for men and women between 16 and 70 years old who currently use only oral-diabetic medications or in combination with basal insulin but their glycemia have not been in the target range.
The investigators want to answer the following questions:
Can nutrition education help lower HbA1c (a blood test that shows average blood sugar over the past 3 months)? Can it improve nutrition related knowledge, attitude and behaviors among patients with type 2 diabetes? Will it help reduce fasting blood sugar, lipid levels, body weight, and the number of times low blood sugar (hypoglycemia) happens?
Participants will be divided into two groups:
One group will receive a nutrition booklet. The other group will receive the same booklet and join four monthly lessons with a researcher.
The four lessons will talk about:
Goals for managing diabetes Main nutrients in food and their effects on glycemia How to plan meals How to eat in a way that supports better blood sugar control
Who can participate
Age range
15 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* People between 16 and 70 years old.
* People who come to Cho Ray Hospital for diabetes care and plan to keep getting care there for at least six months.
* People who have diabetes and have been prescribed diabetes medicine.
* People who were recently diagnosed with diabetes, based on the latest guidelines from the American Diabetes Association.
* People whose blood sugar (HbA1c) level is higher than 7.5 %.
* People who are currently using only oral anti-diabetic medications or in combination with basal insulin
Exclusion Criteria:
* People who are seriously ill and need to stay in the hospital, such as those with infections, pneumonia, heart attacks, strokes, or infected diabetic foot.
* People who have cancer, serious mental health problems, or problems with drug use.
* People who do not want to take part or cannot follow the study plan.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves a structured nutrition education program for type 2 diabetes — how does that kind of program compare to the nutrition guidance I'm already getting from my care team, and would joining a study like this add anything meaningful for my situation?
2The trial hasn't started recruiting yet — given where I am in managing my diabetes right now, does it make sense to wait for this study to open, or should we focus on other options in the meantime?
3The main thing this study is measuring is change in HbA1c over 6 months — based on my current HbA1c, do you think a nutrition education program alone is likely to move that number enough, or would I need medication changes alongside it?
4Since this is a Phase N/A study focused on an educational intervention rather than a drug, what do we actually know about the risks of participating, and is there a chance I'd be assigned to a control group that doesn't receive the full program?
5Are there established nutrition education programs or diabetes self-management classes already available to me outside of a clinical trial that might give me similar benefits without having to wait for this study to begin?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control