An interventional study of Nutrition educational program in Diabetes Mellitus, sponsored by Cho Ray Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Cho Ray Hospital · Not applicable, Interventional, and Treatment
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 18 and 70 years old who use insulin at least twice a day but still have high blood sugar.
We 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 knowledge about nutrition, quality of life, and make blood sugar more stable? 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 How to plan meals How to eat in a way that supports better blood sugar control
This study will involve 115 people with diabetes who need to take insulin at least twice a day. It includes those who already use multiple insulin injections but still have high blood sugar, and those who are newly switched to at least two insulin shots daily because their blood sugar is not well controlled with pills or pills plus one injection.
The study will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, and will run from 2025 to the end of 2026. People will be invited to join at the Endocrinology Consultation Unit. If they agree, their phone number will be collected and the research team will call them later to explain more about the study. If they are still interested, they'll be asked to keep a food diary for three days before their screening.
On the screening day, they'll sign a short consent form, get blood tests to check their sugar, HbA1c, cholesterol, and kidney function, talk with a nutrition researcher about their food diary, and have a usual consultation with their doctor. If they meet all the criteria and agree to take part, they'll sign the full consent form and take short tests on nutrition knowledge and quality of life. The quality of life questionnaire used is the SF-36 questionnaire, and nutrition knowledge is assessed using the Diabetes-related Nutrition Knowledge Questionnaire (DRNK-Q).
After that, they will be randomly assigned to one of two groups. One group will get a nutrition booklet only. The other group will receive the booklet plus attend four monthly sessions with a researcher to learn about healthy eating for diabetes. In each group, 10 participants will also wear a flash glucose monitor (a small device that checks sugar levels without finger pricks) three times: at the beginning, after 3 months, and after 6 months. These participants will be selected based on age, HbA1c level, ability to use the device, and whether they often experience low blood sugar.
During the 6-month study period, all participants will have blood tests every 3 months to check HbA1c, fasting sugar, and lipid; they will be asked monthly about any low blood sugar episodes; they will repeat the nutrition and quality of life tests at 6 months; their weight and waist size will be measured every 3 months, and their height will be measured at the start of the study
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 115 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Cho Ray Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm only receive a nutrition booklet, written and designed by researchers. They don't join the lessons with the researcher.
Intervention group receives the same booklet and attends four monthly lessons with a researcher about healthy eating for diabetes.
Other: Nutrition educational program
Participants in the intervention group will attend a structured nutrition education program consisting of four monthly sessions, each lasting approximately 40 to 60 minutes. These sessions will be conducted in small groups by the researcher. Each session includes: A 20-30 minute presentation delivered by the researcher using visual aids, such as slides and educational images. A 20-30 minute interactive discussion to address participants' questions, clarify concepts. Session Topics: Treatment Goals in Diabetes Care: Overview of blood glucose targets and the importance of achieving glycemic control. Key Nutritional Components of Food: Roles of carbohydrates, proteins, fats, fiber, and their impact on blood glucose. Principles of Meal Planning: Adjusting energy intake based on physical activity levels and BMI. Understanding the Food Exchange System: Introduction to food exchange lists; selecting the appropriate number of food exchanges to meet individual energy needs.
the difference in the change of HbA1c between the two groups after six months of follow-up
We will check each person's HbA1c level before starting the program, and then again every three months. After six months, we will look at how much each person's HbA1c has changed compared to the beginning. Then we'll compare the average change between the two groups using a statistical test.
Time frame: For enrollment to the end of study at 6 months
The changes in quality of life after six months of follow-up within and between groups
Quality of life will be assessed at the start of the study and again after six months using the SF-36 questionnaire. The total scores from the questionnaire will be calculated, and the average change in scores will be compared between the two groups.
Time frame: From enrollment to the end of study at 6 months
The change in nutrition knowlege at the start of the study and after 6 months between two groups
Nutrition knowledge will be assessed using the Diabetes-related Nutrition Knowledge questionnaire (DRNK-Q) at the start of the study and again after six months. The mean change in total score of the questionnaire before and after six months will be compared between the two groups. The maximum score is 27 for the people who consume alcohol, and is 25 for the people who don't consume alcohol. The minimum score is zero. The higher score indicates an improvement in nutritional knowledge.
Time frame: From enrollment to the end of study at 6 months.
The changes in BMI (Body mass index) after six months of follow-up within and between groups
BMI will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in Waist Circumference after six months of follow-up within and between groups
Waist Circumference will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma LDL cholesterol (bad cholesterol) after six months of follow-up within and between groups
Plasma LDL cholesterol (bad cholesterol) will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma total cholesterol after six months of follow-up within and between groups
Plasma total cholesterol will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma triglycerides after six months of follow-up within and between groups
Plasma triglycerides will be measured at the beginning of the study and every three months. Changes in this health indicator over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Time frame: From enrollment to the end of treatment at 6 months
The changes in plasma HDL cholesterol (good cholesterol) after six months of follow-up within and between groups
Plasma HDL cholesterol (good cholesterol) will be measured at the beginning of the study and every three months. Changes in these health indicators over time will be tracked within each group, and the average changes over six months will be compared between the two groups.
Time frame: From enrollment to the end of treatment at 6 months
The change in total daily insulin dose before and after the intervention between groups
The total daily insulin dose will be collected each month. The changes in total daily insulin before and six months after the intervention of the two groups will be compared.
Time frame: From enrollment to the end of study at six months
The change in time in range over six months between groups: standard group and nutrition intervention group
We assess blood glucose fluctuations using a flash continuous glucose monitoring system at the start of the study and then every three months for six months. The mean change in time in range within groups will be assessed and compared across the groups.
Time frame: From enrollment to the end of study at six months
The change in the number of insulin injections per day before and after the intervention between groups
The number of insulin injections per day will be collected each month. The changes in the number of insulin injections per day before and six months after the intervention of the two groups will be compared.
Time frame: From enrollment to the end of treatment at 6 months
The change in the number of anti-diabetic oral medications before and after the intervention between groups
the number of anti-diabetic oral medications will be collected each month. The change in the number of anti-diabetic oral medications before and six months after the intervention of the two groups will be compared
Time frame: From enrollment to the end of treatment at 6 months
The change in time in hyperglycemia over six months between groups: standard group and nutrition intervention group
The mean change in time in hyperglycemia in each group will be assessed and compared between groups.
Time frame: From enrollment to the end of treatment at 6 months
The change in time in hypoglycemia over six months between groups: standard group and nutrition intervention group
The mean change in time in hypoglycemia each groups will be assessed and compared across groups.
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: Yes — All de-identified individual participant data (IPD) collected during the study will be made publicly available upon reasonable request or through a designated open-access repository after publication of the main results. Data will be shared in compliance with ethical approvals and participant consent, ensuring that no personally identifiable information is disclosed.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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