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NCT Number: NCT07598266

Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cho Ray Hospital

Ho Chi Minh City, 700000, Vietnam

Location contact

Na Ly Dau, MD

CONTACT

[email protected]

+49379942392

Na Ly Dau, MD

PRINCIPAL_INVESTIGATOR

About this study

This study will involve 253 people with diabetes who currently uses only oral anti-diabetic medications or in combination with basal insulin without their glycemia within the target range.

The study will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, and will run from 2026 to 2027. 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, a meeting with the researcher will be planned on the day of their next consultation. During this meeting, the patients will be screened for their eligibility.

On the screening day, the patients will have their blood tests to check their sugar, HbA1c, cholesterol, and kidney function as part of their routine visit and have a usual consultation with their doctor. If the patients meet all the criteria and agree to take part in, the patients will sign the consent form and take short tests on nutrition related knowledge, attitude, and behavior questionnaire designed and evaluated by the researcher.

After that, the patients 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.

During the 6-month study period, all participants will have blood tests every 3 months to check HbA1c, fasting sugar, and lipid; the participants will be asked monthly about any low blood sugar episodes; their weight and waist size will be measured every 3 months, and their height will be measured at the start of the study. The participants will be interviewed with the nutrition related knowledge-attitude-behavior questionnaire again after 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrition Intervention

Behavioral

Experimental: Nutrition intervention group Arm Description: 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-minute presentation delivered by the researcher using visual aids, such as slides and educational images, a 15-minute Q and A section, and 20 minutes of working on group assignments. 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.

Primary outcomes

  1. Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control

    Time frame: 6 months

    the change in Hba1c (%) from the baseline to 6 months, comparing intervention vs standard group

Secondary outcomes

  1. Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control

    Time frame: 3 months

    Change in HbA1c (%) from baseline to 3 months, comparing intervention vs standard group

  2. Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs standard group

  3. Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups

  4. Difference of number of distinct anti-diabetic medication classes used per day after 3 months, and after 6 months, comparing the intervention vs control

    Time frame: 3 months, and 6 months

    Difference of number of distinct anti-diabetic medication classes used per day after 3 months, and after 6 months, comparing the intervention vs standard group

  5. Differences in daily doses of each oral anti-diabetic medication and dyslipidemia medication after 3 months, and after 6 months, comparing the intervention vs control

    Time frame: 3 months, and 6 months

    Differences in daily doses of each oral anti-diabetic medication and dyslipidemia medication after 3 months, and after 6 months, comparing the intervention vs standard group

  6. Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs control

    Time frame: 6 months

    Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs standard group

  7. Difference in possible self-reported hypoglycemia episodes recorded in the previous month from baseline to 3 months, and to 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Difference in possible self-reported hypoglycemia episodes recorded in the previous month from baseline to 3 months, and to 6 months, comparing the intervention vs standard group

  8. Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs standard group

  9. Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs standard group

  10. Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group

  11. Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs standard group

  12. Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group

  13. Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group

  14. Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs standard groups

  15. Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups

  16. Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control

    Time frame: 3 months and 6 months

    Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups

Other outcomes

  1. Difference in cost-effectiveness ratios (monthly per-patient cost for diabetic care per unit of improvement in glycemic control) after six months, comparing the intervention vs control.

    Time frame: 6 months

    Difference in cost-effectiveness ratios (monthly per-patient cost for diabetic care per unit of improvement in glycemic control) after six months, comparing the intervention vs standard group.

Study contacts

Contact information is provided by the study sponsor or research team.

Na Ly Dau, MD

CONTACT

[email protected]

+49379942392

Sponsors and collaborators

Lead sponsor

Cho Ray Hospital

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

Evaluation of a Structured Nutrition Education Program for Patients With Type 2 Diabetes Who Have Not Achieved Glycemic Goals Under Oral Anti-diabetic Medications or in Combination With Basal Insulin in Vietnam

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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