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Type 2 DiabetesNCT07598266

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

A study testing Nutrition intervention in people with Type 2 Diabetes, run by Cho Ray Hospital at 1 site in Vietnam.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Nutrition intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
1 siteVietnam
Study dates
8 Jun 2026to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • Cho Ray Hospital

    Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official 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

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.

Read more

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

Read the detailed description

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.

Conditions
Type 2 Diabetes
Being tested
Nutrition intervention
Keywords
nutrition education, educational program, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition interventionBehavioural

    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.

Study groups in NCT07598266
Study groupRoleWhat they receive
Standard groupNo interventionThe participants of this group will be given a nutrition booklet and follow the standard of care, which means the participants routinely have about 5 to 10-minute consultations with their doctors. During this time, the participants tell their doctors about how they feel physically, their doctors then examine the patients, educate them if necessary, and prescribe the tests and medications.
Nutrition Intervention groupExperimentalParticipants 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.
Receives: Behavioral: Nutrition intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 months

Secondary outcomes (16)
  1. Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control

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

    Measured: 3 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

  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

    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

    Measured: 3 months, and 6 months

  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

    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

    Measured: 3 months, and 6 months

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

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

    Measured: 6 months

  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

    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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

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

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

    Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start8 Jun 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
253 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07598266
Sponsor's protocol ID
ChoRay_OMIN_2026
Status last verified
Feb 2026
First submitted
19 Apr 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All the outcome-related data collected from the participant, which were described in the study protocol, will be shared. The data, which involves participants' identities or can be used to track their identities, will not be shared. The shared data will be published on a website that specializes in the data management chosen by the principal investigator.

Publications

  • Franz MJ, MacLeod J, Evert A, Brown C, Gradwell E, Handu D, Reppert A, Robinson M. Academy of Nutrition and Dietetics Nutrition Practice Guideline for Type 1 and Type 2 Diabetes in Adults: Systematic Review of Evidence for Medical Nutrition Therapy Effectiveness and Recommendations for Integration into the Nutrition Care Process. J Acad Nutr Diet. 2017 Oct;117(10):1659-1679. doi: 10.1016/j.jand.2017.03.022. Epub 2017 May 19. No abstract available.

    PubMed 28533169
  • Subhan FB, Fernando DN, Thorlakson J, Chan CB. Dietary Interventions for Type 2 Diabetes in South Asian Populations-A Systematic Review. Curr Nutr Rep. 2023 Mar;12(1):39-55. doi: 10.1007/s13668-022-00446-9. Epub 2022 Nov 29.

    PubMed 36443548
  • Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2022 Nov 1;45(11):2753-2786. doi: 10.2337/dci22-0034.

    PubMed 36148880

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition intervention in people with Type 2 Diabetes, run by Cho Ray Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07598266, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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