Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes
1 other identifier
interventional
253
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Jun 2026
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2026
CompletedFirst Posted
Study publicly available on registry
May 20, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
Study Completion
Last participant's last visit for all outcomes
April 30, 2027
May 20, 2026
February 1, 2026
11 months
April 19, 2026
May 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
6 months
Secondary Outcomes (16)
Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
3 months
Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs control
3 months and 6 months
Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs control
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 control
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 control
3 months, and 6 months
- +11 more secondary outcomes
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.
6 months
Study Arms (2)
Standard group
NO 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 group
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cho Ray Hospitallead
- Ludwig-Maximilians - University of Munichcollaborator
Study Sites (1)
Cho Ray Hospital
Ho Chi Minh City, 700000, Vietnam
Related Publications (3)
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.
PMID: 28533169BACKGROUNDSubhan 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.
PMID: 36443548BACKGROUNDDavies 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.
PMID: 36148880BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Na Ly Dau, MD
Cho Ray Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 19, 2026
First Posted
May 20, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
May 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Access Criteria
- The public will be able to access the IPD and supporting information; they need to log into the website. All the shared information will be available to the public
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.