Evaluation of a Structured Nutrition Educational Program in Insulin-treated Diabetic Patients in Vietnam

NCT06985095 | Recruiting DMC

• 1 other identifier: ChorayMUIN2025
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 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 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

Conditions

Diabetes Mellitus

Keywords

nutrition educational program; diabetes; multiple daily injection insulin users

Outcome Measures

Primary Outcomes (1)

• 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.

  For enrollment to the end of study at 6 months

Secondary Outcomes (8)

• The changes in quality of life after six months of follow-up within and between groups

  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

  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

  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

  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

  From enrollment to the end of treatment at 6 months

Other Outcomes (6)

• The change in total daily insulin dose before and after the intervention between groups

  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

  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

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Standard group

NO INTERVENTION

Participants in this arm only receive a nutrition booklet, written and designed by researchers. They don't join the lessons with the researcher.

Nutrition Intervention group

EXPERIMENTAL

Intervention group receives the same booklet and attends four monthly lessons with a researcher about healthy eating for diabetes.

Other: Nutrition educational program

Interventions

Nutrition educational program OTHER

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.

Nutrition Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People between 18 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 8%.
• People who are currently using at least two insulin injections a day or have just started a daily multiple insulin injection plan because their diabetes is not well controlled.

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.

Sponsors & Collaborators

• Cho Ray Hospital: lead

Study Sites (1)

Cho Ray Hospital

Ho Chi Minh City, Vietnam, 700000, Vietnam

RECRUITING

Related Publications (15)

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  PMID: 20647285 BACKGROUND

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  PMID: 27951578 BACKGROUND

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  PMID: 21378215 BACKGROUND

• Cadario F, Prodam F, Pasqualicchio S, Bellone S, Bonsignori I, Demarchi I, Monzani A, Bona G. Lipid profile and nutritional intake in children and adolescents with Type 1 diabetes improve after a structured dietician training to a Mediterranean-style diet. J Endocrinol Invest. 2012 Feb;35(2):160-8. doi: 10.3275/7755. Epub 2011 May 27.

  PMID: 21623150 BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Na Ly Dau, MD

  Cho Ray Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Ly Dau, MD

CONTACT

0084379942392; Ly.Dau@lrz.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 22, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available during

Locations

VN (1)