Nutrition education program for insulin-treated diabetes patients in Vietnam
Effectiveness of a Structured Nutrition Educational Program on Glycemic Control, Quality of Life, and Cardiovascular Risk in Patients With Uncontrolled Diabetes Using Multiple Daily Insulin Injections
This study is testing if a nutrition education program can help people with diabetes who take insulin improve their blood sugar levels and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cho Ray Hospital Academic / other |
| Locations | 1 site (Ho Chi Minh City, Vietnam) |
| Trial ID | NCT06985095 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a structured nutrition educational program for individuals with diabetes who require multiple daily insulin injections. Participants aged 18 to 70 with high blood sugar levels will be randomly assigned to either receive a nutrition booklet alone or the booklet along with four monthly lessons focused on diabetes management and nutrition. The study will assess changes in HbA1c levels, nutrition knowledge, quality of life, and other health metrics over the course of the intervention. It will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, from 2025 to 2026.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who use insulin at least twice daily and have an HbA1c level above 8%.
Not a fit: Patients with serious illnesses or those unable to adhere to the study protocol may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve blood sugar control and overall health for insulin-treated diabetes patients.
How similar studies have performed: Previous studies have shown that nutrition education can positively impact diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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.
Where this trial is running
Ho Chi Minh City, Vietnam
- Cho Ray Hospital — Ho Chi Minh City, Vietnam, Vietnam (Recruiting)
Study contacts
- Principal investigator: Na Ly Dau, MD — Cho Ray Hospital
- Study coordinator: Na Ly Dau, MD
- Email: Ly.Dau@lrz.uni-muenchen.de
- Phone: 0084379942392
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.