Evaluation of a Structured Nutrition Educational Program in Insulin-treated Diabetic Patients in Vietnam
NCT ID: NCT06985095
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
115 participants
INTERVENTIONAL
2025-04-04
2026-12-01
Brief Summary
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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
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Detailed Description
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The study will take place at Cho Ray Hospital in Ho Chi Minh City, Vietnam, and will run from 2025 to the end of 2026. 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, they'll be asked to keep a food diary for three days before their screening.
On the screening day, they'll sign a short consent form, get blood tests to check their sugar, HbA1c, cholesterol, and kidney function, talk with a nutrition researcher about their food diary, and have a usual consultation with their doctor. If they meet all the criteria and agree to take part, they'll sign the full consent form and take short tests on nutrition knowledge and quality of life. The quality of life questionnaire used is the SF-36 questionnaire, and nutrition knowledge is assessed using the Diabetes-related Nutrition Knowledge Questionnaire (DRNK-Q).
After that, they 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. In each group, 10 participants will also wear a flash glucose monitor (a small device that checks sugar levels without finger pricks) three times: at the beginning, after 3 months, and after 6 months. These participants will be selected based on age, HbA1c level, ability to use the device, and whether they often experience low blood sugar.
During the 6-month study period, all participants will have blood tests every 3 months to check HbA1c, fasting sugar, and lipid; they will be asked monthly about any low blood sugar episodes; they will repeat the nutrition and quality of life tests at 6 months; their weight and waist size will be measured every 3 months, and their height will be measured at the start of the study
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard group
Participants in this arm only receive a nutrition booklet, written and designed by researchers. They don't join the lessons with the researcher.
No interventions assigned to this group
Nutrition Intervention group
Intervention group receives the same booklet and attends four monthly lessons with a researcher about healthy eating for diabetes.
Nutrition educational program
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.
Interventions
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Nutrition educational program
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Cho Ray Hospital
OTHER
Responsible Party
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Ly Na Dau
Endocrinologist
Principal Investigators
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Na Ly Dau, MD
Role: PRINCIPAL_INVESTIGATOR
Cho Ray Hospital
Locations
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Cho Ray Hospital
Ho Chi Minh City, Vietnam, Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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Bowen ME, Cavanaugh KL, Wolff K, Davis D, Gregory RP, Shintani A, Eden S, Wallston K, Elasy T, Rothman RL. The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education. Patient Educ Couns. 2016 Aug;99(8):1368-76. doi: 10.1016/j.pec.2016.03.017. Epub 2016 Mar 19.
Speight J, Amiel SA, Bradley C, Heller S, Oliver L, Roberts S, Rogers H, Taylor C, Thompson G. Long-term biomedical and psychosocial outcomes following DAFNE (Dose Adjustment For Normal Eating) structured education to promote intensive insulin therapy in adults with sub-optimally controlled Type 1 diabetes. Diabetes Res Clin Pract. 2010 Jul;89(1):22-9. doi: 10.1016/j.diabres.2010.03.017. Epub 2010 Apr 18.
Trento M, Trinetta A, Kucich C, Grassi G, Passera P, Gennari S, Paganin V, Tedesco S, Charrier L, Cavallo F, Porta M. Carbohydrate counting improves coping ability and metabolic control in patients with Type 1 diabetes managed by Group Care. J Endocrinol Invest. 2011 Feb;34(2):101-5. doi: 10.1007/BF03347038. Epub 2010 May 3.
Schmidt S, Schelde B, Norgaard K. Effects of advanced carbohydrate counting in patients with type 1 diabetes: a systematic review. Diabet Med. 2014 Aug;31(8):886-96. doi: 10.1111/dme.12446.
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.
Franz MJ, Monk A, Barry B, McClain K, Weaver T, Cooper N, Upham P, Bergenstal R, Mazze RS. Effectiveness of medical nutrition therapy provided by dietitians in the management of non-insulin-dependent diabetes mellitus: a randomized, controlled clinical trial. J Am Diet Assoc. 1995 Sep;95(9):1009-17. doi: 10.1016/S0002-8223(95)00276-6.
Coppell KJ, Kataoka M, Williams SM, Chisholm AW, Vorgers SM, Mann JI. Nutritional intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised controlled trial. BMJ. 2010 Jul 20;341:c3337. doi: 10.1136/bmj.c3337.
Kitajima Y, Mikami N, Hyodo T, Hida M, Kawakami J. Carbohydrate Counting: A Simple Method of Dietary Management for Glycemic Control in Japanese Diabetic Hemodialysis Patients. Contrib Nephrol. 2017;189:262-269. doi: 10.1159/000451045. Epub 2016 Dec 12.
Laurenzi A, Bolla AM, Panigoni G, Doria V, Uccellatore A, Peretti E, Saibene A, Galimberti G, Bosi E, Scavini M. Effects of carbohydrate counting on glucose control and quality of life over 24 weeks in adult patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized, prospective clinical trial (GIOCAR). Diabetes Care. 2011 Apr;34(4):823-7. doi: 10.2337/dc10-1490. Epub 2011 Mar 4.
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.
Powers MA, Gal RL, Connor CG, Mangan M, Maahs DM, Clements MA, Mayer-Davis EJ. Eating patterns and food intake of persons with type 1 diabetes within the T1D exchange. Diabetes Res Clin Pract. 2018 Jul;141:217-228. doi: 10.1016/j.diabres.2018.05.011. Epub 2018 May 26.
DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial. BMJ. 2002 Oct 5;325(7367):746. doi: 10.1136/bmj.325.7367.746.
Andrews RC, Cooper AR, Montgomery AA, Norcross AJ, Peters TJ, Sharp DJ, Jackson N, Fitzsimons K, Bright J, Coulman K, England CY, Gorton J, McLenaghan A, Paxton E, Polet A, Thompson C, Dayan CM. Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial. Lancet. 2011 Jul 9;378(9786):129-39. doi: 10.1016/S0140-6736(11)60442-X. Epub 2011 Jun 24.
Franz MJ, Powers MA, Leontos C, Holzmeister LA, Kulkarni K, Monk A, Wedel N, Gradwell E. The evidence for medical nutrition therapy for type 1 and type 2 diabetes in adults. J Am Diet Assoc. 2010 Dec;110(12):1852-89. doi: 10.1016/j.jada.2010.09.014.
Holt RIG, DeVries JH, Hess-Fischl A, Hirsch IB, Kirkman MS, Klupa T, Ludwig B, Norgaard K, Pettus J, Renard E, Skyler JS, Snoek FJ, Weinstock RS, Peters AL. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2021 Dec;64(12):2609-2652. doi: 10.1007/s00125-021-05568-3.
Other Identifiers
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ChorayMUIN2025
Identifier Type: -
Identifier Source: org_study_id
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