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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Nutrition intervention
  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

Первичные конечные точки

• Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control [Срок оценки: 3 months]
• Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs control [Срок оценки: 3 months and 6 months]
• Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs control [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 3 months, and 6 months]
• Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs control [Срок оценки: 6 months]
• 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 [Срок оценки: 3 months and 6 months]
• Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs control [Срок оценки: 3 months and 6 months]
• Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs control [Срок оценки: 3 months and 6 months]
• Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control [Срок оценки: 3 months and 6 months]
• Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs control [Срок оценки: 3 months and 6 months]
• Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control [Срок оценки: 3 months and 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Cho Ray Hospital — Ho Chi Minh City

Публикации

• 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.20 PMID 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. PMID 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. PMID 36148880

Идентификаторы

NCT: NCT07598266 · ChoRay_OMIN_2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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