Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes
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
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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Na Ly Dau, MD
- 電話番号：+49379942392
- メール：Ly.Dau@lrz.uni-muenchen.de
研究場所
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Ho Chi Minh City、ベトナム、700000
- Cho Ray Hospital
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コンタクト：
- Na Ly Dau, MD
- 電話番号：+49379942392
- メール：Ly.Dau@lrz.uni-muenchen.de
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主任研究者：
- Na Ly Dau, MD
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Standard group
The 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.
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実験的：Nutrition Intervention group
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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control
時間枠：6 months
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the change in Hba1c (%) from the baseline to 6 months, comparing intervention vs standard group
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
時間枠：3 months
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Change in HbA1c (%) from baseline to 3 months, comparing intervention vs standard group
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3 months
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Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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Difference of number of distinct anti-diabetic medication classes used per day after 3 months, and after 6 months, comparing the intervention vs control
時間枠：3 months, and 6 months
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Difference of number of distinct anti-diabetic medication classes used per day after 3 months, and after 6 months, comparing the intervention vs standard group
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3 months, and 6 months
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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
時間枠：3 months, and 6 months
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Differences in daily doses of each oral anti-diabetic medication and dyslipidemia medication after 3 months, and after 6 months, comparing the intervention vs standard group
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3 months, and 6 months
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Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs control
時間枠：6 months
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Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs standard group
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6 months
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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
時間枠：3 months and 6 months
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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 standard group
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3 months and 6 months
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Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
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3 months and 6 months
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Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control
時間枠：3 months and 6 months
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Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
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3 months and 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：6 months
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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 standard group.
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6 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Na Ly Dau, MD、Cho Ray Hospital
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ChoRay_OMIN_2026
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