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

17. května 2026 aktualizováno: Ly Na Dau, Cho Ray Hospital

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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

253

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Cho Ray Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Na Ly Dau, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: 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.
Experimentální: 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.
Behaviorální: 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 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control
Časové okno: 6 months
the change in Hba1c (%) from the baseline to 6 months, comparing intervention vs standard group
6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
Časové okno: 3 months
Change in HbA1c (%) from baseline to 3 months, comparing intervention vs standard group
3 months
Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Change in BMI from baseline to 3 months and 6 months, comparing the intervention vs standard group
3 months and 6 months
Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Differences of total daily insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
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
Časové okno: 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 standard group
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
Časové okno: 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 standard group
3 months, and 6 months
Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs control
Časové okno: 6 months
Changes in nutrition-related knowledge, attitude and behavior score from baseline to 6 months, comparing the intervention vs standard group
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
Časové okno: 3 months and 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 standard group
3 months and 6 months
Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Change in waist circumference from baseline to 3 months and 6 months, comparing the intervention vs standard group
3 months and 6 months
Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Change in fasting blood glucose from baseline to 3 months and 6 months, comparing the intervention vs standard group
3 months and 6 months
Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Change in LDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
3 months and 6 months
Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Change in Total triglyceride from baseline to 3 months and 6 months, comparing the intervention vs standard group
3 months and 6 months
Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Change in total cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
3 months and 6 months
Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Change in HDL cholesterol from baseline to 3 months and 6 months, comparing the intervention vs standard group
3 months and 6 months
Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Differences of daily number of insulin injections after 3 months and after 6 months, comparing the intervention vs standard groups
3 months and 6 months
Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Differences of total daily slow-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
3 months and 6 months
Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs control
Časové okno: 3 months and 6 months
Differences of total daily fast-acting insulin dose after 3 months and after 6 months, comparing the intervention vs standard groups
3 months and 6 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 6 months
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.
6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Cho Ray Hospital

Spolupracovníci

Ludwig-Maximilians - University of Munich

Vyšetřovatelé

  • Vrchní vyšetřovatel: Na Ly Dau, MD, Cho Ray Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

30. dubna 2027

Dokončení studie (Odhadovaný)

30. dubna 2027

Termíny zápisu do studia

První předloženo

19. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

17. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. května 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ChoRay_OMIN_2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

All the outcome-related data collected from the participant, which were described in the study protocol, will be shared. The data, which involves participants' identities or can be used to track their identities, will not be shared. The shared data will be published on a website that specializes in the data management chosen by the principal investigator.

Kritéria přístupu pro sdílení IPD

The public will be able to access the IPD and supporting information; they need to log into the website. All the shared information will be available to the public

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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