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

17. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

253

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control
Tidsramme: 6 months
the change in Hba1c (%) from the baseline to 6 months, comparing intervention vs standard group
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cho Ray Hospital

Samarbejdspartnere

Ludwig-Maximilians - University of Munich

Efterforskere

  • Ledende efterforsker: Na Ly Dau, MD, Cho Ray Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. april 2027

Datoer for studieregistrering

Først indsendt

19. april 2026

Først indsendt, der opfyldte QC-kriterier

17. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ChoRay_OMIN_2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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