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

17 maj 2026 uppdaterad av: 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

253

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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.
Experimentell: 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.
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control
Tidsram: 6 months
the change in Hba1c (%) from the baseline to 6 months, comparing intervention vs standard group
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cho Ray Hospital

Samarbetspartners

Ludwig-Maximilians - University of Munich

Utredare

  • Huvudutredare: Na Ly Dau, MD, Cho Ray Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

30 april 2027

Avslutad studie (Beräknad)

30 april 2027

Studieregistreringsdatum

Först inskickad

19 april 2026

Först inskickad som uppfyllde QC-kriterierna

17 maj 2026

Första postat (Faktisk)

20 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 maj 2026

Senast verifierad

1 februari 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ChoRay_OMIN_2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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