Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes
17. mai 2026 oppdatert 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
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
253
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Na Ly Dau, MD
- Telefonnummer: +49379942392
- E-post: Ly.Dau@lrz.uni-muenchen.de
Studiesteder
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-
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Ho Chi Minh City, Vietnam, 700000
- Cho Ray Hospital
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Ta kontakt med:
- Na Ly Dau, MD
- Telefonnummer: +49379942392
- E-post: Ly.Dau@lrz.uni-muenchen.de
-
Hovedetterforsker:
- Na Ly Dau, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Na Ly Dau, MD, Cho Ray Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
30. april 2027
Studiet fullført (Antatt)
30. april 2027
Datoer for studieregistrering
Først innsendt
19. april 2026
Først innsendt som oppfylte QC-kriteriene
17. mai 2026
Først lagt ut (Faktiske)
20. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2026
Sist bekreftet
1. februar 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ChoRay_OMIN_2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .