Evaluation of a Structured Nutrition Educational Program Among Patients With Type 2 Diabetes
17 de maio de 2026 atualizado por: 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
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
253
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Na Ly Dau, MD
- Número de telefone: +49379942392
- E-mail: Ly.Dau@lrz.uni-muenchen.de
Locais de estudo
-
-
-
Ho Chi Minh City, Vietnã, 700000
- Cho Ray Hospital
-
Contato:
- Na Ly Dau, MD
- Número de telefone: +49379942392
- E-mail: Ly.Dau@lrz.uni-muenchen.de
-
Investigador principal:
- Na Ly Dau, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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.
|
|
|
Experimental: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Hba1c (%) from baseline to 6 months, comparing intervention vs control
Prazo: 6 months
|
the change in Hba1c (%) from the baseline to 6 months, comparing intervention vs standard group
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in HbA1c (%) from baseline to 3 months, comparing intervention vs control
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Na Ly Dau, MD, Cho Ray Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
30 de abril de 2027
Conclusão do estudo (Estimado)
30 de abril de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
19 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de maio de 2026
Primeira postagem (Real)
20 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de maio de 2026
Última verificação
1 de fevereiro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ChoRay_OMIN_2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Critérios de acesso de compartilhamento 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
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .