Web-based Dietary Intervention for Diabetic Patients (myDIDeA)
24 de dezembro de 2017 atualizado por: Amutha Ramadas, Monash University
Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach
The Internet holds promise for a wide-scale promotion of dietary and lifestyle behavioural change. Website-delivered interventions have a potentially broad population reach as it is available 24 hours, and could be hosted by both government and non-governmental agencies. To date, there is no published study focused on dietary behaviour change in adults with Type 2 Diabetes Mellitus (T2DM) via a website-based system.
myDIDeA was a 12-months two-armed randomised controlled trial conducted in three tertiary public hospitals in Klang Valley, Malaysia. The primary outcome was the Dietary Knowledge, Attitude and Behaviour (DKAB) score, while the secondary outcomes included the food intake, anthropometry measurements, blood pressure and resting heart rate, blood biomarkers and the Dietary Stages of Change (DSOC) score.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
The study was designed according to the recommendations of the CONSORT statement for randomised trials of non-pharmacologic treatment.
The study commenced in November 2009 after obtaining the ethical approvals from relevant authorities, and the trial has been registered with Clinicaltrials.gov
(NCT01246687).
After being screened for eligibility, 128 patients with Type 2 Diabetes Mellitus (T2DM) from the outpatient clinics at these hospitals were recruited into the study with informed consent.
After the baseline data collection, the participants were randomised into the e-intervention (n=66) or the control (n=62) group.
The e-intervention group received an intensive six-month dietary intervention through the study website, which was developed based on various established guidelines and recommendations but personalised according to the participants' DSOC, in addition to the usual standard treatment at the outpatient clinics.
In contrast, the control group received the usual standard treatment given to patients with T2DM, and did not receive the website login information, or any reinforcement via e-mail or SMS.
Data were collected at baseline, six months post-intervention and at 12 months follow-up.
A structured and pre-tested questionnaire was used for this purpose.
The anthropometry measurements, blood pressure and resting heart rate were measured at data collection.
Details on the blood biomarkers were obtained from the hospital medical records.
The statistical analysis revealed that myDIDeA was successful in improving overall DKAB score by improving the diabetes-related dietary knowledge and attitude of the participants.
Besides, the intervention programme also have successfully improved the DSOC score of the intervention group, suggesting the participants were indeed making small but significant progress in changing their dietary behaviour.
Improvement in the diet quality (improvement in vegetable intake and reduction in carbohydrate and protein intake), glycaemic control and total cholesterol have added credibility to this web-delivered intervention.
The process evaluation of the study website revealed that on the average each participant logged in the website once a week and spent 11 minutes at the website per visit.
The usability (facilitating conditions) scored the highest, while the acceptability (anxiety) scored the lowest.
Tipo de estudo
Intervencional
Inscrição (Real)
134
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.
Locais de estudo
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Selangor
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Batu Caves, Selangor, Malásia, 68100
- Hospital Selayang
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Kajang, Selangor, Malásia, 43000
- Hospital Serdang
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Wilayah Persekutuan Putrajaya
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Putrajaya, Wilayah Persekutuan Putrajaya, Malásia, 62250
- Hospital Putrajaya
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Mentally sound men and women who are > 18 years old.
- Literate with a fair command of English and/or Malay languages.
- Have access to the Internet at home, work or public place.
- Willing to access the web portal at least once every fortnight.
- Have been confirmed to have HbA1c of >7%.
- KAB score < 50% at baseline.
Exclusion Criteria:
- Pregnant, lactating or intend to become pregnant during the study period.
- Diagnosed with Type 1 Diabetes Mellitus (T1DM) or Gestational Diabetes Mellitus (GDM)
- Weighing not more than 150% of the desired weight for height.
- Any pre-existing condition compromising the quality of life or ability to participate according to protocol.
- Have severe complications (chronic heart disease, cerebrovascular disease, diagnosed HIV/AIDS, cancer, emphysema, chronic liver or kidney disease) that would affect the subjects' ability to follow the tailored advice.
- Enrolled in other clinical studies.
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: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: e-Intervention group
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
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Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
|
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Sem intervenção: Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in Dietary KAB Score at 6 months
Prazo: Baseline & 6 months
|
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
|
Baseline & 6 months
|
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Change from Baseline in Dietary KAB Score at 12 months
Prazo: Baseline & 12 months
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Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
|
Baseline & 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from Baseline in anthropometric measurements at 6 months
Prazo: Baseline & 6 months
|
BMI, body fat percentage, waist circumference
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Baseline & 6 months
|
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Change from Baseline in anthropometric measurements at 12 months
Prazo: Baseline & 12 months
|
BMI, body fat percentage, waist circumference
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Baseline & 12 months
|
|
Change from Baseline in dietary practices at 6 months
Prazo: Baseline & 6 months
|
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
|
Baseline & 6 months
|
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Change from Baseline in dietary practices at 12 months
Prazo: Baseline & 12 months
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Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
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Baseline & 12 months
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Change from Baseline in blood biomarkers at 6 months
Prazo: Baseline & 6 months
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HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
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Baseline & 6 months
|
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Change from Baseline in blood biomarkers at 12 months
Prazo: Baseline & 12 months
|
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
|
Baseline & 12 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Kia Fatt Quek, PhD, Monash University (Sunway Campus)
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
- Ramadas A, Chan CKY, Oldenburg B, Hussein Z, Quek KF. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes: changes in health cognitions and glycemic control. BMC Public Health. 2018 Jun 8;18(1):716. doi: 10.1186/s12889-018-5640-1.
- Ramadas A, Quek KF, Chan CK, Oldenburg B, Hussein Z. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA. BMC Public Health. 2011 May 21;11:359. doi: 10.1186/1471-2458-11-359.
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 (Real)
1 de março de 2010
Conclusão Primária (Real)
1 de junho de 2011
Conclusão do estudo (Real)
1 de dezembro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
22 de novembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de novembro de 2010
Primeira postagem (Estimativa)
23 de novembro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de dezembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de dezembro de 2017
Última verificação
1 de dezembro de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MED2009-CM(SG)-004-QKF
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