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Web-based Dietary Intervention for Diabetic Patients (myDIDeA)

24 de diciembre de 2017 actualizado 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.

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

134

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Selangor
      • Batu Caves, Selangor, Malasia, 68100
        • Hospital Selayang
      • Kajang, Selangor, Malasia, 43000
        • Hospital Serdang
    • Wilayah Persekutuan Putrajaya
      • Putrajaya, Wilayah Persekutuan Putrajaya, Malasia, 62250
        • Hospital Putrajaya

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: e-Intervention group
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
Sin intervención: Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Dietary KAB Score at 6 months
Periodo de tiempo: Baseline & 6 months
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
Baseline & 6 months
Change from Baseline in Dietary KAB Score at 12 months
Periodo de tiempo: Baseline & 12 months
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
Baseline & 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in anthropometric measurements at 6 months
Periodo de tiempo: Baseline & 6 months
BMI, body fat percentage, waist circumference
Baseline & 6 months
Change from Baseline in anthropometric measurements at 12 months
Periodo de tiempo: Baseline & 12 months
BMI, body fat percentage, waist circumference
Baseline & 12 months
Change from Baseline in dietary practices at 6 months
Periodo de tiempo: Baseline & 6 months
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
Baseline & 6 months
Change from Baseline in dietary practices at 12 months
Periodo de tiempo: Baseline & 12 months
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
Baseline & 12 months
Change from Baseline in blood biomarkers at 6 months
Periodo de tiempo: Baseline & 6 months
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
Baseline & 6 months
Change from Baseline in blood biomarkers at 12 months
Periodo de tiempo: Baseline & 12 months
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
Baseline & 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Kia Fatt Quek, PhD, Monash University (Sunway Campus)

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2010

Finalización primaria (Actual)

1 de junio de 2011

Finalización del estudio (Actual)

1 de diciembre de 2011

Fechas de registro del estudio

Enviado por primera vez

22 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

22 de noviembre de 2010

Publicado por primera vez (Estimar)

23 de noviembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de diciembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

24 de diciembre de 2017

Última verificación

1 de diciembre de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • MED2009-CM(SG)-004-QKF

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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