- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01246687
Web-based Dietary Intervention for Diabetic Patients (myDIDeA)
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Selangor
-
Batu Caves, Selangor, Malaysia, 68100
- Hospital Selayang
-
Kajang, Selangor, Malaysia, 43000
- Hospital Serdang
-
-
Wilayah Persekutuan Putrajaya
-
Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
- Hospital Putrajaya
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Ingen inngripen: Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Dietary KAB Score at 6 months
Tidsramme: 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
Tidsramme: Baseline & 12 months
|
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
|
Baseline & 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in anthropometric measurements at 6 months
Tidsramme: Baseline & 6 months
|
BMI, body fat percentage, waist circumference
|
Baseline & 6 months
|
|
Change from Baseline in anthropometric measurements at 12 months
Tidsramme: Baseline & 12 months
|
BMI, body fat percentage, waist circumference
|
Baseline & 12 months
|
|
Change from Baseline in dietary practices at 6 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline & 12 months
|
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
|
Baseline & 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kia Fatt Quek, PhD, Monash University (Sunway Campus)
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MED2009-CM(SG)-004-QKF
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. .