- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Dietary KAB Score at 6 months
Tidsram: 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
Tidsram: Baseline & 12 months
|
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
|
Baseline & 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in anthropometric measurements at 6 months
Tidsram: Baseline & 6 months
|
BMI, body fat percentage, waist circumference
|
Baseline & 6 months
|
|
Change from Baseline in anthropometric measurements at 12 months
Tidsram: Baseline & 12 months
|
BMI, body fat percentage, waist circumference
|
Baseline & 12 months
|
|
Change from Baseline in dietary practices at 6 months
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline & 12 months
|
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
|
Baseline & 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kia Fatt Quek, PhD, Monash University (Sunway Campus)
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MED2009-CM(SG)-004-QKF
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