Web-based Dietary Intervention for Diabetic Patients (myDIDeA)
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ClinicalTrials.gov Identifier: NCT01246687 |
Recruitment Status :
Completed
First Posted : November 23, 2010
Last Update Posted : December 27, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 Intervention Studies Behavior | Behavioral: e-Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 134 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach |
Actual Study Start Date : | March 2010 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: e-Intervention group
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
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Behavioral: e-Intervention
Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients. |
No Intervention: Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
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- Change from Baseline in Dietary KAB Score at 6 months [ Time Frame: Baseline & 6 months ]Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
- Change from Baseline in Dietary KAB Score at 12 months [ Time Frame: Baseline & 12 months ]Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
- Change from Baseline in anthropometric measurements at 6 months [ Time Frame: Baseline & 6 months ]BMI, body fat percentage, waist circumference
- Change from Baseline in anthropometric measurements at 12 months [ Time Frame: Baseline & 12 months ]BMI, body fat percentage, waist circumference
- Change from Baseline in dietary practices at 6 months [ Time Frame: Baseline & 6 months ]Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
- Change from Baseline in dietary practices at 12 months [ Time Frame: Baseline & 12 months ]Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
- Change from Baseline in blood biomarkers at 6 months [ Time Frame: Baseline & 6 months ]HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
- Change from Baseline in blood biomarkers at 12 months [ Time Frame: Baseline & 12 months ]HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246687
Malaysia | |
Hospital Selayang | |
Batu Caves, Selangor, Malaysia, 68100 | |
Hospital Serdang | |
Kajang, Selangor, Malaysia, 43000 | |
Hospital Putrajaya | |
Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250 |
Principal Investigator: | Kia Fatt Quek, PhD | Monash University (Sunway Campus) |
Responsible Party: | Amutha Ramadas, Ms, Monash University |
ClinicalTrials.gov Identifier: | NCT01246687 |
Other Study ID Numbers: |
MED2009-CM(SG)-004-QKF |
First Posted: | November 23, 2010 Key Record Dates |
Last Update Posted: | December 27, 2017 |
Last Verified: | December 2017 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |