Web-based Dietary Intervention for Diabetic Patients (myDIDeA)
Recruitment status was: Active, not recruiting
Introduction: 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.
Objective: To improve nutrition knowledge, attitude and behaviour (KAB) of the patients with T2DM through a 6-month dietary education programme delivered via a website. The secondary objectives of this study are to improve the participant's selected anthropometric measurements, dietary practices and biomarkers.
Hypothesis: A 6-month web-based dietary education programme will improve diabetic patients' nutrition KAB.
Methods: This is a two-armed matched-design randomized controlled trial (RCT) scheduled for two years in three public hospitals in Klang Valley. It will be carried out with quantitative techniques to measure the primary and secondary outcomes. Permission from relevant authorities has been obtained for this purpose. The targeted sample size is 100 subjects, with 50 subjects in each arm. The intervention group will be required to participate in a 6-month web-based dietary intervention, while the control group will receive the usual care given to diabetic patients. The subjects will then be followed up for another 6 months. Data collection will be held at baseline, 6-month and 12-month.
Expected results: The dietary recommendations are personalised according to the Stages of Change (SOC) the patient is in. The improvements in knowledge and attitude, and progress in SOC are expected to be reflected in the patients' dietary behaviour. Adoption of healthy dietary practices then is expected to be reflected on the anthropometric measurements and biomarkers. In the long run, the findings are expected to assist promotion of healthy diet and lifestyle to high-risk groups as well as Malaysian public in line with technology development. Moreover, the output from this research may serve as recommendation to Ministry of Health and other related NGOs on effective dietary intervention strategies for prevention of T2DM and complications which arise from the disease in this country.
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach|
- 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)
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
No Intervention: Control group
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246687
|Batu Caves, Selangor, Malaysia, 68100|
|Kajang, Selangor, Malaysia, 43000|
|Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250|
|Principal Investigator:||Kia Fatt Quek, PhD||Monash University (Sunway Campus)|