Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 2, intervention studies, behavior
Treatment e-intervention
Sponsor Monash University
Start date March 2010
End date June 2011
Trial size 134 participants
Trial identifier NCT01246687, MED2009-CM(SG)-004-QKF

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
e-intervention
Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
(No Intervention)
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.

Primary Outcomes

Measure
Change from Baseline in Dietary KAB Score at 6 months
time frame: Baseline & 6 months
Change from Baseline in Dietary KAB Score at 12 months
time frame: Baseline & 12 months

Secondary Outcomes

Measure
Change from Baseline in anthropometric measurements at 6 months
time frame: Baseline & 6 months
Change from Baseline in anthropometric measurements at 12 months
time frame: Baseline & 12 months
Change from Baseline in dietary practices at 6 months
time frame: Baseline & 6 months
Change from Baseline in dietary practices at 12 months
time frame: Baseline & 12 months
Change from Baseline in blood biomarkers at 6 months
time frame: Baseline & 6 months
Change from Baseline in blood biomarkers at 12 months
time frame: Baseline & 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach
Principal investigator Kia Fatt Quek, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Monash University.