Web-based Dietary Intervention for Diabetic Patients (myDIDeA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Monash University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Monash University
ClinicalTrials.gov Identifier:
NCT01246687
First received: November 22, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Intervention Studies
Behavior
Behavioral: e-Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • Change from Baseline in Dietary KAB Score at 6 months [ Time Frame: Baseline & 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.


Secondary Outcome Measures:
  • Change from Baseline in anthropometric measurements at 6 months [ Time Frame: Baseline & 6 months ] [ Designated as safety issue: No ]
    BMI, body fat percentage, waist circumference

  • Change from Baseline in anthropometric measurements at 12 months [ Time Frame: Baseline & 12 months ] [ Designated as safety issue: No ]
    BMI, body fat percentage, waist circumference

  • Change from Baseline in dietary practices at 6 months [ Time Frame: Baseline & 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)


Enrollment: 134
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)
Arms Assigned Interventions
Experimental: e-Intervention group
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246687

Locations
Malaysia
Hospital Selayang
Batu Caves, Selangor, Malaysia, 68100
Hospital Serdang
Kajang, Selangor, Malaysia, 43000
Hospital Putrajaya
Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia, 62250
Sponsors and Collaborators
Monash University
Investigators
Principal Investigator: Kia Fatt Quek, PhD Monash University (Sunway Campus)
  More Information

No publications provided by Monash University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joyce Tang / Head, Planning and Research Management, Monash University
ClinicalTrials.gov Identifier: NCT01246687     History of Changes
Other Study ID Numbers: MED2009-CM(SG)-004-QKF
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014