We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Web-based Dietary Intervention for Diabetic Patients (myDIDeA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01246687
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Amutha Ramadas, Monash University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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

Detailed Description:
The study was designed according to the recommendations of the CONSORT statement for randomised trials of non-pharmacologic treatment. The study commenced in November 2009 after obtaining the ethical approvals from relevant authorities, and the trial has been registered with Clinicaltrials.gov (NCT01246687). After being screened for eligibility, 128 patients with Type 2 Diabetes Mellitus (T2DM) from the outpatient clinics at these hospitals were recruited into the study with informed consent. After the baseline data collection, the participants were randomised into the e-intervention (n=66) or the control (n=62) group. The e-intervention group received an intensive six-month dietary intervention through the study website, which was developed based on various established guidelines and recommendations but personalised according to the participants' DSOC, in addition to the usual standard treatment at the outpatient clinics. In contrast, the control group received the usual standard treatment given to patients with T2DM, and did not receive the website login information, or any reinforcement via e-mail or SMS. Data were collected at baseline, six months post-intervention and at 12 months follow-up. A structured and pre-tested questionnaire was used for this purpose. The anthropometry measurements, blood pressure and resting heart rate were measured at data collection. Details on the blood biomarkers were obtained from the hospital medical records. The statistical analysis revealed that myDIDeA was successful in improving overall DKAB score by improving the diabetes-related dietary knowledge and attitude of the participants. Besides, the intervention programme also have successfully improved the DSOC score of the intervention group, suggesting the participants were indeed making small but significant progress in changing their dietary behaviour. Improvement in the diet quality (improvement in vegetable intake and reduction in carbohydrate and protein intake), glycaemic control and total cholesterol have added credibility to this web-delivered intervention. The process evaluation of the study website revealed that on the average each participant logged in the website once a week and spent 11 minutes at the website per visit. The usability (facilitating conditions) scored the highest, while the acceptability (anxiety) scored the lowest.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change from Baseline in anthropometric measurements at 6 months [ Time Frame: Baseline & 6 months ]
    BMI, body fat percentage, waist circumference

  2. Change from Baseline in anthropometric measurements at 12 months [ Time Frame: Baseline & 12 months ]
    BMI, body fat percentage, waist circumference

  3. 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

  4. 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

  5. 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)

  6. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kia Fatt Quek, PhD Monash University (Sunway Campus)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases