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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

Tracking Information
First Submitted Date  ICMJE November 22, 2010
First Posted Date  ICMJE November 23, 2010
Last Update Posted Date December 27, 2017
Actual Study Start Date  ICMJE March 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-based Dietary Intervention for Diabetic Patients
Official Title  ICMJE Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Intervention Studies
  • Behavior
Intervention  ICMJE Behavioral: e-Intervention
Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
Study Arms  ICMJE
  • Experimental: e-Intervention group
    Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
    Intervention: Behavioral: e-Intervention
  • No Intervention: Control group
    Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2010)
134
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01246687
Other Study ID Numbers  ICMJE MED2009-CM(SG)-004-QKF
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amutha Ramadas, Monash University
Study Sponsor  ICMJE Monash University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kia Fatt Quek, PhD Monash University (Sunway Campus)
PRS Account Monash University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP