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Web-based Dietary Intervention for Diabetic Patients (myDIDeA)

Primary Purpose

Diabetes Mellitus, Type 2, Intervention Studies, Behavior

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
e-Intervention
Sponsored by
Monash University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Selayang
  • Hospital Serdang
  • Hospital Putrajaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

e-Intervention group

Control group

Arm Description

Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.

Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.

Outcomes

Primary Outcome Measures

Change from Baseline in Dietary KAB Score at 6 months
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
Change from Baseline in Dietary KAB Score at 12 months
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.

Secondary Outcome Measures

Change from Baseline in anthropometric measurements at 6 months
BMI, body fat percentage, waist circumference
Change from Baseline in anthropometric measurements at 12 months
BMI, body fat percentage, waist circumference
Change from Baseline in dietary practices at 6 months
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
Change from Baseline in dietary practices at 12 months
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
Change from Baseline in blood biomarkers at 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
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)

Full Information

First Posted
November 22, 2010
Last Updated
December 24, 2017
Sponsor
Monash University
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1. Study Identification

Unique Protocol Identification Number
NCT01246687
Brief Title
Web-based Dietary Intervention for Diabetic Patients
Acronym
myDIDeA
Official Title
Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Intervention Studies, Behavior

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
e-Intervention group
Arm Type
Experimental
Arm Description
Receive stage-specific dietary intervention via the website & standard care at the outpatient clinic.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Continue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.
Intervention Type
Behavioral
Intervention Name(s)
e-Intervention
Intervention Description
Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
Primary Outcome Measure Information:
Title
Change from Baseline in Dietary KAB Score at 6 months
Description
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
Time Frame
Baseline & 6 months
Title
Change from Baseline in Dietary KAB Score at 12 months
Description
Dietary Knowledge, Attitude & Behaviour Score - assessed using 36-item questionnaire.
Time Frame
Baseline & 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in anthropometric measurements at 6 months
Description
BMI, body fat percentage, waist circumference
Time Frame
Baseline & 6 months
Title
Change from Baseline in anthropometric measurements at 12 months
Description
BMI, body fat percentage, waist circumference
Time Frame
Baseline & 12 months
Title
Change from Baseline in dietary practices at 6 months
Description
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
Time Frame
Baseline & 6 months
Title
Change from Baseline in dietary practices at 12 months
Description
Nutrient intake, dietary GI, supplement intake, food preparation & eating out habit
Time Frame
Baseline & 12 months
Title
Change from Baseline in blood biomarkers at 6 months
Description
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
Time Frame
Baseline & 6 months
Title
Change from Baseline in blood biomarkers at 12 months
Description
HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)
Time Frame
Baseline & 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kia Fatt Quek, PhD
Organizational Affiliation
Monash University (Sunway Campus)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Selayang
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hospital Serdang
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Hospital Putrajaya
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
29884161
Citation
Ramadas A, Chan CKY, Oldenburg B, Hussein Z, Quek KF. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes: changes in health cognitions and glycemic control. BMC Public Health. 2018 Jun 8;18(1):716. doi: 10.1186/s12889-018-5640-1.
Results Reference
derived
PubMed Identifier
21599990
Citation
Ramadas A, Quek KF, Chan CK, Oldenburg B, Hussein Z. Randomised-controlled trial of a web-based dietary intervention for patients with type 2 diabetes mellitus: study protocol of myDIDeA. BMC Public Health. 2011 May 21;11:359. doi: 10.1186/1471-2458-11-359.
Results Reference
derived

Learn more about this trial

Web-based Dietary Intervention for Diabetic Patients

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