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Diabetes Mellitus, Type 2myDIDeANCT01246687

Web-based Dietary Intervention for Diabetic Patients

A study testing e-Intervention in people with Diabetes Mellitus, Type 2 and Intervention Studies, run by Monash University at 3 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
e-Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
3 sitesMalaysia
Study dates
Mar 2010to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Malaysia3 sites

  • Hospital Selayang

    Batu Caves, Selangor, 68100

  • Hospital Serdang

    Kajang, Selangor, 43000

  • Hospital Putrajaya

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

About this study

Official title: Dietary Intervention Among Patients With Type 2 Diabetes Mellitus: An e-Approach

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.

Read the 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.

Being tested
e-Intervention
Medical subject headings
Diabetes Mellitus, Type 2, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-InterventionBehavioural

    Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.

Study groups in NCT01246687
Study groupRoleWhat they receive
e-Intervention groupExperimentalReceive stage-specific dietary intervention via the website \& standard care at the outpatient clinic.
Receives: Behavioral: e-Intervention
Control groupNo interventionContinue with the standard diabetes care at the outpatient clinic without getting access to the web-based intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Dietary KAB Score at 6 months

    Dietary Knowledge, Attitude \& Behaviour Score - assessed using 36-item questionnaire.

    Measured: Baseline & 6 months

  2. Change from Baseline in Dietary KAB Score at 12 months

    Dietary Knowledge, Attitude \& Behaviour Score - assessed using 36-item questionnaire.

    Measured: Baseline & 12 months

Secondary outcomes (6)

  1. Change from Baseline in anthropometric measurements at 6 months

    BMI, body fat percentage, waist circumference

    Measured: Baseline & 6 months

  2. Change from Baseline in anthropometric measurements at 12 months

    BMI, body fat percentage, waist circumference

    Measured: Baseline & 12 months

  3. Change from Baseline in dietary practices at 6 months

    Nutrient intake, dietary GI, supplement intake, food preparation \& eating out habit

    Measured: Baseline & 6 months

  4. Change from Baseline in dietary practices at 12 months

    Nutrient intake, dietary GI, supplement intake, food preparation \& eating out habit

    Measured: Baseline & 12 months

  5. Change from Baseline in blood biomarkers at 6 months

    HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)

    Measured: Baseline & 6 months

  6. Change from Baseline in blood biomarkers at 12 months

    HbA1c, fasting plasma glucose, lipid profile (data to be obtained from the medical records)

    Measured: Baseline & 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionJun 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01246687
Sponsor's protocol ID
MED2009-CM(SG)-004-QKF
Acronym
myDIDeA
Status last verified
Dec 2017
First submitted
22 Nov 2010
Last updated
27 Dec 2017
Results posted
No

Publications

  • 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.

    PubMed 29884161

  • 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.

    PubMed 21599990

Questions about this trial

What is this clinical trial studying?

A study testing e-Intervention in people with Diabetes Mellitus, Type 2 and Intervention Studies, run by Monash University at 3 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Dietary KAB Score at 6 months (time frame: Baseline & 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01246687, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.

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