Web-based Dietary Intervention for Diabetic Patients

NCT01246687 | Completed

• 1 other identifier: MED2009-CM(SG)-004-QKF
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2; Intervention Studies; Behavior

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Dietary KAB Score at 6 months

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

  Baseline & 6 months

• Change from Baseline in Dietary KAB Score at 12 months

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

  Baseline & 12 months

Secondary Outcomes (6)

• Change from Baseline in anthropometric measurements at 6 months

  Baseline & 6 months

• Change from Baseline in anthropometric measurements at 12 months

  Baseline & 12 months

• Change from Baseline in dietary practices at 6 months

  Baseline & 6 months

• Change from Baseline in dietary practices at 12 months

  Baseline & 12 months

• Change from Baseline in blood biomarkers at 6 months

  Baseline & 6 months

Study Arms (2)

e-Intervention group

EXPERIMENTAL

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

Behavioral: e-Intervention

Control group

NO INTERVENTION

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

Interventions

e-Intervention BEHAVIORAL

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

e-Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monash University: lead

Study Sites (3)

Hospital Putrajaya

Putrajaya, Putrajaya, 62250, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, 68100, Malaysia

Location

Hospital Serdang

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 29884161 DERIVED

• 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.

  PMID: 21599990 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kia Fatt Quek, PhD

  Monash University (Sunway Campus)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

MY (3)