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Trial from ANZCTR

Use of a web-based educational intervention to improve healthy diet and lifestyle habits in high risk women with Gestational Diabetes Mellitus, in comparison to standard clinic-based education.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 3/7/2015)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615000697583

Date registered

03 July 2015

Health condition

Gestational Diabetes Mellitus in pregnant women

Recruitment countries

Australia

Recruitment site location(s) (State)

Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

10 December 2014

Ethics application status

Approved

Brief summary

Objectives: The approved project aimed to develop an effective educational program for use by Australian women with gestational diabetes mellitus (GDM) and by health professionals involved in their care. Educational materials from this project include an information booklet, a web-based program that can be accessed at an information kiosk (touch screen computer) at the hospital diabetes clinic, home PCs, and mobile technologies. Educational materials are initially available in English and Vietnamese languages. Programs contain culturally appropriate information such as typical food for the different ethnic groups, relevant in the area.
Methods: Pregnant women aged 18-45 years with GDM who have a singleton pregnancy, are eligible to participate in this study. Women who agree to participate in the study will be given a participant information sheet and consent form. Participants will be recruited from the Pregnancy diabetes Clinic, at Sunshine Hospital and introduced to the GDM educational modules using the touch screen computer located in the clinic. Participants will also be given the URL to access to the program and they can learn the modules at home by using their home PCs, mobile phones, or tablets. At the end of the 4 weeks programs, participants will be asked to complete the questionnaire. The final result will be analysed by using statistic software SPSS v. 20. An appropriate statistical analysis will be used to find out the effectiveness of a web-based educational program on women's knowledge of GDM, including the influence of the program on weights of the women after delivery, baby weights and blood glucose level after delivery. The biostatistician will be consulted when the study is published.

Eligibility

Key inclusion criteria

Participants in both groups 1 and 2 are expected to have the same criteria. Pregnant women who are aged between 18-45 years old, diagnosed with GDM, singleton pregnancy, attended pregnancy diabetes clinic at Sunshine Hospital, will be asked to participate in the study.

Minimum age

18 Years

Maximum age

45 Years

Gender

Females

Key exclusion criteria

Pregnant women who had pre-existing diabetes (types 1 and 2), are unable to write and understand English, women with a cognitive impairment, an intellectual disability or a mental illness, and women dependent on medical care (eg, anti-depressants, or any psychiatric medication)

Contact details and further information

Primary Sponsor

Type: University
Name: Victoria University
Address: Victoria University
College of Health and Biomedicine
PO Box 14428,
Melbourne 8001
Victoria

Country: Australia

Contact person for information and recruitment

Dr Padaphet Sayakhot
Victoria University
College of health and Biomedicine
PO BOX 14428
Melbourne 8001
Victoria
Australia
+61 3 99192512
padaphet.sayakhot@vu.edu.au