Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000697583
Ethics application status
Approved
Date submitted
10/06/2015
Date registered
3/07/2015
Date last updated
3/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Developing an educational intervention for high risk women with Gestational Diabetes Mellitus (Eat for your baby)
Scientific title
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.
Secondary ID [1] 286880 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus in pregnant women 295285 0
Condition category
Condition code
Metabolic and Endocrine 295537 295537 0 0
Diabetes
Reproductive Health and Childbirth 295671 295671 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have developed an education program (a web-based program) with pictures of food and simple instructions that can be accessed at an information kiosk (touch screen computer) at the hospital diabetes clinic, home computer, and mobile phone. This educational program will be used by women with gestational diabetes and by health professional involved in their care.

Pregnant women who agree to take part will be assigned to a group: Intervention group and control group.

Group 1 (Intervention group) will be asked to use an online touch screen/ computer program which is located at diabetes clinic, or mobile phone or computer at their own homes. Women who decide to use the program at their homes, they will be given the website link and password to access to the program. The program will introduce women to information on healthy diet and healthy lifestyle (with pictures and simple instructions) for pregnant women with GDM. The program will take 15-30 minutes to complete. Women will be asked to complete a questionnaire after using the program. The clinic staff, dieticians, diabetes nurses will supervise women when they are using the touch screen computer at the clinic.

The overall duration of the web-based education program can be completed at one sitting and they can re-enter the website as often as they wish. There are 4 modules/lessons in the web-based program which include:

- Lesson 1: A step by step for testing blood glucose level
- Lesson 2: Outlines healthy food choices
- Lesson 3: Health habits - healthy life
- Lesson 4: Emotions, family and food

All lessons only use pictures and simple instruction that are very easy for women to understand. The program also includes some extra information for women. Such as, "what is gestational diabetes (GDM)?", "Healthy eating and exercise in GDM", "What to do if you're still hungry?", and "a guide to healthy shopping". This information also use images and simple instruction.
Intervention code [1] 292061 0
Treatment: Other
Comparator / control treatment
Group 2 (Comparator/Control group) will receive education at the clinic and will be required to complete a questionnaire at the end of the class.

The group education class provides for pregnant women with GDM (control group) at the clinic, it is a small class where it involves 5-8 pregnant women with GDM. The education on healthy diet, healthy exercise, healthy lifestyle and how to monitor blood sugar level will be presented to these women by dieticians and diabetes educators. The education class is one-off 2 hours class.
Control group
Active

Outcomes
Primary outcome [1] 295275 0
Women's weight following delivery as assessed using calibrated digital scales.
Timepoint [1] 295275 0
Timepoint at 8 weeks post delivery
Primary outcome [2] 295276 0
Newborn baby weight in normal range (>2500g - <4500g) - dichotomous outcome Yes/No assessed using calibrated digital scales.
Timepoint [2] 295276 0
Timepoint at birth, Baby weights at birth
Primary outcome [3] 295277 0
Normal Oral Glucose Tolerance Test (OGTT) - dichotomous outcome Yes/No.
- Normal fasting is < 5.1 mmol/L;
- 1-hour glucose following 75g oral glucose load is <10.0 mmol/L ;
- 2-hour glucose following 75g oral glucose load is <8.5mmol/L.
Timepoint [3] 295277 0
Timepoint at 8 weeks after delivery
Secondary outcome [1] 315253 0
Knowledge level on healthy diet and lifestyle habits following intervention, assessed by written test designed specifically for this study.
Timepoint [1] 315253 0
4 weeks after using an educational program

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
Sex
Females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/12/2014
Actual
10/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291445 0
Charities/Societies/Foundations
Name [1] 291445 0
Funding from Ian Potter Foundation
Country [1] 291445 0
Australia
Funding source category [2] 291496 0
Government body
Name [2] 291496 0
Diabetes Australia
Country [2] 291496 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Victoria University
College of Health and Biomedicine
PO Box 14428,
Melbourne 8001
Victoria
Country
Australia
Secondary sponsor category [1] 290174 0
Hospital
Name [1] 290174 0
Western Health Sunshine Hospital
Address [1] 290174 0
176 Furlong Road
St Albans
Victoria 3021
Country [1] 290174 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292996 0
Western Health Human Research Ethics Committee
Ethics committee address [1] 292996 0
Western Health Sunshine Hospital
176 Furlong Road
St Albans
Victoria 3021
Ethics committee country [1] 292996 0
Australia
Date submitted for ethics approval [1] 292996 0
26/08/2014
Approval date [1] 292996 0
27/10/2014
Ethics approval number [1] 292996 0
HREC/11/WH/81

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57950 0
Prof Mary Carolan-Olah
Address 57950 0
Victoria University
College of Health and Biomedicine
PO BOX 14428
Melbourne 8001
Victoria
Country 57950 0
Australia
Phone 57950 0
+61 3 9919 2325
Fax 57950 0
Email 57950 0
[email protected]
Contact person for public queries
Name 57951 0
Dr Padaphet Sayakhot
Address 57951 0
Victoria University
College of health and Biomedicine
PO BOX 14428
Melbourne 8001
Victoria
Country 57951 0
Australia
Phone 57951 0
+61 3 99192512
Fax 57951 0
Email 57951 0
[email protected]
Contact person for scientific queries
Name 57952 0
Dr Padaphet Sayakhot
Address 57952 0
Victoria University
College of Health and Biomedicine
PO BOX 14428
Melbourne 8001
Victoria
Country 57952 0
Australia
Phone 57952 0
+61 3 99192512
Fax 57952 0
Email 57952 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUse of a web-based educational intervention to improve knowledge of healthy diet and lifestyle in women with Gestational Diabetes Mellitus compared to standard clinic-based education.2016https://dx.doi.org/10.1186/s12884-016-0996-7
N.B. These documents automatically identified may not have been verified by the study sponsor.