Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000062022
Ethics application status
Approved
Date submitted
16/12/2009
Date registered
19/01/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Using the Internet to support breastfeeding duration
Scientific title
Evaluating the use of an Internet intervention to sustain breastfeeding duration for primiparous and multiparous mothers in regional Western Australia (WA)
Secondary ID [1] 1265 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early cessation of breastfeeding 256414 0
Condition category
Condition code
Public Health 256587 256587 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be an individualised website that women in the intervention group can access to gain support to maintain breastfeeding.
Women will be able to log onto the website as often as they like to obtain breastfeeding information, watch a breastfeeding demonstration video, participate in a discussion forum with other mothers or email other registered online mothers as part of a virtual community. In addition, women experiencing difficulty will be able to contact the researcher directly via email for assistance.
The trial will run for 12 months.
Intervention code [1] 255707 0
Other interventions
Comparator / control treatment
The control group of women/mothers will not have access to the website but to the standard postnatal support already available.

In WA, all new mothers receive a universal schedule of visits with a Child Health Nurse. The first visit is most often in the home within 1 - 2 weeks postpartum. A follow up visit is held at the Child Health Clinic within 6 weeks postpartum.

Control mothers are also able to access any other services and information available to them e.g. the internet (other general sites, lactation consultant, Australian Breastfeeding Association).
Control group
Active

Outcomes
Primary outcome [1] 257475 0
Prevalence of breastfeeding assessed by survey question (online, telephone).
Timepoint [1] 257475 0
at 4, 10, 16, 22, 32, 40 and 52 weeks from the beginning of the intervention and at the age of the baby post partum (e.g 4 weeks, 10 weeks etc).
Secondary outcome [1] 262657 0
Utilisation of the website determined by website tracking statistics
Timepoint [1] 262657 0
Throughout the entire study (ie 12 months)

Eligibility
Key inclusion criteria
Mothers will be primiparous or multiparous, speak English, have had a normal pregnancy, have a new born infant less than two weeks old, and have access to a computer with Internet access at home.
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers will not be included if their child experienced serious illness and were transferred to Perth' major maternity hospital or neotal intensive care.

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)
Subjects will be randomly allocated to the control or intervention group by the computer as they register to be involved in the study.

The research officer will recruit participants while in hospital after the birth of their infant. The research officer will be unaware of the group allocation. The participant will only be allocated to the control or intervention group after they have registered to be part of the study.

Randomisation will be determined centrally by computer once the participant has registered to be involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Longitudinal. Information will be obtained prospectively at more than one time point.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256184 0
Government body
Name [1] 256184 0
Healthway Health Promotion Foundation
Country [1] 256184 0
Australia
Primary sponsor type
University
Name
Curtin University of Techonology
Address
GPO BOX U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 251527 0
None
Name [1] 251527 0
Address [1] 251527 0
Country [1] 251527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258293 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 258293 0
Ethics committee country [1] 258293 0
Australia
Date submitted for ethics approval [1] 258293 0
Approval date [1] 258293 0
16/06/2009
Ethics approval number [1] 258293 0
SPH-0005-2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30624 0
Address 30624 0
Country 30624 0
Phone 30624 0
Fax 30624 0
Email 30624 0
Contact person for public queries
Name 13871 0
Roslyn Giglia
Address 13871 0
WACHPR
School of Public Health
GPO Box u1987
Perth WA 6845
Country 13871 0
Australia
Phone 13871 0
+61 08 9266 7382
Fax 13871 0
+61 08 9266 2958
Email 13871 0
R.Giglia@exchange.curtin.edu.au
Contact person for scientific queries
Name 4799 0
Roslyn Giglia
Address 4799 0
WACHPR
School of Public Health
GPO Box u1987
Perth WA 6845
Country 4799 0
Australia
Phone 4799 0
+61 08 9266 7382
Fax 4799 0
+61 08 9266 2958
Email 4799 0
R.Giglia@exchange.curtin.edu.au

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
No additional documents have been identified.