Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001091695
Ethics application status
Approved
Date submitted
30/09/2014
Date registered
14/10/2014
Date last updated
14/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
MumBubConnect: Can a Text Message a Week Improve Breastfeeding
Scientific title
MumBubConnect: Effect of a text messaging service delivered to women with infants less than three months old on breastfeeding practices
Secondary ID [1] 285417 0
Nil
Universal Trial Number (UTN)
U1111-1162-3565
Trial acronym
MBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 293163 0
Condition category
Condition code
Public Health 293442 293442 0 0
Other public health
Reproductive Health and Childbirth 293532 293532 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a proof of concept and not a randomised trial. A non-concurrent, prospective, comparison trial was conducted where we recruited 120 and 114 women into intervention and comparison groups respectively. Women in the intervention group received MumBubConnect, a text messaging service with automated responses delivered once a week for 8 weeks. Breastfeeding practice, self-efficacy, perceived social support and coping strategies were all observed and measured at baseline and at week nine. Women were sent a reminder text if they had not responded, women not responding to more than two text messages were phoned. The content of the text messages included an enquiry text to which the women responded with key words and received back information to help them problem solve with a helpline number or an affirmation. The messages were based around common problems identified in the literature and were developed through focus groups with women with infants and young children.
Intervention code [1] 290334 0
Behaviour
Comparator / control treatment
Women in the comparison group received their usual care and were sampled up to two years after the intervention group. Usual care in this study was defined as anything the women may have received including immediate postpartum midwife visitations, lactation consultants, accessing the Australian Breastfeeding Association or other resources. The women for the comparator group were recruited from August to October 2012.
Control group
Active

Outcomes
Primary outcome [1] 293262 0
Exclusive breastfeeding rates using indicators derived by WHO as determined in the Australian Infant Feeding Survey
Timepoint [1] 293262 0
Baseline and Week 9
Secondary outcome [1] 310690 0
Self efficacy as determined by the Breastfeeding Self-efficacy Scale
Timepoint [1] 310690 0
Baseline and Week 9
Secondary outcome [2] 310691 0
Coping either as active or emotions focussed coping as determined by the Ways of Coping Checklist
Timepoint [2] 310691 0
Baseline and Week 9

Eligibility
Key inclusion criteria
Women were eligible to participate if they were: over eighteen years of age; had an infant less than three months of age; were currently doing any breastfeeding ; did not have a diagnosed mental illness; and used a mobile phone (of any type).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 18 years of age
Diagnosed mental illness
No mobile phone

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible women were recruited for the intervention during a three week period in September and October and November 2010, via national broadcast media . (radio interviews and mainstream press release). Initially, women who self-selected into the intervention were going to be randomised into control and intervention groups but due to the overwhelming response for support, a control group was deemed unethical, therefore all women who registered were allocated to the intervention group as a convenience sample. As a result, a second group was recruited via social media to act as a comparison group between August and October 2012 using the same method of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The intervention group received the intervention and then a control group was recruited after all media interest had dissapated two years later. The intervention and control groups had similar recruitment strategies.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As a proof of concept the aim was to recruit as many women as possible in a short time period.

Statistical analyses were conducted using SPSS 21. T-tests were used to test for differences between groups for independent variables and changes in independent variables. Chi-square tests were used to test for differences between categories such as income and education. ANCOVA was used to test if the independent variable was having an effect and allowed the influence of the covariates to be controlled for during analysis. Hierarchical regression was used to investigate change in breastfeeding outcome, between groups, adjusting for co-variates. When controlling for covariates, factors that were significant at the bivariate level were adjusted for in the model

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2010
Actual
15/09/2010
Date of last participant enrolment
Anticipated
30/10/2012
Actual
30/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290022 0
Government body
Name [1] 290022 0
partially funded by a grant from the Queensland Government Office of Liquor and Gaming Regulation, Community Benefit Fund
Country [1] 290022 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 288710 0
None
Name [1] 288710 0
Address [1] 288710 0
Country [1] 288710 0
Other collaborator category [1] 278164 0
Other
Name [1] 278164 0
Australian Breastfeeding Association QLD Branch
Address [1] 278164 0
Shop 2A, 26 Eva Street Coorparoo QLD 4151
Country [1] 278164 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291730 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 291730 0
Ethics committee country [1] 291730 0
Date submitted for ethics approval [1] 291730 0
Approval date [1] 291730 0
22/10/2009
Ethics approval number [1] 291730 0
1000000568, 1100000234

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

Contacts
Principal investigator
Name 51766 0
A/Prof Danielle Gallegos
Address 51766 0
School of Exercise and Nutrition Sciences
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country 51766 0
Australia
Phone 51766 0
+61 7 3138 5799
Fax 51766 0
Email 51766 0
danielle.gallegos@qut.edu.au
Contact person for public queries
Name 51767 0
Danielle Gallegos
Address 51767 0
School of Exercise and Nutrition Sciences
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country 51767 0
Australia
Phone 51767 0
+61 7 3138 5799
Fax 51767 0
Email 51767 0
danielle.gallegos@qut.edu.au
Contact person for scientific queries
Name 51768 0
Danielle Gallegos
Address 51768 0
School of Exercise and Nutrition Sciences
Queensland University of Technology
Victoria Park Rd
Kelvin Grove QLD 4059
Country 51768 0
Australia
Phone 51768 0
+61 7 3138 5799
Fax 51768 0
Email 51768 0
danielle.gallegos@qut.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
SourceTitleYear of PublicationDOI
EmbaseCan a text message a week improve breastfeeding?.2014https://dx.doi.org/10.1186/s12884-014-0374-2
N.B. These documents automatically identified may not have been verified by the study sponsor.