Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622001208796
Ethics application status
Approved
Date submitted
20/07/2021
Date registered
8/09/2022
Date last updated
8/09/2022
Date data sharing statement initially provided
8/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Marri gudjada project: Improving the nutrition of aboriginal infants using peer support workers
Scientific title
The impact of breastfeeding peer support on nutrition of Aboriginal infants
Secondary ID [1] 304728 0
Nil
Universal Trial Number (UTN)
U1111-1267-4876
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 322749 0
Infant Nutrition 322750 0
Indigenous Health 322751 0
Condition category
Condition code
Diet and Nutrition 320341 320341 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will evaluate the effect of scheduled breastfeeding peer support for and by Aboriginal women, on breastfeeding initiation and prevalence of exclusive breastfeeding at six weeks, four months and six months post–birth. Survey data will be collated from participants via phone or email. Our intervention will utilise both face-to-face peer support for and by Aboriginal women and employ innovative aspects such as social media, video & telephone calls by Aboriginal peer workers for a period of six months postnatally.
Aboriginal peer support workers will be employed 3 days a week for 3 years at each intervention site (n=3). Six maternal and child health services in NSW will be recruited and randomised to intervention (peer-support worker) or control (usual care). Peer-support workers will aim to provide weekly contact with participants for the first 6 weeks and participants can access the peer-support worker for up to 6 months.
Interviews and/or focus groups with members of the community and service staff will be completed pre and post intervention for qualitiative evaluation.
This project will also develop educational videos to support breastfeeding which will then be evaluated through small focus groups or interviews using yarning methodology. Videos will aim to be developed and evaluated in 2023 and include mothers who are pregnant and those with babies and children.
Intervention code [1] 321105 0
Treatment: Other
Comparator / control treatment
Normal antenatal and postnatal care in three communities.

All sites will receive usual lactation support, including advice from midwives and Aboriginal Health Worker (AHW) in antenatal programs, advice from midwives, junior doctor and paediatricians in hospital maternity wards, and from lactation consultants based in hospitals. Other lactation support is provided by general practitioners (for example in Aboriginal medical services), child health nurses and community lactation consultants on demand or during routine postnatal checks and immunisation reviews. Some Aboriginal women also access private lactation consultants or access the Australian Breastfeeding Association (ABA) hotline as required.
Control group
Active

Outcomes
Primary outcome [1] 328193 0
(a) Exclusive breastfeeding at 6 weeks (24 hour recall - telephone or email) - Control vs Intervention
(statistical analysis will be performed on individual time points and across timepoints - combined)
Timepoint [1] 328193 0
(a) 6 weeks post-birth
Primary outcome [2] 332486 0
(b) Exclusive breastfeeding at 4 months (24 hour recall - telephone or email) - Control vs Intervention
Timepoint [2] 332486 0
b) at 4 months post-birth
Primary outcome [3] 332487 0
(c) Exclusive breastfeeding at 6 months (24 hour recall - telephone or email) - Control vs Intervention
Timepoint [3] 332487 0
(c) 6 months post-birth
Secondary outcome [1] 397986 0
Initiation of breastfeeding within first 24 hours (self – report at survey (telephone or email),


Timepoint [1] 397986 0
6 week post-birth survey



Secondary outcome [2] 406372 0
Days of exclusive breastfeeding (self-report from telephone or email survey)
Timepoint [2] 406372 0
6 week post-birth/4 month post-birth/6 month survey post-birth
Secondary outcome [3] 406373 0
Days of any breastfeeding. (self-report from telephone or email survey)
Timepoint [3] 406373 0
6 week post-birth/4 month post-birth/6 month survey post-birth
Secondary outcome [4] 406374 0
Age at introduction of expressed breastmilk (self-report)
Timepoint [4] 406374 0
6 week post-birth/4 month post-birth/6 month survey post-birth
Secondary outcome [5] 406375 0
Age of introduction of solid/semi-solid food (self-reported from telephone or email)
Timepoint [5] 406375 0
Collected at 6 week post-birth/4 month post-birth/6 month post-birth survey
Secondary outcome [6] 406376 0
Age at introduction of other breastmilk substitutes (self-report)
Timepoint [6] 406376 0
Collected at 6 week post-birth/4 month post-birth/6 month post-birth survey
Secondary outcome [7] 406377 0
Reason for cessation of breastfeeding including contraindications to breastfeeding (self-report)
Timepoint [7] 406377 0
Collected at 6 week post-birth/4 month post-birth/6 month post-birth survey
Secondary outcome [8] 406379 0
Hospitalisation in first 6 months of life
Timepoint [8] 406379 0
self–report at 6 months post-birth survey
Secondary outcome [9] 406380 0
Otitis media requiring antibiotics in first 6 months of life
Timepoint [9] 406380 0
self–report at 6 months post-birth survey
Secondary outcome [10] 406382 0
Breastfeeding at 12 months (self-reported from text message, email or phone call)
Timepoint [10] 406382 0
12 months post-birth
Secondary outcome [11] 413713 0
To identify barriers and facilitators for breastfeeding, sources of nutrition information, breastfeeding resources (pre-intervention; all sites) and to assess acceptability of the new peer support breastfeeding intervention (post-intervention; intervention sites only).
Timepoint [11] 413713 0
Yarns (one-on-one) to be completed pre- and post- intervention at all sites including five health professionals and five community members at each site.

Eligibility
Key inclusion criteria
Quantitative: Aboriginal or Torres Strait Islander women or non-Aboriginal women who have an Aboriginal or Torres Strait Islander infant that they are breastfeeding. Participants (mothers) will be over 14 years of age. Those who are aged 14-17 will need to obtain parental/guardian permission for involvement.

Qualitative:
a. Community members: participants, partners and aunties/grannies (10-15 before intervention and 10-15 after peer worker in place)
b. Service stakeholders: we plan to Yarn with Aboriginal Health Workers, child health nurses and midwives, general practitioners in ACCHS, ABA volunteers and lactation consultants. (10-15 before intervention and 10-15 after peer worker in place) as well as interviews with the 6 peer workers.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Quantitative:
Parents of Non-Aboriginal or Torres Strait Infants (that is neither parent is Aboriginal or Torres Strait Islander)
Girls younger than 14 years old will be excluded. Parental consent/permission will be obtained for girls aged 14-17 years old.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites will be stratified based on rurality and then randomised (either control or intervention) via simple cluster randomisation. Randomisation will stratify by the Modified Monash Model (MMM) – MM1 (major city) through to MM3 (large rural towns) using computer based program by biostatistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We plan to recruit a total of 720 participants (175 per arm), allowing for a 15% drop out, resulting in 612 participants for analyses at the end of 6 months. We plan to recruit 306 participants in group 1 (intervention) and 306 in group 2 (control), with three clusters in each group, with 102 subjects in each in group, resulting in 80.096% power to detect a difference between the group proportions of 0.1500. The proportion in group 1 (the treatment group) is assumed to be 0.2500 under the null hypothesis and 0.4000 under the alternative hypothesis. The proportion in group 2 (the control group) is 0.2500. The test statistic used is the two-sided Z-Test (Pooled), the intra-cluster correlation is 0.0100 and the significance level of the test is 0.050.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/07/2022
Date of last participant enrolment
Anticipated
27/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
720
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309085 0
Government body
Name [1] 309085 0
Medical Research Future Fund - Department of Health
Country [1] 309085 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Ave
Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 310051 0
None
Name [1] 310051 0
Address [1] 310051 0
Country [1] 310051 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308959 0
ISLHD/UOW Human Research Ethics Committee
Ethics committee address [1] 308959 0
Ethics committee country [1] 308959 0
Australia
Date submitted for ethics approval [1] 308959 0
19/07/2021
Approval date [1] 308959 0
21/10/2021
Ethics approval number [1] 308959 0
Ethics committee name [2] 308971 0
AHMRC Ethics Committee
Ethics committee address [2] 308971 0
Ethics committee country [2] 308971 0
Australia
Date submitted for ethics approval [2] 308971 0
19/11/2021
Approval date [2] 308971 0
11/01/2022
Ethics approval number [2] 308971 0

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

Contacts
Principal investigator
Name 112478 0
A/Prof Rowena Ivers
Address 112478 0
Graduate Medicine - Building 28
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 112478 0
Australia
Phone 112478 0
+61 242214341
Fax 112478 0
Email 112478 0
[email protected]
Contact person for public queries
Name 112479 0
Rebecca Thorne
Address 112479 0
Graduate Medicine - Building 28
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 112479 0
Australia
Phone 112479 0
+61 242215992
Fax 112479 0
Email 112479 0
[email protected]
Contact person for scientific queries
Name 112480 0
Rowena Ivers
Address 112480 0
Graduate Medicine - Building 28
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country 112480 0
Australia
Phone 112480 0
+61 242214341
Fax 112480 0
Email 112480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.