Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000683538
Ethics application status
Approved
Date submitted
18/01/2024
Date registered
29/05/2024
Date last updated
29/05/2024
Date data sharing statement initially provided
29/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of the Aboriginal Family and Baby Bundles (ABFABB) program
Scientific title
Effect of a culturally appropriate healthy eating strategy on maternal weight; maternal nutrition; breastfeeding practices; infant health and growth
Secondary ID [1] 311940 0
None
Universal Trial Number (UTN)
Trial acronym
ABFABB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gestational weight management 332630 0
Condition category
Condition code
Diet and Nutrition 329334 329334 0 0
Obesity
Reproductive Health and Childbirth 329588 329588 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Aboriginal Family and Baby Bundles (ABFABB) program provided by ABFABB staff to Aboriginal Women and their children; and Aboriginal children with a non-Aboriginal mother, participating in the Aboriginal Family Birthing Program at the Women's and Children's Hospital, North Adelaide, South Australia.
The ABFABB program consisted of 8 baby bundles provided to participants at particular stages of the gestation/perinatal periods:
Study-specific written advice about breastfeeding was provided at 30-32 weeks gestation and when the infant was 4-5 months (e.g. weaning advice)
i) <15 weeks gestation; fresh food (2 kilos vegetables; 2 kilos fruit; 1 kilo meat (lamb, chicken or beef); 500 ml oil; or food vouchers ($100); a tote bag with Indigenous design
ii) 18-20 weeks gestation: glucose test at clinic; fresh food (2 kilos vegetables; 2 kilos fruit; 500 ml oil; 1 kilo meat (lamb, chicken or beef); or food vouchers ($100); a tote bag with Indigenous design
iii) 30-32 weeks gestation: written advice about breastfeeding; breast pumps; fresh food (2 kilos vegetables; 2 kilos fruit; 500 ml oil; 1 kilo meat (lamb, chicken, beef); or food vouchers ($100)
iv) Birth: fresh food (2 kilos vegetables; 2 kilos fruit; 1 kilo meat (lamb, chicken or beef) or food vouchers ($100); baby clothes/items (1 onesie; 1 breastfeeding wrap with Indigenous design)
v) 1-4 weeks: baby check up with child and family nurses; fresh food (2 kilos vegetables; 2 kilos fruit; 1 kilo meat (lamb, chicken or beef) or food vouchers ($100);
vi) infant 4-5 months: written and verbal advice on infant feeding and transition to solids; fresh food (2 kilos vegetables; 2 kilos fruit; 1 kilo meat (lamb, chicken or beef); or food vouchers ($100)
vii) infant 8 months: fresh food (2 kilos vegetables; 2 kilos fruit; 1 kilo meat (lamb, chicken or beef); or food vouchers ($100); books for baby
viii) infant 12 months: fresh food (2 kilos vegetables; 2 kilos fruit; 1 kilo meat (lamb, chicken or beef); or food vouchers ($100)
Participants were asked to complete or provide the following: questionnaires (e.g. dietary patterns), weighing; blood samples (only if women agreed), antenatal clinic attendance; child and family clinic attendance; completion of questionnaires regarding diet and exercise; 'baby bundles' - consisting of advice, food deliveries to home; food preparation items; breast pumps; books for baby; water bottles; print resources (e.g. healthy recipes)
e) baby bundles from early pregnancy to first year postpartum (during pandemic restrictions, postpartum items (especially food deliveries) were delivered to participants' homes (initially at Women's and Children's Hospital, then home delivery/visits (again due pandemic restrictions))
Research staff interacting with participants were all Aboriginal women; also a group of Aboriginal people advised the program; including advice on content of bundles; and respectful approaches to participants
Pandemic restrictions meant that we sometimes had to rearrange timings and/or supply several bundles at once.
Intervention code [1] 328672 0
Prevention
Comparator / control treatment
No contemporaneous control, However we compared outcomes from ABFABB with Aboriginal and/or Torres Strait Islander women attending antenatal care at the same facility (Women's and Children's Hospital, SA) in the 12 months prior to commencement of the ABFABB study.
Control group
Historical

Outcomes
Primary outcome [1] 338075 0
maternal weight
Timepoint [1] 338075 0
first or second antenatal visit
Primary outcome [2] 338361 0
BMI
Timepoint [2] 338361 0
first or second antenatal visit
Secondary outcome [1] 434392 0
consumption of soft drink
Timepoint [1] 434392 0
first or second antenatal visit

Eligibility
Key inclusion criteria
Aboriginal and/or Torres Strait Islander women who were pregnant (and intending to give birth at the Women's and Children's Hospital, Adelaide, South Australia) and their infants.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Transfer from Women and Children's Hospital

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Pandemic disruptions meant that we were not able to recruit or contact participants in the hospital, and we also drastically cut back on home visits
Date of first participant enrolment
Anticipated
Actual
22/06/2017
Date of last participant enrolment
Anticipated
Actual
24/03/2022
Date of last data collection
Anticipated
Actual
1/12/2023
Sample size
Target
300
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315623 0
Government body
Name [1] 315623 0
NHMRC
Country [1] 315623 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Canberra, ACT
Country
Australia
Secondary sponsor category [1] 317716 0
None
Name [1] 317716 0
Address [1] 317716 0
Country [1] 317716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314506 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 314506 0
https://www.wchn.sa.gov.au/research/human-research
Ethics committee country [1] 314506 0
Australia
Date submitted for ethics approval [1] 314506 0
19/10/2016
Approval date [1] 314506 0
14/02/2017
Ethics approval number [1] 314506 0

Summary
Brief summary
Population: Women giving birth to Aboriginal children participating in the Aboriginal Family Birthing Program (AFBP) at the Women’s and Children’s Hospital (WCH), Adelaide and through Child and Family Health Centres (CaFHS), SA.
Study design: Mixed methods: qualitative (consultations with young Aboriginal women, community members and service providers), and continuous quality improvement (Plan-Do-Study-Act (PDSA) cycles) involving nutritional support and health literacy.
Interventions: Culturally appropriate, intensive multifaceted intervention strategy to promote healthy eating embedded in SA AFBP/CaFHS, centering around 9 ‘mother and baby bundles’ given to participating families by Aboriginal Maternal and Infant care workers and CaFHS staff at key points in pregnancy and the first 12 months postpartum, refined through PDSA cycles.
Comparisons: Routine data from past AFBP clients and their babies.
Outcomes: Increase in proportion of women with healthy gestational weight gain and healthy postpartum weight, improved dietary changes (e.g. increased vegetable consumption), increased engagement and satisfaction with the program, improved nutritional status, higher rates of breastfeeding and improved infant health and growth.
Significance: This intervention strategy will identify effective and sustainable ways to engage young women (and partners/children) in making healthy food choices, in managing weight, and in reducing obesity and associated short, long-term and intergenerational issues.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131826 0
Prof Philippa Middleton
Address 131826 0
SAHMRI, North Terrace, Adelaide, SA, 5000
Country 131826 0
Australia
Phone 131826 0
+61414747235
Fax 131826 0
Email 131826 0
philippa.middleton@sahmri.com
Contact person for public queries
Name 131827 0
Prof Philippa Middleton
Address 131827 0
SAHMRI, North Terrace, Adelaide, SA, 5000
Country 131827 0
Australia
Phone 131827 0
+61414747235
Fax 131827 0
Email 131827 0
philippa.middleton@sahmri.com
Contact person for scientific queries
Name 131828 0
Prof Philippa Middleton
Address 131828 0
SAHMRI, North Terrace, Adelaide, SA, 5000
Country 131828 0
Australia
Phone 131828 0
+61414747235
Fax 131828 0
Email 131828 0
philippa.middleton@sahmri.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21440Study protocol  philippa.middleton@sahmri.com
21441Ethical approval  philippa.middleton@sahmri.com
21442Informed consent form  philippa.middleton@sahmri.com
21443Clinical study report  philippa.middleton@sahmri.com



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.