ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

ABFABB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

gestational weight management

Condition category

Condition code

Diet and Nutrition

Obesity

Reproductive Health and Childbirth

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]

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]

maternal weight

Timepoint [1]

first or second antenatal visit

Primary outcome [2]

BMI

Timepoint [2]

first or second antenatal visit

Secondary outcome [1]

consumption of soft drink

Timepoint [1]

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)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Canberra

Country [1]

Australia

Primary sponsor type

Government body

Name

NHMRC

Address

Canberra, ACT

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

https://www.wchn.sa.gov.au/research/human-research

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/10/2016

Approval date [1]

14/02/2017

Ethics approval number [1]

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

Prof Philippa Middleton

Address

SAHMRI, North Terrace, Adelaide, SA, 5000

Country

Australia

Phone

+61414747235

Fax

philippa.middleton@sahmri.com

Contact person for public queries

Name

Philippa Middleton

Address

SAHMRI, North Terrace, Adelaide, SA, 5000

Country

Australia

Phone

+61414747235

Fax

philippa.middleton@sahmri.com

Contact person for scientific queries

Name

Philippa Middleton

Address

SAHMRI, North Terrace, Adelaide, SA, 5000

Country

Australia

Phone

+61414747235

Fax

philippa.middleton@sahmri.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

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

Results publications and other study-related documents

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No additional documents have been identified.

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