Deadly Fit Mums Exercise Program for Indigenous Mothers

Trial Review

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Registration number

ACTRN12626000522314 Ethics application status

Approved Date submitted

5/02/2026 Date registered

28/04/2026 Date last updated

28/04/2026 Date data sharing statement initially provided

28/04/2026 Type of registration

Retrospectively registered
Titles & IDs Public title A Community led exercise and nutrition program for mothers pregnant with Aboriginal and Torres Strait Islander babies Query! Scientific title Closing the final gaps in maternal and infant health: the Deadly Fit Mums program effectiveness study Query! Additional trial identifiers [1] 316419 0 2023264 Query! Universal Trial Number (UTN) U1111-1334-9981 Query! Trial acronym DFM (Deadly Fit Mum) Query! Related trial records Query!
Health condition Health condition(s) studied: pregnancy complications 340521 0 Query! premature birth 341280 0 Query! other complication at childbirth 341281 0 Query! Condition category Condition code Public Health 336718 336718 0 0 Query! Health service research Query!

Reproductive Health and Childbirth 336719 336719 0 0 Query! Antenatal care Query!

Reproductive Health and Childbirth 336720 336720 0 0 Query! Childbirth and postnatal care Query!

Reproductive Health and Childbirth 336721 336721 0 0 Query! Fetal medicine and complications of pregnancy Query!

Intervention/exposure Study type Interventional Query! Description of the intervention or exposure The elements that are unique to the Deadly Fit Mum (DFM) program are:

-A dedicated DFM Program Manager.

-Accredited Exercise Physiologist (AEP) available at each site (total four sites across South East Queensland).

-AEP supervised exercise sessions, delivered in line with clinical guidelines for exercising during pregnancy and the postpartum period, catering for all women, including those with a higher risk of and/or with established chronic conditions. More specifically:
1. one-hour exercise sessions offered once a week, with a flexible offering of the time of sessions available if the group identifies a need, to facilitate women’s availability to attend, over a minimum of 8 weeks with no maximum number of sessions per participants. Sessions attendance are recorded for each mum on an excel spreadsheet.
2. activity sessions are predominantly delivered in a group environment but can be or individually tailored one-to-one sessions for women with specific risks or needs, or for those preferring this method of access, as well as virtual sessions and home exercise programs offered upon request.
3. each session includes a varied intensity of different exercises, based on abilities, goals and interests of the women present on that day, which can be replicated at home with little to no equipment.
4. sessions delivered in a group environment start with education and yarning on expectations of the program, safe movement pre and post pregnancy, pelvic floor support and pelvic girdle support (kegels, pelvic tilts, gentle bridges, and squats), relaxing breathing techniques, lower back support (cat/cow stretches), safe lifting techniques, and abdominal strength support (side-lying leg lifts, seated belly breaths). On any given day, the Mums may choose to redirect the yarn towards a different topic of interest. The yarns are delivered in a supportive, group-led, non-judgmental way to allow Mums to contribute to or choose to sit back and listen to the topic at hand. The duration of the yarning is up to 30 minutes.

All women who register with the broader BiOC program are offered the opportunity to participate in DFM, it is the participants' choice to accept the offer.

Query! Intervention code [1] 333081 0 Lifestyle Query! Intervention code [2] 333438 0 Behaviour Query! Description of the comparator or control Mother-baby dyads participating in the Birthing in our Community program (BiOC)

Birthing in Our Community (BiOC) is an Aboriginal and Torres Strait Islander-designed and led maternity care and family support program initially established in 2013 in South Brisbane (QLD, Australia) by the Institute for Urban Indigenous Health (IUIH), together with its partner organisations, the Mater Mothers Hospital and the Aboriginal and Torres Strait Islander Community Health Service Brisbane (ATSICHS Brisbane, a member organisation of IUIH).

The BiOC program provide pregnant women with Aboriginal and Torres Strait Islanders babies access to a midwife, family support worker and multidisciplinary team for the duration of their pregnancy and birth and up to 2 months post-partum.

BiOC core elements include:

• Access to a birthing facility, specialist obstetric services, outreach (allied health) services, and social health services (social work, psychology, parenting support, support with child safety matters): – Intrapartum care is provided in the hospital birthing facility.
• A community-based hub to facilitate access to antenatal and postnatal care in a culturally safe environment: Parenting and cultural support are integrated into all elements of the services with the Community Hub offering a ‘no wrong door’ and ‘one stop shop’ approach to service delivery. Visiting and/or resident on-site services may include obstetric and gynecological services, sexual and reproductive health, adult Allied Health including physiotherapy, exercise physiology, dietician, and diabetes educator; psychosocial services including social worker, perinatal psychologist, and counselling services; and Paediatric medical, allied health and early childhood learning services.
• Continuity of Aboriginal and Torres Strait Islander Family Support Workers (FSW): the FSW works alongside the woman’s primary midwifery carer to connect, engage and retain families in the program, gather psychosocial information, identify strengths and needs, assist families to access required services and supports, and advocate, as requested, on behalf of families.
• Continuity of midwifery care including a known midwife during pregnancy (antenatal care), during birth and early parenting (postnatal care) for at least six weeks linked to the tertiary service with specialist support when needed. The midwives work between the community-based ACCHS-owned hub (for antenatal and postnatal care, education, and yarning groups), the Hospital (for birthing and specialist care), and the woman’s home (for antenatal and post-natal follow-up care as determined by the woman and her care team). Query! Control group Active Query! Outcomes Primary outcome [1] 344235 0 physical and socioemotional ATOMIC goals achieved over pregnancy - this will be assessed as a composite outcome Query! Timepoint [1] 344235 0 One assessment at each perinatal visit. The number of perinatal visits, thus the timepoints at which the ATOMIC-tool outcome will be measured variers between mums according to pregnancy stage and mums' needs but at least 7-10 perinatal visits are recommended over the duration of the pregnancy Query! Primary outcome [2] 344236 0 Emotional wellbeing Query! Timepoint [2] 344236 0 Once during pregnancy and at six weeks post pregnancy Query! Primary outcome [3] 344237 0 Gestational age at birth Query! Timepoint [3] 344237 0 at birth Query! Secondary outcome [1] 457208 0 Number of clinical antenatal visits during pregnancy. Query! Timepoint [1] 457208 0 once at the end of the pregnancy Query! Secondary outcome [2] 457209 0 Smoking before or after 20 weeks of pregnancy Query! Timepoint [2] 457209 0 Twice: before and after 20 weeks of pregnancy Query! Secondary outcome [3] 457342 0 Methods of birth (possible methos of birth are: spontaneous vaginal, assisted vaginal, emergency Caesarean-section, or elective Caesarean-section) Query! Timepoint [3] 457342 0 at childbirth Query! Secondary outcome [4] 457343 0 baby birthweight Query! Timepoint [4] 457343 0 At birth Query! Secondary outcome [5] 457344 0 Admissions to special and/or Intensive care nursery & length of stay - this will be assessed as a composite outcome Query! Timepoint [5] 457344 0 Once post delivery Query! Secondary outcome [6] 457345 0 Labour complication; perineal trauma (third-degree or fourth-degree tear, episiotomy), post-partum haemorrhage and blood loss amount, shoulder dystocia - this will be assessed as a composite outcome Query! Timepoint [6] 457345 0 Once at childbirth Query! Secondary outcome [7] 457346 0 Exclusively breastfeeding at hospital discharge Query! Timepoint [7] 457346 0 Once at hospital discharge Query! Secondary outcome [8] 457347 0 Hospital length of stay (mums). Query! Timepoint [8] 457347 0 Once at hospital discharge Query! Eligibility Key inclusion criteria All Pregnant and post-partum women will be eligible to participate if they identify as Aboriginal and/or Torres Strait Islander or are partnered to an Aboriginal and/or Torres Strait Islander person; receive maternity care through the Birthing in Own Community (BiOC) program; and consent to participate in the DFM program. Infants will be eligible if they are identified as Aboriginal and/or Torres Strait Islander and their mothers were recruited to any of the BiOC/DFM programs. Query! Minimum age 0 Years Query! Query! Maximum age No limit Query! Query! Sex Both males and females Query! Can healthy volunteers participate? No Query! Key exclusion criteria - women transferred in from outside the study hospitals (Brisbane Mater, Logan, Redland, Royal Women Hospital, Caboolture, Redcliff).
• women who receive care in the private hospital sector; and
• women who require guardianship for medical procedures. Query! Study design Purpose of the study Prevention Query! Allocation to intervention Non-randomised trial Query! Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Query! Methods used to generate the sequence in which subjects will be randomised (sequence generation) Query! Masking / blinding Open (masking not used) Query! Who is / are masked / blinded?

Query! Query! Query! Query! Intervention assignment Other Query! Other design features Two-arm non-randomized intervention study Query! Phase Not Applicable Query! Type of endpoint/s Query! Statistical methods / analysis Query!
Recruitment Recruitment status Active, not recruiting Query! Date of first participant enrolment Anticipated Query! Actual 1/01/2023 Query! Date of last participant enrolment Anticipated Query! Actual 30/06/2025 Query! Date of last data collection Anticipated 30/06/2026 Query! Actual Query! Sample size Target 1500 Query! Accrual to date Query! Final 1300 Query! Recruitment in Australia Recruitment state(s) QLD Query!
Funding & Sponsors Funding source category [1] 321024 0 Government body Query! Name [1] 321024 0 Department of Health, Disability and Ageing - Medical Research Future Fund (MRFF) Query! Country [1] 321024 0 Australia Query! Primary sponsor type Individual Query! Name Federica Barzi - University of Queensland Query! Address Query! Country Australia Query! Secondary sponsor category [1] 323732 0 None Query! Name [1] 323732 0 Query! Address [1] 323732 0 Query! Country [1] 323732 0 Query! Other collaborator category [1] 283874 0 Other Query! Name [1] 283874 0 Institute for Urban Indigenous Health Query! Address [1] 283874 0 Query! Country [1] 283874 0 Australia Query!
Ethics approval Ethics application status Approved Query! Ethics committee name [1] 319561 0 The University of Queensland Human Research Ethics Committee A Query! Ethics committee address [1] 319561 0 https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics Query! Ethics committee country [1] 319561 0 Australia Query! Date submitted for ethics approval [1] 319561 0 06/05/2025 Query! Approval date [1] 319561 0 18/06/2025 Query! Ethics approval number [1] 319561 0 2025/HE000966 Query!
Summary Brief summary The Deadly Fit Mums (DFM) is an Aboriginal community-led program delivered in greater Brisbane. It is an exercise and nutrition education program offered perinatally to women birthing an Aboriginal and Torres Strait Islander baby through the Birthing into Our Community program. DFM is led by an accredited exercise physiologist and delivered in partnership with a multidisciplinary team of allied health professionals. We anticipate that participation in the DFM program will lead to an improvement in Maternal and Infant health outcomes. Query! Trial website Query! Trial related presentations / publications Query! Public notes Ethics approval was not attained prior to recruitment of the first participant for administrative issues and delays in the application, Query!
Contacts Principal investigator Name 147714 0 A/Prof Federica Barzi Query! Address 147714 0 University of Queensland Poche Centre for Indigenous Health, 74 High St, Toowong QLD 4066 Query! Country 147714 0 Australia Query! Phone 147714 0 +61 415 767632 Query! Fax 147714 0 Query! Email 147714 0 [email protected] Query! Contact person for public queries Name 147715 0 Federica Barzi Query! Address 147715 0 University of Queensland Poche Centre for Indigenous Health, 74 High St, Toowong QLD 4066 Query! Country 147715 0 Australia Query! Phone 147715 0 +61 415 767632 Query! Fax 147715 0 Query! Email 147715 0 [email protected] Query! Contact person for scientific queries Name 147716 0 Federica Barzi Query! Address 147716 0 University of Queensland Poche Centre for Indigenous Health, 74 High St, Toowong QLD 4066 Query! Country 147716 0 Australia Query! Phone 147716 0 +61 415 767632 Query! Fax 147716 0 Query! Email 147716 0 [email protected] Query!
Data sharing statement Will the study consider sharing individual participant data? No
No IPD sharing reason/comment: This project include sensitive information and data of Aboriginal and Torres Strait Isander Peoples. The Institute for Urban Indigenous Health is the data custodian, For these reasons it will not be possible to share individual participant data.

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Results publications and other study-related documents

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