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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001160325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
12/08/2026
Date registered
Help: Date registered
17/09/2026
Date last updated
Help: Date last updated
17/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/09/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Feasibility and acceptability of a co-created family-centred self-management program for Aboriginal women with diabetes in pregnancy: a pilot study
Scientific title
Feasibility and acceptability of a co-created family-centred self-management program for Aboriginal women with hyperglycaemia in pregnancy: a pilot study
Additional trial identifiers [1] 317485 0
MRFMB000045
Additional trial identifiers [2] 317910 0
2021_GR001280
Universal Trial Number (UTN)
Trial acronym
ORCHID
Related trial records

Health condition
Health condition(s) studied:
Diabetes in pregnancy 342180 0
Diabetes 343296 0
Condition category
Condition code
Reproductive Health and Childbirth 338309 338309 0 0
Antenatal care
Metabolic and Endocrine 338310 338310 0 0
Diabetes
Reproductive Health and Childbirth 338311 338311 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Women with any form of hyperglycaemia in pregnancy inclusive of type 1 diabetes, type 2 diabetes and gestational diabetes during pregnancy and up to 6-months post-pregnancy. Observation of standard care.

Co-creation process: The framework for the ORCHID program was co-designed in 2023-2025. The ORCHID working group, including four Aboriginal researchers, conducted research yarns and semi-structured interviews with 49 Aboriginal women with gestational diabetes, their family members and healthcare providers from the Kimberley, South West and Great Southern regions of Western Australia.

Key themes within ten topics were identified by the ORCHID working group. Findings from the research yarns and interviews were shared with 28 co-investigators during eight workshops in Broome and Bunbury. Co-investigators included: 21 Aboriginal community members including women and their partners who recently had a baby, six healthcare providers and one ACCHO board member. Each workshop ran for two to three days. Co-investigators discussed the findings and developed a set of recommendations that informed a program framework. The framework has informed the co-design of an implementation manual for the pilot program at each site: South West Aboriginal Medical Service (SWAMS) and Broome Regional Aboriginal Medical Service (BRAMS).

The pilot program will be delivered as part of standard care, throughout antenatal care and postpartum up to 6 months. It will be conducted at both sites for 24 months and there will be no limit to the number of times a family can engage in the program.

The manual for each site will include:
- Each of the program components:
*Professional development and training for staff for community mentors.
o Offering early HbA1c testing (at first antenatal visit <20 weeks gestation)
o Offering HbA1c testing between 4 and 6 months postpartum to coincide with child health checks (for all postpartum women and support people)
o Assigning Aboriginal Health Navigator at each site to assist in continuity of care and perform barrier reducing tasks (identified during the pilot period) during antenatal and post-partum periods.
o Offering Continuous Glucose Monitors to monitor blood glucose levels
o Offering peer mentor support to families
o Offering digital and hardcopy resources to families, identified during the co-design process
o Offering components one on one and in groups; online and face-to-face, depending upon participant preferences.
- Roles and responsibilities:
Program delivery at each site will be championed by;
o The lead midwife during the antenatal period.
o The lead child health nurse in the Maternal Child Health team and the Chronic Conditions team lead for the postpartum period.
o The Aboriginal Health Navigator will oversee day to day activities and ensure continuity of care throughout the patient journey.
- The evaluation plan:
o Acceptability and feasibility will be assessed using measures co-designed with each site, through surveys, semi-structured interviews and research yarns with consenting healthcare providers and family members.
o The program will evolve over time based on acceptability and feasibility at each of the pilot sites and all changes will be documented in each of the manuals.

*Training for the Aboriginal Health Navigator has been co-designed with each site and includes standard on-boarding procedures. External training delivered by DiabetesWA (Diabetes Education Self-management Yarning DESY, 37.5 hours training prior to engagement with families). Other training identified by the Navigator and the services will be integrated as required.
Intervention code [1] 334756 0
Not applicable
Description of the comparator or control
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345648 0
Feasibility of implementing the co-created family-centred self-management program for Aboriginal women with diabetes in pregnancy at two pilot sites.
Timepoint [1] 345648 0
Quarterly for aggregated EMR reports until 6 months after the end of the 24-month pilot. Ad hoc for CQI check-in at time points determined by each pilot site during the 24-month pilot. Currently fortnightly but may change as required. Annual review for feasibility of training staff until 6 months after the end of the 24-month pilot.
Primary outcome [2] 346206 0
Acceptability of the co-created family-centred self-management program for program participants.
Timepoint [2] 346206 0
Program participants: Timepoint 1: Early pregnancy (before 24 weeks gestation); Timepoint 2: late pregnancy (from 24 weeks gestation); and Timepoint 3: between delivery and 6-months post program participation. Participants who provide informed consent will be invited to participate in a maximum of three interviews (one per timepoint); and to participate in a maximum of three questionnaires (one per timepoint).
Primary outcome [3] 346703 0
Acceptability of the co-created family-centred self-management program for healthcare providers.
Timepoint [3] 346703 0
Healthcare providers: throughout program from the start of the pilot until 6 months after the end of the pilot. Timing, frequency and format of interviews and questionnaires will be determined in consultation with the health services.
Secondary outcome [1] 464998 0
Engagement with continuous glucose monitoring
Timepoint [1] 464998 0
Quarterly from the start of the pilot until 6 months after the end of the pilot.

Eligibility
Key inclusion criteria
Program participants: Women with diabetes in pregnancy carrying Aboriginal babies, and their family members, accessing South West Aboriginal Medical Service (SWAMS) or Broome Regional Aboriginal Medical Service (BRAMS) for antenatal care.

Healthcare providers: anyone involved in providing care to program participants, including the Aboriginal Health Navigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
No key exclusion criteria as pilot sites will offer the program to all eligible women and their families as part of standard care.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics for quantitative data. Thematic analysis of qualitative data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2026
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
31/07/2028
Actual
Sample size
Target
100
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 321324 0
Government body
Name [1] 321324 0
Australian Government Department of Health (Medical Research Futures Fund)
Country [1] 321324 0
Australia
Funding source category [2] 322446 0
Government body
Name [2] 322446 0
Western Australian Department of Health (Future Health Research and Innovation Fund)
Country [2] 322446 0
Australia
Funding source category [3] 322700 0
University
Name [3] 322700 0
The Rural Clinical School of WA
Country [3] 322700 0
Australia
Funding source category [4] 322701 0
Other
Name [4] 322701 0
Kimberley Aboriginal Medical Services
Country [4] 322701 0
Australia
Funding source category [5] 322702 0
Charities/Societies/Foundations
Name [5] 322702 0
Diabetes WA
Country [5] 322702 0
Australia
Funding source category [6] 322703 0
Other
Name [6] 322703 0
South West Aboriginal Medical Service
Country [6] 322703 0
Australia
Funding source category [7] 322704 0
Other
Name [7] 322704 0
Broome Regional Aboriginal Medical Services
Country [7] 322704 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 325372 0
None
Name [1] 325372 0
Address [1] 325372 0
Country [1] 325372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319857 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 319857 0
Ethics committee country [1] 319857 0
Australia
Date submitted for ethics approval [1] 319857 0
16/07/2014
Approval date [1] 319857 0
16/09/2014
Ethics approval number [1] 319857 0
584
Ethics committee name [2] 320938 0
Department of Health WA Human Research Ethics Committee
Ethics committee address [2] 320938 0
Ethics committee country [2] 320938 0
Australia
Date submitted for ethics approval [2] 320938 0
29/01/2024
Approval date [2] 320938 0
07/03/2024
Ethics approval number [2] 320938 0

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

Contacts
Principal investigator
Name 148634 0
Prof Julia Marley
Address 148634 0
Rural Clincial School of WA (Broome), 12 Napier Terrace, Broome WA 6725
Country 148634 0
Australia
Phone 148634 0
+61 8 9194 3235
Fax 148634 0
Email 148634 0
[email protected]
Contact person for public queries
Name 148635 0
Kylie Bowden
Address 148635 0
Rural Clincial School of WA (Albany), 31 Stirling Terrace, Albany WA 6330
Country 148635 0
Australia
Phone 148635 0
+61 8 9842 0849
Fax 148635 0
Email 148635 0
[email protected]
Contact person for scientific queries
Name 148636 0
Emma Jamieson
Address 148636 0
Rural Clincial School of WA (Bunbury), Building 3 ECU South West Campus, Robertson Drive,Bunbury WA 6230
Country 148636 0
Australia
Phone 148636 0
+61 8 9722 0510
Fax 148636 0
Email 148636 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



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.