Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001195347p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
10/09/2026
Date registered
Help: Date registered
25/09/2026
Date last updated
Help: Date last updated
25/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Co-designing a culturally tailored model of care for diabetes in pregnancy with Pacific communities
Scientific title
A Pasifika-led co-design study to develop a culturally tailored model of care for diabetes in pregnancy (DiP), using Talanga workshops with Pasifika women, whanau, and health professionals.
Additional trial identifiers [1] 318402 0
HRC 26/0337
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Diabetes in Pregnancy 343546 0
Gestational Diabetes 343646 0
Condition category
Condition code
Reproductive Health and Childbirth 339655 339655 0 0
Fetal medicine and complications of pregnancy
Metabolic and Endocrine 339656 339656 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This study uses a Pasifika-led co-design process to develop a culturally tailored model of care for diabetes in pregnancy (DiP), delivered through Talanga workshops.

A community co-design group will be formed, drawing on three participant streams: at least 10 Pasifika women who took part in Phase 1 interviews, at least 3 DiP health professionals. Families/whanau members contributed to the earlier Phase 1 focus groups but are not currently specified as direct participants in the Phase 2 co-design workshops.

Co-design will take place during Year 2 (Phase 2: Co-design Development) of the project, over a 12-month duration, through at least two interactive Talanga workshops, each approximately 3 to 4 hours long. Workshop 1 is anticipated to begin approximately 4 to 9 months after completion of Phase 1 data collection, once synthesis of Phase 1 findings is complete; the interval between Workshop 1 and Workshop 2 has not yet been fixed and will depend on the time needed for transcription, thematic analysis, and prototype development between sessions. Talanga is a Tongan participant-centred approach meaning "interactive talking with a purpose," enabling empowering and reciprocal dialogue toward shared decisions. Workshop 1 will appraise synthesised findings from Phase 1 and explore participants' wider experiences of DiP care, discussing existing challenges and brainstorming strength-based intervention opportunities. Between workshops, audio-recorded workshop data will be transcribed and analysed using a general inductive approach aligned with reflexive thematic analysis, and intervention prototypes will be drafted from the resulting themes. Workshop 2 will bring researchers, the Pasifika women and health professionals from the co-design group together to collaboratively finalise the intervention and agree a strategy for piloting it.

The co-design process will be guided by Associate Professor Malakai Ofanoa and Senior Research Fellow Dr Siobhan Tu'akoi, drawing on their experience facilitating co-design projects across gout, rheumatic fever, and maternal health in the Pacific region.

Workshops will take place in Auckland, in a venue agreed with participants (e.g. community hall, church, or university hub). Food and koha ($100 vouchers per workshop attended) will be provided, along with transport support where needed.

This phase does not test a health intervention; it develops one. The culturally tailored model of care produced through this co-design process will be described in full, and evaluated for feasibility and effectiveness, in a separate pilot testing study to be registered once the intervention's specific components are finalised.
Intervention code [1] 335299 0
Not applicable
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346826 0
Identifying challenges with current care practices for diabetes in pregnancy for Pasifika communties.
Timepoint [1] 346826 0
Completion of Workshop 1
Primary outcome [2] 346932 0
Identifying preferred care practices for diabetes in pregnancy for Pasifika communities
Timepoint [2] 346932 0
Completion of workshop 2
Secondary outcome [1] 467713 0
Participant engagement in the co-design workshops
Timepoint [1] 467713 0
Across Phase 2 (12 months, Co-design Development)

Eligibility
Key inclusion criteria
Pasifika women with diabetes in pregnancy who participated in Phase 1 interviews (any Pasifika ethnicity, including those identifying with more than one ethnicity); their family/whanau members; and health professionals involved in diabetes in pregnancy care in Auckland. All participants must be able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Individuals unable to provide informed consent; Pasifika women who did not participate in Phase 1 interviews

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
No formal sample size calculation was undertaken, as this is a qualitative, participatory co-design process rather than a hypothesis-testing study. Sample size (approximately 10 Pasifika women and 3 health professionals) was determined by feasibility and the scope of the co-design group established in Phase 1. Workshop data will be analysed using a general inductive approach aligned with reflexive thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2027
Actual
Date of last participant enrolment
Anticipated
31/07/2028
Actual
Date of last data collection
Anticipated
31/07/2028
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment outside Australia
Country [1] 28517 0
New Zealand
State/province [1] 28517 0
Auckland

Funding & Sponsors
Funding source category [1] 322977 0
Government body
Name [1] 322977 0
Health Research Council of New Zealand
Country [1] 322977 0
New Zealand
Primary sponsor type
University
Name
Waipapa Taumata Rau, The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 325907 0
None
Name [1] 325907 0
Address [1] 325907 0
Country [1] 325907 0
Other collaborator category [1] 284079 0
Government body
Name [1] 284079 0
Te Whatu Ora, Counties Manukau
Address [1] 284079 0
Country [1] 284079 0
New Zealand
Other collaborator category [2] 284103 0
Hospital
Name [2] 284103 0
Middlemore Hospital
Address [2] 284103 0
Country [2] 284103 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321388 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 321388 0
Ethics committee country [1] 321388 0
New Zealand
Date submitted for ethics approval [1] 321388 0
25/09/2026
Approval date [1] 321388 0
Ethics approval number [1] 321388 0

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

Contacts
Principal investigator
Name 153578 0
Dr Karaponi Okesene-Gafa
Address 153578 0
University of Auckland, Building 507, Level 3, Room 507-3070, 20-33 Park Road, Auckland 1023
Country 153578 0
New Zealand
Phone 153578 0
+64 21384471
Fax 153578 0
Email 153578 0
[email protected]
Contact person for public queries
Name 153579 0
Leila Rex
Address 153579 0
University of Auckland, Building 507, Level 3, 20-33 Park Road, Auckland 1023
Country 153579 0
New Zealand
Phone 153579 0
+64 21714213
Fax 153579 0
Email 153579 0
[email protected]
Contact person for scientific queries
Name 153580 0
Leila Rex
Address 153580 0
University of Auckland, Building 507, Level 3, 20-33 Park Road, Auckland 1023
Country 153580 0
New Zealand
Phone 153580 0
+64 21714213
Fax 153580 0
Email 153580 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: In accordance with the study's commitment to Pacific data sovereignty, individual participant data will not be made publicly available for reuse. De-identified data will be reported in aggregate form through peer-reviewed publications and this trial registry, but raw data will not be shared with third parties. Any future use of study data beyond this project would require separate ethical review and consultation with the Pacific advisory and co-design group.



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.