Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000850572
Ethics application status
Approved
Date submitted
5/06/2024
Date registered
9/07/2024
Date last updated
9/07/2024
Date data sharing statement initially provided
9/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation and evaluation of co-designed strategies with Aboriginal and Torres Strait Islander women aiming to reduce diabetes-related risks before, during and after pregnancy
Scientific title
Evaluation of implementation to support healthy lifestyles for Aboriginal and Torres Strait Islander women with diabetes in pregnancy (Part C)
Secondary ID [1] 312237 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes in pregnancy (including gestational diabetes, overt diabetes in pregnancy and pre-existing diabetes) 333941 0
Obesity 333942 0
Condition category
Condition code
Metabolic and Endocrine 330612 330612 0 0
Diabetes
Public Health 330613 330613 0 0
Health promotion/education
Reproductive Health and Childbirth 330614 330614 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 330615 330615 0 0
Antenatal care
Reproductive Health and Childbirth 330616 330616 0 0
Breast feeding
Reproductive Health and Childbirth 330617 330617 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 330618 330618 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 330904 330904 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multi-component program co-designed with Aboriginal and Torres Strait Islander women, communities and health services, conducted across three sites.

Intervention components include:
1. Face-to-face group health education sessions with women, facilitated by an Aboriginal or Torres Strait Islander woman with a guest 'expert' relevant to the topic. Topics are tailored to each study site, having been nominated by co-design participants in the formative phase of this study, and include topics relating to diabetes (what is diabetes, managing diabetes, preventing diabetes, understanding intergenerational diabetes), healthy eating, pregnancy planning and contraception, healthy infant feeding, postpartum support, sexual health, and social and emotional wellbeing. Group education sessions will be delivered in a community space (i.e. not in a clinical setting), with the specific space being determined by stakeholders in each site. Education sessions in each region will occur monthly for 2-3 hours. Facilitators will have all completed a culturally appropriate short course in facilitation either prior to or in the early phase of implementation. Attendance logs will be kept, and session facilitators will debrief after sessions to discuss how the session was run, including adherence to pre-planned session goals and structure.

2. Supporting community members to produce locally-made videos to share health promotion messages relating to diabetes in pregnancy in local languages. Research staff will provide support to produce short (less than 3 minute) live action videos. Health promotion messages, languages and dissemination strategies will be determined by video participants, although based on formative work it is anticipated dissemination will include through social media.

3. Advocacy with communities and in partnership with other key stakeholders regarding food security; specific components of this will be determined by an action group of community and agency stakeholders brought together within the first month of implementation, and may include:
a. The facilitating of the action group itself, comprising community and agency stakeholders
b. Development or distribution of existing health promotion materials and promoting these through a community campaign, e.g. review of existing health promotion materials by action group members and study staff; identification of gaps where development of new resources may be required; identification of contextually appropriate dissemination methods and support from study staff and action group members to implement these
c. Working with stores to maximise the potential of store as health promoting environments, e.g. modifications to product placement and pricing, sales promotions on healthy foods and water

4. Enhancing the knowledge and confidence of healthcare professionals to support women with diabetes in pregnancy by providing information, research updates and networking opportunities, such as through the :
a. Diabetes in Pregnancy Clinical Reference Group (quarterly online meetings) - one hour meeting providing updates of recent contextually relevant research findings, feedback from reference group members regarding relevance of findings to clinical practice and policies, and input from reference group members regarding any additional concerns/priority areas which could be addressed through research/quality improvement projects
b. Dissemination of policy and practice briefs (twice per year, distributed by email) to health services and clinicians across the Northern Territory and Far North Queensland, including summaries of relevant research findings and implications for policy and practice
c. Annual Diabetes Across the Lifecourse; Northern Australia Partnership Educational Symposium (in-person and online) - full-day educational meeting with multiple presentations from local and national/international guest speakers on topics relevant to diabetes care, with dedicated time for networking and interactive component for attendees to discuss relevance of presentations to practice
Attendance lists, dissemination logs and minutes will be reviewed to monitor adherence

5. Improving access to physical activity through monthly water fitness activities, e.g. aquarobics, facilitated by an experienced physiotherapist with plan to build the capacity of local community members to continue delivery of the physical activity program through training interested local members to be facilitators

Intervention components will be delivered over a 12 months period. The specific components implemented in each site are determined by co-design participants, i.e. it is anticipated that not all components will be implemented in every site. Implementation of program components will be conducted in each region as a collaboration between study staff and staff of partner organisations such as the participating Aboriginal Community Controlled Health Service. Implementation and evaluation of activities in each region will be supported by a working group, comprising study staff, Aboriginal and Torres Strait Islander women and representatives from local stakeholder organisations.
Intervention code [1] 328761 0
Prevention
Intervention code [2] 328762 0
Lifestyle
Intervention code [3] 328763 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338455 0
Impact on individual measures of participant metabolic health and wellbeing - HbA1c
Timepoint [1] 338455 0
Baseline, 6 and 12 months (primary timepoint) after baseline assessment
Primary outcome [2] 338456 0
Impact on individual measures of participant metabolic health and wellbeing - urine albumin-creatinine ratio
Timepoint [2] 338456 0
Baseline, 6 and 12 months (primary timepoint) after baseline assessment
Primary outcome [3] 338457 0
Impact on individual measures of participant metabolic health and wellbeing - blood lipid profile
Timepoint [3] 338457 0
Baseline, 6 and 12 months (primary timepoint) after baseline assessment
Secondary outcome [1] 436017 0
Impact on individual measures of participant metabolic health and wellbeing - weight
Timepoint [1] 436017 0
Baseline, 6 and 12 months after baseline
Secondary outcome [2] 436018 0
Impact on individual measures of participant metabolic health and wellbeing - waist circumference
Timepoint [2] 436018 0
Baseline, 6 and 12 months after baseline
Secondary outcome [3] 436019 0
Impact on individual measures of participant metabolic health and wellbeing - waist/hip ratio
Timepoint [3] 436019 0
Baseline, 6 and 12 months after baseline
Secondary outcome [4] 436020 0
Impact on individual measures of participant metabolic health and wellbeing - body mass index
Timepoint [4] 436020 0
baseline, 6 and 12 months after baseline
Secondary outcome [5] 436021 0
Impact on individual measures of participant metabolic health and wellbeing - dietary intake/diet quality
Timepoint [5] 436021 0
Baseline, 6 and 12 months after baseline
Secondary outcome [6] 436022 0
Impact on individual measures of participant metabolic health and wellbeing - dietary intake/diet quality
Timepoint [6] 436022 0
Baseline, 6 and 12 months after baseline
Secondary outcome [7] 436023 0
Impact on individual measures of participant metabolic health and wellbeing - physical activity
Timepoint [7] 436023 0
Baseline, 6 and 12 months after baseline
Secondary outcome [8] 436024 0
Impact on individual measures of participant metabolic health and wellbeing - medication adherence
Timepoint [8] 436024 0
Baseline, 6 and 12 months after baseline
Secondary outcome [9] 436025 0
Impact on individual measures of participant metabolic health and wellbeing - knowledge of diabetes and ability to self-manage diabetes (composite outcome)
Timepoint [9] 436025 0
Baseline, 6 and 12 months after baseline
Secondary outcome [10] 436026 0
Impact on individual measures of participant metabolic health and wellbeing - knowledge of available supports/services
Timepoint [10] 436026 0
Baseline, 6 and 12 months after baseline
Secondary outcome [11] 436027 0
Impact on individual measures of participant metabolic health and wellbeing - health service utilisation
Timepoint [11] 436027 0
Baseline, 6 and 12 months after baseline
Secondary outcome [12] 436028 0
Impact on individual measures of participant metabolic health and wellbeing - social and emotional wellbeing
Timepoint [12] 436028 0
Baseline, 6 and 12 months after baseline
Secondary outcome [13] 436029 0
Impact on individual measures of participant metabolic health and wellbeing - social and emotional wellbeing
Timepoint [13] 436029 0
Baseline, 6 and 12 months after baseline
Secondary outcome [14] 436030 0
Impact on individual measures of participant metabolic health and wellbeing - cultural connectedness
Timepoint [14] 436030 0
Baseline, 6 and 12 months after baseline
Secondary outcome [15] 436031 0
Impact of the program on sites (communities and health services) as health promoting environments - clinician knowledge and confidence in managing health relating to risks before, during and after a pregnancy complicated by diabetes
Timepoint [15] 436031 0
Baseline, 6 and 12 months after baseline
Secondary outcome [16] 436032 0
Impact of the program on sites (communities and health services) as health promoting environments - changes in community capacity such as knowledge of the issues, community climate, leadership, and resourcing
Timepoint [16] 436032 0
Baseline, 6 and 12 months after baseline
Secondary outcome [17] 436033 0
Determine the acceptability of the implementation of the evidence-based, co-designed strategies at the study sites - participation rates
Timepoint [17] 436033 0
6 and 12 months after commencement
Secondary outcome [18] 436034 0
Determine the sustainability of the implementation of the evidence-based, co-designed strategies at the study sites
Timepoint [18] 436034 0
12 months after commencement of implementation
Secondary outcome [19] 436035 0
To identify the enablers and barriers to implementation
Timepoint [19] 436035 0
6 and 12 months after commencement of implementation
Secondary outcome [20] 436980 0
Determine the acceptability of the implementation of the evidence-based, co-designed strategies at the study sites - participation rates
Timepoint [20] 436980 0
6 and 12 months after commencement
Secondary outcome [21] 436981 0
Determine the acceptability of the implementation of the evidence-based, co-designed strategies at the study sites - factors influencing participation
Timepoint [21] 436981 0
6 and 12 months after commencement
Secondary outcome [22] 436982 0
Determine the acceptability of the implementation of the evidence-based, co-designed strategies at the study sites - attendance rate of participants
Timepoint [22] 436982 0
6 and 12 months after commencement

Eligibility
Key inclusion criteria
Three participant groups:

1. Aboriginal and Torres Strait Islander women between 16-45 years of age who have had an experience of diabetes in pregnancy - defined as All Aboriginal and Torres Strait Islander women who are between the ages of 16-45 and who have connections with the study site (i.e. living in the community, and/or who have received health care at the community’s clinic) and who have an experience of diabetes in pregnancy (any type of diabetes and at any point during the woman’s life)
2. Aboriginal and Torres Strait Islander community members above the age of 16 including family members - defined as community members residing in the study sites and who are over the age of 16
3. Health professionals, health stakeholders, community stakeholders (councils, NGOs), researchers and advocates - defined as either members of the health workforce or community services (clinic, NGOs, councils) who are interested in diabetes prevention/management (all over the age of 16) OR those involved in supporting implementation of system-wide components (i.e. policy makers, clinical champions, health service managers).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Unable to provide informed consent
* Under the age of 16 years

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/02/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
150
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD

Funding & Sponsors
Funding source category [1] 316615 0
Government body
Name [1] 316615 0
Medical Research Future Fund - Department of Health and Ageing
Country [1] 316615 0
Australia
Funding source category [2] 316687 0
Other Collaborative groups
Name [2] 316687 0
Centre of Research Excellence Health in Preconception & Pregnancy
Country [2] 316687 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
Country
Australia
Secondary sponsor category [1] 318879 0
None
Name [1] 318879 0
Address [1] 318879 0
Country [1] 318879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315400 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 315400 0
Ethics committee country [1] 315400 0
Australia
Date submitted for ethics approval [1] 315400 0
01/03/2023
Approval date [1] 315400 0
27/04/2023
Ethics approval number [1] 315400 0
2023-4551

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

Contacts
Principal investigator
Name 134582 0
Prof Louise Maple-Brown
Address 134582 0
Menzies School of Health Research, JMB 105 Rocklands Drive, Tiwi, NT, 0810
Country 134582 0
Australia
Phone 134582 0
+61 416 163 814
Fax 134582 0
Email 134582 0
[email protected]
Contact person for public queries
Name 134583 0
Tara Dias
Address 134583 0
Menzies School of Health Research, JMB 105 Rocklands Drive, Tiwi, NT, 0810
Country 134583 0
Australia
Phone 134583 0
+61 08 8946 8528
Fax 134583 0
Email 134583 0
[email protected]
Contact person for scientific queries
Name 134584 0
Diana MacKay
Address 134584 0
Menzies School of Health Research, JMB 105 Rocklands Drive, Tiwi, NT, 0810
Country 134584 0
Australia
Phone 134584 0
+61 08 8922 8888
Fax 134584 0
Email 134584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unable to share due to sensitive nature of the data


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.