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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06896292




Registration number
NCT06896292
Ethics application status
Date submitted
13/03/2025
Date registered
26/03/2025

Titles & IDs
Public title
Testing a Digital Tool to Support Healthy Pregnancies
Scientific title
Efficacy, Feasibility, and Acceptability of a Hybrid Patient Care Model in Improving Access to Guideline Recommended Antenatal Preventive Care
Secondary ID [1] 0 0
2025/ETH00079
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventive Behaviors 0 0
Antenatal Care and Delivery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Hybrid care model
Other interventions - Usual Care

Experimental: Hybrid care model - The Hybrid care model will involve guideline-recommended preventive care (AAH) for smoking, nutrition, alcohol, physical activity and gestational weight gain- standard care as it is currently delivered within antenatal appointments conducted by maternity services + use of a digital support tool. The digital tool will allow patients to undertake self-assessment of smoking, nutrition, alcohol, physical activity and gestational weight gain risks, receive information and make self-referrals to support services at a time and in a way that suits them. Self-assessment results and information on self-referrals will be provided to antenatal clinicians prior to appointments to support clinician follow-up. The provision of preventive care via the digital support tool will facilitate more streamlined appointments by addressing priority issues and freeing up appointment time to address issues most relevant to the participant.

Active comparator: Usual care model - Usual guideline-recommended preventive care (AAH) for smoking, nutrition, alcohol, physical activity and gestational weight gain- standard care as it is currently delivered within antenatal appointments conducted by maternity services


BEHAVIORAL: Hybrid care model
Participants will receive usual antenatal care (in-person), plus the digital support tool. A co-design process was used to develop the tool based on consumer feedback.

The tool is based on the recommended Assess/ask, Advise, Help approach to preventive care for smoking, nutrition, alcohol, physical activity and gestational weight gain.

Participants will be prompted (via SMS) to use the digital support tool at regular intervals throughout their pregnancy to self-assess health risks and be reminded of recommendations and available coaching services.

Other interventions: Usual Care
Participants will receive usual antenatal care (in-person), which is recommended to include the delivery of preventive care using the AAH model for smoking, nutrition, alcohol, physical activity and gestational weight gain.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Receipt of preventive care (Assessment of health risks)
Timepoint [1] 0 0
Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.
Primary outcome [2] 0 0
Receipt of preventive care (Advice about health risks)
Timepoint [2] 0 0
Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.
Primary outcome [3] 0 0
Receipt of preventive care (Help to address health risks)
Timepoint [3] 0 0
Throughout study via digital tool analytics and during interviews conducted approximately 1-3 weeks following three antenatal appointments, that is, the first appointment (14-20 weeks), 28-week and 36-week gestation appointment.

Eligibility
Key inclusion criteria
* Any pregnant person (aged 18 years and over) with a scheduled first antenatal appointment at one of the two participating maternity services
* Sufficient level of English language proficiency to access and use the digital support tool and complete follow-up surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any pregnant person who has had an adverse pregnancy outcome. As per previous studies undertaken by the research team, this criterion will be assessed by review of relevant medical record fields and anyone who meets this criterion will be flagged to exclude from invitation to the study or from being included in any trial related data collection or contacts.
* No registered mobile phone number

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Maitland Hospital Maternity Services - Maitland
Recruitment hospital [2] 0 0
Manning Hospital Maternity Services - Taree
Recruitment postcode(s) [1] 0 0
2323 - Maitland
Recruitment postcode(s) [2] 0 0
2430 - Taree

Funding & Sponsors
Primary sponsor type
Other
Name
Hunter and New England Health
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melanie Kingsland, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 4924 6499
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06896292