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Trial registered on ANZCTR
Registration number
ACTRN12625000903482
Ethics application status
Approved
Date submitted
1/08/2025
Date registered
20/08/2025
Date last updated
20/08/2025
Date data sharing statement initially provided
20/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Helping New Parents Feel Good and Function Well After Childbirth: A Study Testing Text Messages to Support Mental Wellbeing
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Scientific title
Postnatal Mental Wellbeing Support for Birthing Parents: A Randomised Controlled Trial of a Co-Designed Text Message Intervention within the Healthy Beginnings for HNE Kids Program
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Secondary ID [1]
315049
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
ACTRN12624000655549
ACTRN12624001439538
ACTRN12625000574448
This record is a sub-study of the linked study records above related to the Healthy Beginnings for HNE Kids program.
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Health condition
Health condition(s) or problem(s) studied:
Parent mental wellbeing
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Condition category
Condition code
Public Health
334714
334714
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0
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Health promotion/education
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Public Health
334715
334715
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0
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Health service research
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Reproductive Health and Childbirth
334807
334807
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Healthy Beginnings for Hunter New England Kids (HB4HNEKids) is a digital health model of care delivered via mobile health (mHealth) text messages. This trial will specifically evaluate the impact of a new mental wellbeing module embedded within the HB4HNEKids program. The module includes 20 co-designed text messages delivered over five months, starting four weeks after childbirth. Content was developed using behaviour change theory and informed by focus groups and interviews with regional and rural parents and clinicians to ensure relevance, practicality, and theoretical rigour. Messages were pilot tested for acceptability, with feedback used to refine content. The module covers topics such as normalising emotional changes after childbirth, self-care and coping strategies, strengthening parent–infant connection, and how and when to seek additional mental health support.
All participants in the trial receive the standard HB4HNEKids program; those in the intervention group also receive the mental wellbeing module, while the control group receives the standard program only.
The HB4HNEKids program provides families with evidence-based, age- and stage-appropriate preventive health information from birth to five years. Content includes anticipatory guidance on child health and development, breastfeeding, nutrition, physical activity, movement behaviours, and family/carer wellbeing, as well as reminders for immunisation and health and development checks.
Families enrolled in HB4HNEKids receive short text messages (up to 160 characters) with embedded links to credible online resources, such as videos, fact sheets, websites and local support services. Messages are sent approximately once per week from birth to age three, and once per fortnight from ages three to five. Message delivery is monitored via SMS reports, and engagement with content is tracked using a URL analytics platform. Adherence to the intervention is assessed using these engagement metrics, opt-out rates, and follow-up Computer-Assisted Telephone Interviews (CATI) at 6 and 12 months postpartum to ask participants about message use and relevance.
Most messages are one-way and alpha-tagged with the program name; however, messages requesting feeding information are two-way to support tailoring. The intervention includes basic personalisation: using the child’s first name in some messages and adapting content to their current mode of milk feeding as well as specific age and stage milestones, to enhance relevance and user engagement.
Participants are provided with multiple opportunities to opt out of receiving the program throughout the intervention period (birth to 6 months postpartum). Unsubscribe links are sent via text messages when the child is 1, 3, 10, and 20 weeks old, and remain active for future use. Beyond the trial period, unsubscribe links are sent 2-4 times per year until the child turns five. An opt-out option is also available via the ‘Contact Us’ section of the program website, which includes the project team’s email address and phone number. Additionally, families can request to withdraw from the program during any interaction with the Child and Family Health Service.
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Intervention code [1]
331654
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Prevention
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Intervention code [2]
331655
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Behaviour
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Intervention code [3]
331656
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Lifestyle
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Comparator / control treatment
The control group will receive the existing HB4HNEKids program, as described above, as part of usual service delivery provided by Child and Family Health Services.
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Control group
Active
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Outcomes
Primary outcome [1]
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Mental wellbeing
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Assessment method [1]
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Mental wellbeing will be measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS), a validated self-report tool. Data will be collected via self-administered online surveys distributed to participants at 6 months postpartum, immediately following the wellbeing intervention. Participants will receive a secure survey link via SMS. Surveys will be administered using Research Electronic Data Capture (REDCap), a secure, web-based platform hosted by the Hunter New England Local Health District (HNELHD). Participants who do not complete the survey within one week will receive a follow-up telephone call from a member of the research team. During this call, participants will be reminded to complete the survey and offered entry into a monthly prize draw for a $30 grocery gift card as an incentive. They may also choose to complete the survey during the phone call or request the link to be resent.
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Timepoint [1]
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Immediately post-completion of intervention (at 6 months postpartum)
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Secondary outcome [1]
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Parental self-efficacy
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Assessment method [1]
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Measured using the validated Me As A Parent (MaaP) Scale – Short Form questionnaire, administered via online survey
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Timepoint [1]
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6 months postpartum.
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Secondary outcome [2]
450565
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Parent engagement
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Assessment method [2]
450565
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Engagement with the mental wellbeing text message content will be assessed through click-through rates on embedded URLs, using message analytics and link-tracking platforms.
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Timepoint [2]
450565
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6 months postpartum
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Secondary outcome [3]
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Opt-out rates
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Assessment method [3]
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Opt-out rates will be calculated based on the proportion of participants who discontinue participation via embedded unsubscribe links in messages, or through direct contact recorded by the research team.
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Timepoint [3]
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Data will be collected continuously throughout the intervention period.
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Secondary outcome [4]
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Acceptability
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Assessment method [4]
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Acceptability will be measured using three items informed by the Theoretical Framework of Acceptability (TFA), covering domains of affective attitude, burden (dose), and intervention coherence. Each item will be rated on a 5-point Likert scale (strongly agree to strongly disagree).
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Timepoint [4]
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6 months postpartum
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Eligibility
Key inclusion criteria
Parents are eligible to participate if they:
1) Have a newborn baby
2) Own a mobile phone
3) Are eligible for HB4HNEKids as part of Child and Family Health service appointments within HNELHD
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Parents will be excluded if they:
1) Are not eligible for HB4HNEKids as part of Child and Family Health Services (CFHS)
2) Initially access CFHS located in a postcode within the Greater Newcastle sector (as these postcodes are involved in a separate ongoing RCT within the HB4HNEKids program).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group using block randomisation with variable block sizes of 2 and 4. The randomisation sequence will be computer-generated by an independent statistician using a random number function in Microsoft Excel.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A total of 406 birthing parents (203 per group) is targeted. Target follow-up completions are 122 (61 per group). This allows detection of a 2-point difference in SWEMWBS (SD 3.9), 80% power, a=0.05. This assumes a survey completion rate of 30%, informed by prior response patterns.
Trial outcomes will be analysed under an intention to treat framework. To assess effectiveness on health behaviours, we will compare between group difference using mixed logistic and linear regression models. The model will include fixed effects for parent demographics that are found to be significantly different between intervention arms to account for potential bias. Sub-group analyses based on parent characteristics will also be conducted to examine differential effects of the intervention arms against the outcome. All statistical tests will be 2 tailed with an alpha of 0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
406
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Hunter New England Local Health District
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Address [1]
319611
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Country [1]
319611
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Australia
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Primary sponsor type
Government body
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Name
Hunter New England Local Health District
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Address
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Country
Australia
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Secondary sponsor category [1]
322116
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University
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Name [1]
322116
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University of Newcastle
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Address [1]
322116
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Country [1]
322116
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Australia
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Other collaborator category [1]
283612
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Other Collaborative groups
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Name [1]
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Hunter Medical Research Institute
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Address [1]
283612
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Country [1]
283612
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318175
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
318175
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https://www.hnehealth.nsw.gov.au/research-office/research_ethics
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Ethics committee country [1]
318175
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Australia
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Date submitted for ethics approval [1]
318175
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01/12/2023
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Approval date [1]
318175
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20/12/2023
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Ethics approval number [1]
318175
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2023/ETH02782
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Summary
Brief summary
This study will evaluate a new module of text messages designed to support postnatal mental wellbeing, embedded within the Healthy Beginnings for HNEKids (HB4HNEKids) mobile health program. Mental wellbeing in the perinatal period, including positive affect, emotional regulation, social connection, and purpose, is critical for both parents and children but is often overlooked in favour of treating mental illness alone. This two-arm, parallel-group randomised controlled trial will compare the HB4HNEKids program with and without the additional wellbeing module. Participants will be birthing parents, randomly allocated after birth. The primary outcome is parental mental wellbeing at six months postpartum, measured through validated self-report tools.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Rachel Sutherland
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Address
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Hunter New England Local Health District, Population Health. Locked Bag 1, New Lambton NSW 2305
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Country
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Australia
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Phone
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+61 2 4924 6499
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Fax
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Email
143358
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[email protected]
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Contact person for public queries
Name
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Nayerra Hudson
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Address
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Hunter New England Local Health District, Population Health. Locked Bag 1, New Lambton NSW 2305
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Country
143359
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Australia
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Phone
143359
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+61 2 4924 6499
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Fax
143359
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Email
143359
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[email protected]
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Contact person for scientific queries
Name
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Rebecca Liackman
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Address
143360
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Hunter New England Local Health District, Population Health. Locked Bag 1, New Lambton NSW 2305
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Country
143360
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Australia
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Phone
143360
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+61 2 4924 6499
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Fax
143360
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Email
143360
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Study protocol and information about linked studies can be provided upon reasonable request.
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.
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