Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001439538
Ethics application status
Approved
Date submitted
19/11/2024
Date registered
11/12/2024
Date last updated
11/12/2024
Date data sharing statement initially provided
11/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising the effectiveness of a digital health intervention to improve breastfeeding rates in children
Scientific title
Optimising the effectiveness of a digital health intervention to improve breastfeeding rates in children: a 2x2 factorial trial
Secondary ID [1] 313409 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
HB4HNEKids is a text-messaging intervention providing parents within the HNE region of NSW Australia with age and stage relevant information from birth until their child is 5 years of age.
Linked study ACTRN12624000655549 is a sub-study of the HB4HNEKids program, testing the impact of offering the program to families via child family health services (i.e. clinician-initiated on-boarding) or via an automated health system. The primary outcome of this linked study is program reach.

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight 335791 0
Childhood obesity 335790 0
Chronic disease 335789 0
Condition category
Condition code
Public Health 332360 332360 0 0
Health service research
Reproductive Health and Childbirth 332363 332363 0 0
Breast feeding
Diet and Nutrition 332364 332364 0 0
Obesity
Public Health 332359 332359 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy Beginnings for Hunter New England Kids (HB4HNEKids) is a digital health model of care delivered via mHealth (text message) that provides families access to evidence-based age and stage related preventive health care, targeting child health and development, breastfeeding, child nutrition, movement behaviours and family/carer wellbeing, from birth to 5 years based on anticipatory guidance. Messages also include immunisation and personal health and development check reminders.

Families eligible for HB4HNEKids receive short text messages (160 characters) with clickable links to evidence based ‘online’ videos, fact sheets, websites and relevant support services on average once/week in the first 3 years, and once/fortnight up until the age of 5 years. The delivery of text messages are monitored via SMS reports (i.e. the number of messages successfully delivered), and engagement with text message content is monitored via a URL tracking platform. The existing messages including the breastfeeding module has been piloted via a non-randomised post design and demonstrated a 5% (non-significant) difference in the proportion of mothers breastfeeding at 6 months.

This research, via a 2x2 factorial randomised trial will aim to optimise the HB4HNEKids program breastfeeding module and assess the effectiveness of the optimised mHealth intervention on improved infant feeding outcomes at 4 and 6 months. The experimental conditions that will be evaluated include:
• Experimental condition 1: messages will be sent to secondary carers/support persons that aim to support the breastfeeding parent. Upon enrolment to HB4HNEKids, a support person will begin to receive text messages for the first 6 months of a child’s life that aim to provide information to support the breastfeeding parent. The breastfeeding parent will continue to receive usual care as part of HB4HNEKids. The secondary carers/support persons messages have been specifically designed for the secondary carers/support persons, thus the set of 29 messages (i.e. approximately 1 message per week) will be sent to the secondary carer/support persons, that are different from those received by the breastfeeding parent.
• Experimental condition 2: an intensive breastfeeding message package will be developed that aims to address key barriers to breastfeeding aligned to each component of the Behaviour Change Wheel. Breastfeeding text, including an additional 8 text messages in total. Breastfeeding text messages will be sent regularly in addition to the existing messages (i.e. approximately 1 additional message every 3 weeks) for the first 6 months of the child’s life or until the parent stops breastfeeding.

Parents will be randomised to one of four groups:
Group A will receive experimental condition 1 only.
Group B will receive experimental condition 2 only.
Group C will receive both experimental conditions 1 and 2.
Group D is the control group (existing breastfeeding messages).

Adherence for each group will be monitored via project records and link clicks.
Intervention code [1] 329983 0
Prevention
Intervention code [2] 329984 0
Behaviour
Comparator / control treatment
Control (Group D): 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.
Control group
Active

Outcomes
Primary outcome [1] 339922 0
Any breastfeeding
Timepoint [1] 339922 0
4 months post-birth (when child has reached 4 months old)
Secondary outcome [1] 441923 0
Parent acceptability
Timepoint [1] 441923 0
6 months post-birth (when child has reached 6 months old)
Secondary outcome [2] 441920 0
Timing of the introduction of solids 
Timepoint [2] 441920 0
6 months post-birth (when child has reached 6 months old)
Secondary outcome [3] 441922 0
Opt out rates
Timepoint [3] 441922 0
Data will be continually collected throughout the duration of the intervention
Secondary outcome [4] 441918 0
Exclusive breastfeeding
Timepoint [4] 441918 0
4 and 6 months post-birth (when child has reached 4 and 6 months old)
Secondary outcome [5] 441921 0
Parent engagement 
Timepoint [5] 441921 0
6 months post-birth (when child has reached 6 months old)
Secondary outcome [6] 441919 0
Any breastfeeding
Timepoint [6] 441919 0
6 months post-birth (when child has reached 6 months old)
Secondary outcome [7] 441924 0
Breastfeeding self-efficacy
Timepoint [7] 441924 0
6 months post-birth (when child has reached 6 months old)

Eligibility
Key inclusion criteria
Parents are eligible to participate if they:
1) Have a newborn baby
2) Own a mobile phone
3) Eligible for HB4HNEKids as part of Child and Family Health service appointments within the Greater Newcastle area in the Hunter New England Local Health District
4) Are breastfeeding at the time of enrolment into the HB4HNEKids program.
5) Have indicated a support person that has access to a mobile phone
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents will be excluded if they:
1) Are not eligible for HB4HNEKids as part of Child and Family Health Services
2) Do not fall within the Greater Newcastle Child and Family Health Services catchment area
3) Are exclusively formula feeding at the time of enrolment into HB4HNEKids

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were block randomised (block sizes of 2 and 4) into one of the four intervention groups using a random number function.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 800 participants (n=200 per group) with an 80% power and an alpha of 0.05 will be required to detect an ~9% difference in breastfeeding status at 4 months.

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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2026
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317849 0
Government body
Name [1] 317849 0
Hunter New England Local Health District
Country [1] 317849 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District (HNELHD)
Address
Country
Australia
Secondary sponsor category [1] 320181 0
University
Name [1] 320181 0
The University of Newcastle
Address [1] 320181 0
Country [1] 320181 0
Australia
Other collaborator category [1] 283300 0
Other
Name [1] 283300 0
Hunter Medical Research Institute
Address [1] 283300 0
Country [1] 283300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316531 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316531 0
Ethics committee country [1] 316531 0
Australia
Date submitted for ethics approval [1] 316531 0
06/12/2023
Approval date [1] 316531 0
20/12/2023
Ethics approval number [1] 316531 0

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

Contacts
Principal investigator
Name 138178 0
A/Prof Rachel Sutherland
Address 138178 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 138178 0
Australia
Phone 138178 0
+61 2 4924 6499
Fax 138178 0
Email 138178 0
[email protected]
Contact person for public queries
Name 138179 0
Nayerra Hudson
Address 138179 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 138179 0
Australia
Phone 138179 0
+61 2 4924 6499
Fax 138179 0
Email 138179 0
[email protected]
Contact person for scientific queries
Name 138180 0
Dr Alison Brown
Address 138180 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 138180 0
Australia
Phone 138180 0
+61 2 4924 6499
Fax 138180 0
Email 138180 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: N/A



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.