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Trial registered on ANZCTR


Registration number
ACTRN12625000574448
Ethics application status
Approved
Date submitted
19/05/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the impact of dose in an mHealth intervention to support parents and carers across the first 2000 days of life: Is more always better?
Scientific title
Exploring how dose influences the acceptability, engagement, effectiveness and cost-effectiveness of a parent targeted mHealth text messaging program: comparing the impact of a ‘low’ vs ‘high’ dose.
Secondary ID [1] 314479 0
None
Universal Trial Number (UTN)
Trial acronym
HB4HNEKids
Linked study record
ACTRN12624001439538
ACTRN12624000655549p
These linked study records are sub-studies of this study.

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 337519 0
Condition category
Condition code
Public Health 333884 333884 0 0
Health service research
Public Health 333883 333883 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HB4HNEKids is text message program that targets infant feeding practices, child nutrition, physical activity and child development. The text messages are brief (<160 characters) with clickable links to evidence-based ‘online’ videos, fact sheets and websites. The text messages are aligned to the age, stage and developmental milestones of the child across the first 2000 days and for the first 12 months are tailored to the infant feeding status (e.g. breastfeeding, mixed feeding or formula feeding) of the participants. From 1-2 years content aligns with family health and wellbeing, as well as the promotion of healthy eating and movement behaviours.

The program includes four phases for the first 2 years of the program:
Phase 0- day 0 to day 2 (onboarding from child family health clinics)
Phase 1- day 3 to 6 months
Phase 2- 6-12 months
Phase 3- 1-2 years

The high dose group received up to 3-4 messages per week in the first month, 2 per week in the second month and 5 per month from 3 months to 2 years.
Adherence to the mhealth strategy was monitored via embedded link-click rates and responses to child feeding status messages.
Intervention code [1] 331103 0
Behaviour
Comparator / control treatment
Low dose group received up to 2 HB4HNEKids messages per week in the first month and approximately one per week for 2 months to 2 years.
Control group
Dose comparison

Outcomes
Primary outcome [1] 341522 0
Proportion breastfeeding
Assessment method [1] 341522 0
Participants were asked to respond to a message asking how they were feeding their child/ren. Possible feeding status responses included: breastmilk, mixed feeding, formula. To calculate breastfeeding status across the lifespan of the program, ‘assumed’ feeding status was used whereby the participant’s feeding status was carried over to the next phase of the program unless participants provided an update to their feeding status.
Timepoint [1] 341522 0
Days 21 (infant approximately 3 weeks old); Day 97 (infant approximately 3 months old); Day 169 (infant approximately 6 months old: Primary timepoint); Day 275 (infant approximately 9 months old); and Day 552 (infant approximately 18 months old).
Secondary outcome [1] 447828 0
Engagement with HB4HNEKids messages
Assessment method [1] 447828 0
The click rates for weblinks provided in text messages were tracked using a unique weblink shortener. Click rates were calculated based on the number of unique times a link had been clicked divided by the number of participants that had been sent the corresponding link.
Timepoint [1] 447828 0
For the first 2 years of the program.
Secondary outcome [2] 447831 0
Cost of sending the text messages
Assessment method [2] 447831 0
The cost of sending the messages via the SMS provide, DirectSMS was multiplied by the average numbers of text messages sent.
Timepoint [2] 447831 0
For the first 2 years of the program.
Secondary outcome [3] 447829 0
Opt out rates from HB4HNEKids
Assessment method [3] 447829 0
Participants were sent a message at day 1, 51, 296 and 461 that contained a link to opt out of the text messaging program. The opt out links were live for the curse of the program so that participants could opt-out at any time
Timepoint [3] 447829 0
For the first 2 years of the program.
Secondary outcome [4] 447830 0
Acceptability of HB4HNEKids
Assessment method [4] 447830 0
Participants completed a short online survey to determine acceptability using 3 survey items: 1) I found the Healthy Beginnings for HNEKids program acceptable; 2) Since I started the program, I have been happy with how often I have received the text messages; and 3) I would recommend the HB4HNEKids program to other caregivers. Participant responded along a 5-point Likert scale (strongly agree to strongly disagree).
Timepoint [4] 447830 0
Day 169 (infant approximately 5 months old)

Eligibility
Key inclusion criteria
Five Child Family Health (CFH) services in the Hunter New England (HNE) region of Australia were selected for inclusion in the pilot. Included CFH services met at least one of each of the following inclusion criteria:

Aboriginal CFH service (n=2)
Rural or remote CFH service (n=1)
Regional CFH service (n=1)
Metropolitan CFH service (n=1)

CFH services receive referrals from public and private maternity services following the birth of a baby and discharge of the mother/child from hospital. Women birthing within the catchment area of the included CFH services were offered HB4HNEKids as part of routine care. Women were eligible if they own a mobile phone.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Families that are not eligible for standard CFH care.

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 randomised into one of two intervention groups (high or low dose) in randomly sequenced blocks of 2 and 4 using a random number function set up by an independent statistician in SAS 9.3.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics were used to describe outcomes such as: the sample, cost and acceptability measures. An intention to treat approach was used in the analyses of all study outcomes, whereby analysis occurred according to the randomised treatment allocation (dose group). Between group differences in percentages were examined using Chi-square tests for each categorical outcome. The comparisons of interest included feeding status versus dose after each message feeding prompt, click rates versus dose stratified by feeding status, and opt-out rates versus dose during each study phase.? Analyses of the outcomes employed a two-tailed test with an alpha level of 5%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319018 0
Government body
Name [1] 319018 0
Hunter New England Local Health District (HNELHD)
Country [1] 319018 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District (HNELHD)
Country
Australia
Secondary sponsor category [1] 321481 0
University
Name [1] 321481 0
The University of Newcastle
Country [1] 321481 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317628 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 317628 0
Ethics committee country [1] 317628 0
Australia
Date submitted for ethics approval [1] 317628 0
05/06/2024
Approval date [1] 317628 0
07/06/2024
Ethics approval number [1] 317628 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 141618 0
A/Prof Rachel Sutherland
Address 141618 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 141618 0
Australia
Phone 141618 0
+61 2 4924 6499
Email 141618 0
Rachel.Sutherland@health.nsw.gov.au
Contact person for public queries
Name 141619 0
Dr Alison Brown
Address 141619 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 141619 0
Australia
Phone 141619 0
+61 2 4924 6499
Email 141619 0
Alison.Brown7@health.nsw.gov.au
Contact person for scientific queries
Name 141620 0
Dr Alison Brown
Address 141620 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 141620 0
Australia
Phone 141620 0
+61 2 4924 6499
Email 141620 0
Alison.Brown7@health.nsw.gov.au

Data sharing statement
Will the study consider sharing individual participant data?
No


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.