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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]

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

Condition category

Condition code

Public Health

Health promotion/education

Public Health

Health service research

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]

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]

Proportion breastfeeding

Timepoint [1]

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]

Engagement with HB4HNEKids messages

Timepoint [1]

For the first 2 years of the program.

Secondary outcome [2]

Opt out rates from HB4HNEKids

Timepoint [2]

For the first 2 years of the program.

Secondary outcome [3]

Acceptability of HB4HNEKids

Timepoint [3]

Day 169 (infant approximately 5 months old)

Secondary outcome [4]

Cost of sending the text messages

Timepoint [4]

For the first 2 years of the program.

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

1/10/2021

Date of last participant enrolment

Anticipated

Actual

1/05/2022

Date of last data collection

Anticipated

Actual

1/05/2024

Sample size

Target

5000

Accrual to date

Final

5858

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Hunter New England Local Health District (HNELHD)

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Hunter New England Local Health District (HNELHD)

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Newcastle

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

https://www.hnehealth.nsw.gov.au/research-office/research_ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/06/2024

Approval date [1]

07/06/2024

Ethics approval number [1]

Summary

Brief summary

Dose could have a direct response on the engagement of participants with mHealth programs, however currently there is minimal evidence regarding the optimal dose of messages in a parent targeted mHealth (text-messaging) intervention.  This study aims to explore how dose of text messages can influence the acceptability, engagement, effectiveness and cost of a parent targeted mHealth text messaging program, HB4HNEKids.  
We hypothesise that the higher dose of text messages will have a lower acceptability and engagement, similar effectiveness and higher cost compared with the lower dose text message arm.

Trial website

Trial related presentations / publications

Public notes

Please note: This trial was originally conducted as part of a health service improvement activity. The ethics approval was sought after the trial was conducted to publish the results from this trial given the lack of existing published data to guide practice. As such, we are also seeking to get retrospective trial registration.

Contacts

Principal investigator

Name

A/Prof Rachel Sutherland

Address

Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305

Country

Australia

Phone

+61 2 4924 6499

Fax

[email protected]

Contact person for public queries

Name

Dr Alison Brown

Address

Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305

Country

Australia

Phone

+61 2 4924 6499

Fax

[email protected]

Contact person for scientific queries

Name

Dr Alison Brown

Address

Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305

Country

Australia

Phone

+61 2 4924 6499

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant 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.

Trial Review

Documents added manually

Documents added automatically