Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000655549p
Ethics application status
Submitted, not yet approved
Date submitted
7/05/2024
Date registered
21/05/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
21/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Scaling up an effective digital model of care to optimise child health in the first 2000 days: Is ‘opt-in’ or ‘opt-out’ the best approach?
Scientific title
Scaling-up a digital model of care to optimise child health in the first 2000 days: Comparing the impact of a clinician initiated ‘opt-in’ model versus an automated ‘opt-out’ approach on reach, effectiveness and health system cost.
Secondary ID [1] 312092 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic disease 333727 0
Childhood obesity 333850 0
Childhood overweight 333851 0
Condition category
Condition code
Diet and Nutrition 330406 330406 0 0
Obesity
Public Health 330407 330407 0 0
Health promotion/education
Public Health 330408 330408 0 0
Health service research
Reproductive Health and Childbirth 330410 330410 0 0
Childbirth and postnatal care

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 with easy to access evidence based age and stage related preventive health information, targeting child health and development such a breastfeeding, child nutrition, movement behaviours and family/carer wellbeing, from birth to 5 years. Messages may 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. T he delivery of text messages are monitored via direct SMS reports (i.e. the number of messages successfully delivered), and engagement with text message context is monitored via a URL tracking platform ‘T2M’.
As part of the this trial, the intervention will focus on the implementation of an automated (opt-out) model. This will involve an automated health system intervention where parents will automatically receive the HB4HNEKids text message program and are able to ‘opt-out’. This will involve using existing data systems to generate reports to identify parents referred to the Community and Family Health Nursing (CFHN) service and eligible to receive HB4HNEKids. Client lists will be generated from these reports that will be used to trigger the commencement of the HB4HNEKids mHealth intervention direct to all parents mobile phones. HB4HNEKids has been designed to be delivered to eligible parents alongside usual CFHN care.
During the course of the intervention, parents will have multiple ways to opt out of the program. On average they will receive three text message links per year to opt out of the program, which they can return to at any time. An opt out link is available on the contact us section of the program website, as well as direct contact information (email and contact phone number) for the project team. During any interaction with the Child & Family Health Nursing Service families can also request to cease receiving the text messages.
The following strategies will be delivered to CFHN services via the generic program email:
1. A contact from each sector will be identified to distribute program information to CFHN clinicians.
2. A district wide report will be distributed to CFHN clinicians quarterly.
Intervention code [1] 328533 0
Prevention
Intervention code [2] 328571 0
Behaviour
Comparator / control treatment
Clinician onboarding (opt-in) model: Is a multicomponent implementation intervention targeting clinicians to support parents to ‘opt-in’ to receiving an evidenced based digital intervention ‘Healthy Beginnings for HNE Kids – HB4HNEKids’. As HB4HNEKids has been designed to be delivered to eligible parents alongside usual CFHN care, CFHN clinicians (Nurses, Aboriginal Health Workers, Managers and Allied Health Professionals) will be provided with four implementation strategies (provided by an allocated Health Promotion Officer) to support parents to ‘opt-in’ to receiving HB4HNEKids:
1. Identify and prepare Champions: a key contact from each sector will be identified and a support officer will be allocated to provide ongoing/tailored support.
2. Dynamic training: A training package will be available to all CFHN service staff allocated to the opt-in model. A live training session will be provided by the allocated support officer, that outlines onboarding procedures and a provides opportunity for a Q&A session. Recordings of training materials will be made available for ongoing support. These activities will be embedded into the onboarding process for new CFHN staff.
3. Tools and systems: A simple onboarding system will be developed to support clinicians to onboard parents/carers. An online MS Teams channel will also be established to provide access to live additional resources (such as flyers, comprehensive FAQs, onboarding procedures document and live access to all tools/training) and facilitate a Community of Practice via the chat function.
4. Audit and feedback: Tailored service reports (prepared by an allocated Health Promotion Officer) will be provided quarterly to service/managers.

Following the delivery of implementation strategies, CFHN clinicians will commence the onboarding of eligible families into HB4HNEKids within 4 weeks of receiving the support. Only new families entering the CFHN service (i.e. child <35 days old) will be invited to receive HB4HNEKids via the opt-in model.

Control group
Active

Outcomes
Primary outcome [1] 338159 0
Reach of HB4HNEKids.
Timepoint [1] 338159 0
4, 6, 12 and 18-months after commencement of the intervention.
Primary outcome [2] 338160 0
Representativeness of parents receiving HB4HNEKids.
Timepoint [2] 338160 0
Sample representativeness of parents receiving HB4HNEKids at baseline and those remaining engaged at 4, 6, 12 and 18-months after commencement of the intervention will be compared.
Secondary outcome [1] 434772 0
Proportion of any breastfeeding.
Timepoint [1] 434772 0
4, 6, 12 and 18 months after commencement of the intervention.
Secondary outcome [2] 434773 0
Mean child daily serves of vegetables.
Timepoint [2] 434773 0
12 and 18-months after commencement of the intervention.
Secondary outcome [3] 434774 0
Child immunisation rates
Timepoint [3] 434774 0
6 and 18 months after commencement of the intervention.
Secondary outcome [4] 434775 0
Cost-effectiveness of the models i.e. incremental cost per unit change (%) in reach.
Timepoint [4] 434775 0
18-months after the commencement of the intervention.
Secondary outcome [5] 434776 0
Parent engagement with HB4HNEKids
Timepoint [5] 434776 0
4, 6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [6] 434777 0
Clinician acceptability of the scale-up models.
Timepoint [6] 434777 0
4 months, 6 months and 18 months after the commencement of the intervention.
Secondary outcome [7] 434778 0
Parent acceptability of HB4HNEKids.
Timepoint [7] 434778 0
4, 6 and 12 months after commencement of the intervention.
Secondary outcome [8] 434779 0
Maintenance
Timepoint [8] 434779 0
18 months after the commencement of the intervention.
Secondary outcome [9] 434780 0
Implementation Context
Timepoint [9] 434780 0
baseline and 18-months after the commencement of the intervention.
Secondary outcome [10] 434781 0
Fidelity of implementation strategies.
Timepoint [10] 434781 0
12 and 18 months after the commencement of the intervention.
Secondary outcome [11] 434782 0
Adaptations
Timepoint [11] 434782 0
Throughout the 18-month intervention delivery period.
Secondary outcome [12] 435065 0
Mean child daily serves of fruit
Timepoint [12] 435065 0
12 and 18-months after commencement of the intervention.
Secondary outcome [13] 435066 0
Mean child daily serves of discretionary foods.
Timepoint [13] 435066 0
12 and 18-months after commencement of the intervention
Secondary outcome [14] 435067 0
Clinician feasibility of the scale-up models.
Timepoint [14] 435067 0
4 months, 6 months and 18 months after the commencement of the intervention.
Secondary outcome [15] 435068 0
Clinician appropriateness of the scale-up models.
Timepoint [15] 435068 0
4 months, 6 months and 18 months after the commencement of the intervention.
Secondary outcome [16] 435069 0
Parent feasibility of HB4HNEKids.
Timepoint [16] 435069 0
4, 6 and 12 months after commencement of the intervention.
Secondary outcome [17] 435070 0
Parent appropriateness of HB4HNEKids.
Timepoint [17] 435070 0
4, 6 and 12 months after commencement of the intervention.

Eligibility
Key inclusion criteria
51 CFHN services, located across 7 sectors (Tablelands, Peel, Mehi, Lower Mid North Coast, Maitland/Lower Hunter, Hunter Valley and Greater Newcastle) of the Hunter New England local health district of New South Wales Australia will be eligible for implementing the scale-up of HB4HNEKids .
These services offer care to approximately 10,000 new families each year. Parents are eligible if they own a mobile phone, and are eligible for CFHN appointments provided by the 51 CFHN services mentioned above.
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 CFHN care will be excluded.

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)
Simple randomisation using a random number generator. Stratified allocation by sector location (i.e. rural or regional) and number of births in the sector per year.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on recent birth data (collected for a full financial year 2022-23) across the HNE region of NSW Australia. Groups including CFHNs from 3 sectors are estimated to reach approximately 2300 families during a 12-month period. Based on the assumption that the opt-out model will reach 50% of the population at 18-months follow-up, this trial will be powered to detect an 11.9% difference in reach, assuming a clustering effect with 80% power, an alpha of 0.04 and ICC of 0.01.
Trial outcomes will be analysed under an intention to treat framework. For the primary trial outcome (reach of HB4HNEKids) between group differences will be assessed using mixed logistic regressions to account for any potential service level clustering effects. The regression model will include fixed effects for each model of care and pre-specified covariates prognostic of the outcome.
To assess effectiveness on child health behaviours, we will compare between group difference for the whole cohort regardless of their level of exposure to the HB4HNEKids program using mixed logistic and linear regression models. We will conduct exploratory analyses investigating effects among those who enrolled in the program and received messages. The model will include fixed effects for service and parent demographics that are found to be significantly different between scale-up models to account for potential consenting bias. Sub-group analyses based on parent characteristics will also be conducted to examine differential effects of the models of care 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
8/07/2024
Actual
Date of last participant enrolment
Anticipated
7/07/2025
Actual
Date of last data collection
Anticipated
11/01/2027
Actual
Sample size
Target
4600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316449 0
Government body
Name [1] 316449 0
Hunter New England Local Health District (HNELHD)
Country [1] 316449 0
Australia
Primary sponsor type
Government body
Name
HNELHD
Address
Country
Australia
Secondary sponsor category [1] 318620 0
University
Name [1] 318620 0
University of Newcastle
Address [1] 318620 0
Country [1] 318620 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315240 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315240 0
Ethics committee country [1] 315240 0
Australia
Date submitted for ethics approval [1] 315240 0
27/03/2024
Approval date [1] 315240 0
Ethics approval number [1] 315240 0

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

Contacts
Principal investigator
Name 134102 0
A/Prof Rachel Sutherland
Address 134102 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 134102 0
Australia
Phone 134102 0
+61 2 4924 6499
Fax 134102 0
Email 134102 0
Rachel.Sutherland@health.nsw.gov.au
Contact person for public queries
Name 134103 0
Nayerra Hudson
Address 134103 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 134103 0
Australia
Phone 134103 0
+61 2 4924 6499
Fax 134103 0
Email 134103 0
Nayerra.Hudson@health.nsw.gov.au
Contact person for scientific queries
Name 134104 0
Dr Alison Brown
Address 134104 0
Hunter New England Local Health District, Population Health. Locked bag 1, New Lambton NSW 2305
Country 134104 0
Australia
Phone 134104 0
+61 2 4924 6499
Fax 134104 0
Email 134104 0
Alison.Brown7@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.