Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000928314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
22/06/2026
Date registered
Help: Date registered
28/07/2026
Date last updated
Help: Date last updated
22/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The BLOOM program - testing the impact of an online platform supporting child social and emotional learning together with healthy eating and movement in early years setting.
Scientific title
A randomised controlled trial to evaluate the BLOOM program, a digital intervention integrating social and emotional learning, physical activity, and nutrition, in early childhood education and care settings to enhance preschoolers’ self-regulation and wellbeing
Additional trial identifiers [1] 317557 0
MRF2035593
Universal Trial Number (UTN)
Trial acronym
BLOOM (Building Lifestyle skills and Optimising emOtional Mastery)
Related trial records

Health condition
Health condition(s) studied:
Early child development 342307 0
Self-regulation 342344 0
Mental health 342345 0
Condition category
Condition code
Mental Health 338478 338478 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 338479 338479 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Building Life skills and Optimising emOtional Mastery (BLOOM) program is a primarily digital intervention, The platform supports ECEC educators to implement social and emotional learning practices in meal and play times to improve self-regulation and wellbeing outcomes for children aged 3-5 years.

Strategies for ECEC services include:
- Nominated Supervisor and educators (usually a room leader) participates in 1 x ~45 minute initial meeting where a trained facilitator will outline the rationale for the program, program requirements and provide support to navigate and use the BLOOM portal. Adherence will be monitored by researchers using an attendance checklist.
- Educators will be invited to participate in free online training through recorded videos (the Preschool Situational Self-Regulation Toolkit (PRSIST) program). The PRSIST training is developed by investigators on the team and includes 9 self-paced online modules which are between 4-16 minutes in duration. Each module provides information around self-regulation (e.g. what it is, importance, how to support children's development). Educators will be asked to complete this training in the course of the BLOOM program. Attendance will be recorded via a monitoring form completed by the Nominated Supervisor.
- Services will be asked to distribute educational materials to families through 4 short information snippets. Adherence will be monitored within the BLOOM portal and through check ins with the research team.
- Nominated Supervisors to participate in 1 x 30-minute support call at approximately mid-intervention to ask about progress, discuss potential barriers and facilitators and collaborative identify solutions (if required). Adherence will be monitored by researchers using an attendance checklist.
- Select service champion (leader). Adherence will be monitored by researchers using monitoring checklist.

The support that will be offered to ECEC services includes, but is not limited to,
- The digital portal that supports managers and room leaders to: i) self-assess their implementation of targeted social and emotional learning practices; ii) prioritise and develop an action plan; and, iii) communicate program activities with parents by providing templates/resources. Adherence will be monitored via analytics.
- Formal implementation blueprint (i.e. electronic Action Plan) that will outline all ECEC service goals, responsibilities and expectations of the program. Adherence will be monitored via portal analytics.
- Local technical support will be provided in the form of support calls between the service by a research team member. Adherence will be monitored by researchers using monitoring checklist.
- Printed handbook outlining BLOOM practices provided at intervention commencement.

Strategies for parents/primary caregivers include:
- Access to the BLOOM x Daily Growth app which provides 2 x daily videos resources tailored to the parents' circumstances for 6 weeks (pending their response to 2 x 1-minute surveys each day). After the 6 weeks, parents will have access to all videos regardless of their responses to the surveys. Adherence will be monitored via video analytics.

The support that will be offered to parents includes, but is not limited to:
- Provision of 4 short information snippets by ECEC services
- Provision of 6 BLOOM e-newsletters delivered by researchers - Access to video resources via the BLOOM x Daily Growth app (see above)
Intervention code [1] 334391 0
Prevention
Intervention code [2] 334392 0
Behaviour
Description of the comparator or control
ECEC services and parents allocated to the control group will receive usual care. For ECEC services, this may include general support from health promotion teams to implement the state-funded obesity prevention program. This does not include social and emotional learning practices. For parents this includes access to usual child and family health sites and government resources.
Control group
Active

Outcomes
Primary outcome [1] 345767 0
Child self-regulation score
Timepoint [1] 345767 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [1] 463214 0
Child fussy eating
Timepoint [1] 463214 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [2] 463215 0
Child fruit and vegetable intake
Timepoint [2] 463215 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [3] 463216 0
Duration of outdoor play time
Timepoint [3] 463216 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [4] 463219 0
Child sedentary behaviour
Timepoint [4] 463219 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [5] 463220 0
Child depressive symptoms
Timepoint [5] 463220 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [6] 463221 0
Child cognitive self-regulation
Timepoint [6] 463221 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [7] 463222 0
Child behavioural self-regulation
Timepoint [7] 463222 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [8] 463223 0
Child emotional self-regulation
Timepoint [8] 463223 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [9] 463224 0
Child sociability
Timepoint [9] 463224 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [10] 463229 0
Child prosocial behaviour
Timepoint [10] 463229 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [11] 464434 0
Child internalising behaviour
Timepoint [11] 464434 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [12] 464435 0
Child externalising behaviour
Timepoint [12] 464435 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [13] 464436 0
Adverse events
Timepoint [13] 464436 0
Baseline and post-intervention (approximately 6 months)
Secondary outcome [14] 464944 0
Child sugar sweetened beverages consumption
Timepoint [14] 464944 0
Baseline and post-intervention (approximately 6 months)

Eligibility
Key inclusion criteria
ECEC services will be eligible if: i) they enrol at least 25 children aged between 3-5 years and ii) have internet access. ECEC educators who report previously accessing the PRSIST program website will still be eligible to participate given the additional components offered as part of the BLOOM program, however, we will assess how long ago educators accessed this program.

ECEC educators will be eligible to participate if they are primarily working in the room that caters to 3-6 years olds in a consenting ECEC service.

Children will be eligible if they: i) are 3-5 years during recruitment; ii) parents have provided informed consent for participation and report attending this ECEC at least 2 days/week; and, iv) have parental consent. If a family has more than one eligible child, both will be eligible for inclusion but parents will receive the intervention once.

Parents of children will be eligible to participate if they: i) have a mobile phone with web capabilities (e.g. 4G/5G) and ii) can understand English sufficiently to engage with the intervention.
Minimum age
3 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Mobile preschools, home-based care, Department of Education services and services who cater exclusively for children requiring specialist care will be excluded (<5 % of services).

Parents who report previously engaging with the Daily Growth app in the past six months will be ineligible to participate.

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)
Services will be randomly assigned following primary outcome baseline data collection. The randomisation schedule will be generated by a blinded researcher, and off-site allocation will occur following baseline data collection. Following random allocation, services will be notified of their group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Services will be randomly assigned to the intervention or control group in a 1:1 ratio using a random number function. Randomization will be stratified by socioeconomic status (SES) based on Socio-Economic Indexes for Areas classification using the centre postcode and service size given the association with primary outcomes. Randomization will be conducted by a member of the research team who is not involved in day-to-day research activities.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation is based on the primary outcome: child self-regulation at 6-months follow-up. Based on published norms, the standard deviation is estimated at 1.08 and the anticipated mean score is approximately 3.57. To detect an absolute difference of 0.32 in self-regulation scores (classed as a small effect size) 25 with 80% power, two-sided 5% significance level and intracluster correlation coefficient of 0.08, a sample size of 20 centres (16 children per centre) and 320 children is required. Accounting for approximately 30% attrition (consistent with that achieve by previous studies undertaken by CIs), a final sample size of 448 children (28 centres, approximately 16 per centre will be recruited). Based on previously published studies on association, such an effect could potentially reduce the risk of depressive symptoms and anxiety by between 20-30% in later life. Attrition bias will also be assessed by comparing those lost to follow up and those retained in the trial on participants key characteristics including SES and obtaining, where possible from the ECEC centre staff, reasons for attrition for families.

Consistent with best practice, the primary analyses will be undertaken under an intention–to-treat framework, using multiple imputation to account for missing data. For the primary outcome, between-group differences will be assessed for paired data using 2-level hierarchical linear regression models. Models will be adjusted for centre level clustering through a random effect and controlled for baseline measures and centre SES. We will also undertake sensitivity analysis assessing the impact on the primary outcome for those that have download the BLOOM x Daily Growth app.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
27/10/2026
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
448
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 322114 0
Government body
Name [1] 322114 0
Department of Health, Disability and Ageing - Medical Research Future Fund
Country [1] 322114 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 325036 0
Other
Name [1] 325036 0
Hunter Medical Research Institute
Address [1] 325036 0
Country [1] 325036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320643 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 320643 0
Ethics committee country [1] 320643 0
Australia
Date submitted for ethics approval [1] 320643 0
22/10/2025
Approval date [1] 320643 0
06/03/2026
Ethics approval number [1] 320643 0

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

Contacts
Principal investigator
Name 151150 0
A/Prof Sze Lin Yoong
Address 151150 0
Deakin University, 221 Burwood Highway Burwood, Victoria 3125
Country 151150 0
Australia
Phone 151150 0
+61 3 924 68173
Fax 151150 0
Email 151150 0
[email protected]
Contact person for public queries
Name 151151 0
Sze Lin Yoong
Address 151151 0
Deakin University, 221 Burwood Highway Burwood, Victoria 3125
Country 151151 0
Australia
Phone 151151 0
+61 3 924 68173
Fax 151151 0
Email 151151 0
[email protected]
Contact person for scientific queries
Name 151152 0
Sze Lin Yoong
Address 151152 0
Deakin University, 221 Burwood Highway Burwood, Victoria 3125
Country 151152 0
Australia
Phone 151152 0
+61 3 924 68173
Fax 151152 0
Email 151152 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Request pending costs and time required to access relevant 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.