Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000156482
Ethics application status
Approved
Date submitted
24/01/2025
Date registered
10/02/2025
Date last updated
27/04/2025
Date data sharing statement initially provided
10/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an online quality improvement tool developed for family day care to promote healthier nutrition and physical activity practices - phase 2.
Scientific title
Efficacy of an online quality improvement tool developed for service providers and educators in family day care to promote healthier nutrition and physical activity practices - phase 2.
Secondary ID [1] 313803 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study (phase 2) of the study ACTRN12623000369628. This phase 2 study is being conducted to test the intervention on a larger cohort which is representative of family day care services in NSW, Australia.

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 336439 0
Poor nutrition 336438 0
Condition category
Condition code
Public Health 332959 332959 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: Family Day Care Quality Improvement Toolkit

A website or online tool called "Family Day Care Quality Improvement Toolkit" was developed by Early Start University of Wollongong, in collaboration with NSW Health, and contains many features to assist in quality improvement in the family day care (FDC) sector. FDC service providers and educators will have access to the same tool/website, however accessible features will differ. The available features will be determined when a login is created for each participant before utilising the tool; each participant’s login will specify whether the participant is a service provider or an educator. All tool features for both service providers and educators are optional in terms of frequency of usage, as each service provider will have different processes of reviewing their QIP and it is up to them how they would like to use the tool's features.

The intervention group will be provided with access to the online support tool for use during the development or review of the service provider's Quality Improvement Plan (QIP). The tool is aimed at reviewing the nutrition and physical activity components of the QIP. For service providers who log in to the website, the website will have a tailored dashboard with visual and written summaries of their educator’s self-reflections and questionnaire performance, highlighting key priority areas related to Munch & Move practices. Service providers will also be able to pull these data to complete their required QIP with the option of utilising the tool’s Action Plan template, which was adapted from the Improvement Plan section of the Australian Children’s Education and Care Quality Authority (ACECQA) QIP template.

As the regular process of developing or reviewing the QIP involves service providers obtaining information regarding their educator’s practices and performance, service providers will be required to share the tool with some of their educators. Educators who login to the tool will have access to additional features of the tool; the questionnaire, self-assessment reflections, and tailored educational resources.

For educators who log in to the website, the tool will contain a self-assessment questionnaire which was developed based on the Munch & Move Monitoring Guide for Family Day Care Service Provider Practices and the Final Implementation Guide for Health Promotion Officers (HPOs) (both are internal documents from the Ministry of Health). The questionnaire will be designed to directly link with the relevant National Quality Standard and Munch & Move key messages, and each question given a rating out of 3 (0 = lowest score, 3 = highest score). After completion of the questionnaire, educators will be able to view their results and their performance based on the National Quality Standard and Munch & Move key messages. If an educator does not receive the highest rating (3/3) for a question, targeted educational resources will be provided.

There will also be a self-assessment reflection component that aims to guide educators on critical reflection of practices. This feature of the website will assist in linking reflections directly to the National Quality Standard, and provide prompts to ensure a thorough and good quality reflection is written. This self-assessment feature can also be accessed immediately after completion of the questionnaire, which will allow the educator’s reflection to directly link with the results of the questionnaire.

Recruitment of the study will run for a period of 6 months to coincide with the initial or annual review of QIP processes for many potential service providers and their registered educators. Each participating service provider and their educators will be asked to interact with the toolkit for a minimum of 4 weeks from when they receive access to the tool. This is to allow time for the service providers and educators to utilise the features of the tool and work on their QIP.

Adherence to the intervention will be monitored via accessing web-portal analytics.
Intervention code [1] 330392 0
Lifestyle
Comparator / control treatment
For the control group, service providers will develop or review their Quality Improvement Plan (QIP) as per their regular processes, without access to the online support tool. Control group services will be waitlisted to the intervention, receiving access to the online tool at the conclusion of follow-up data collection (which will occur immediately after the 4 week intervention/control period). This will allow them to use the tool during their next QIP review.
Control group
Active

Outcomes
Primary outcome [1] 340499 0
Changes in the quality of the service provider’s revised quality improvement plan (QIP) (in relation to the incorporation of nutrition and physical activity practices in the QIP).
Timepoint [1] 340499 0
Baseline and 1 month after intervention commencement.
Secondary outcome [1] 444448 0
Educator self-ratings of awareness and knowledge of Munch & Move practices.
Timepoint [1] 444448 0
Baseline and 1 month after intervention commencement.
Secondary outcome [2] 446853 0
Cost-effectiveness of the intervention.
Timepoint [2] 446853 0
The hours spent utilising the tool will be collected 1 month after intervention commencement. Website and domain fees will be recorded from commencement of the intervention to 1 month after intervention commencement (at the conclusion of the 4-week intervention period).
Secondary outcome [3] 444270 0
Service provider self-ratings of awareness and knowledge of Munch & Move practices.
Timepoint [3] 444270 0
Baseline and 1 month after intervention commencement.
Secondary outcome [4] 444449 0
Service provider self-ratings of awareness of the National Quality Standards.
Timepoint [4] 444449 0
Baseline and 1 month after intervention commencement.
Secondary outcome [5] 444451 0
Service provider self-ratings of importance of promoting nutrition and physical activity practices.
Timepoint [5] 444451 0
Baseline and 1 month after intervention commencement.
Secondary outcome [6] 444455 0
Educator self-ratings of confidence in identifying priority areas.
Timepoint [6] 444455 0
Baseline and 1 month after intervention commencement.
Secondary outcome [7] 444453 0
Service provider self-ratings of confidence in identifying priority areas.
Timepoint [7] 444453 0
Baseline and 1 month after intervention commencement.
Secondary outcome [8] 444452 0
Educator self-ratings of importance of promoting nutrition and physical activity practices.
Timepoint [8] 444452 0
Baseline and 1 month after intervention commencement.
Secondary outcome [9] 444450 0
Educator self-ratings of awareness of the National Quality Standards.
Timepoint [9] 444450 0
Baseline and 1 month after intervention commencement.

Eligibility
Key inclusion criteria
Participants must either be a current approved NSW family day care service provider or educator and must
- Be willing to provide informed consent and be willing to participate in the study.

For service providers only
- Be developing or undergoing a review of their quality improvement plan (QIP) during the recruitment period of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All participants (service providers and educators) will be excluded if they
- Do not have a basic understanding of spoken English.
- Participated in phase 1 of this research and therefore have used the online toolkit before.

For service providers only
- Will not be undergoing a review of their quality improvement plan (QIP) at some point during the 6 months of recruitment

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations for phase 2 are calculated using the results from phase 1 and aim to recruit a cohort which is representative of services in NSW, Australia. The sample size to ensure robust statistical power for detecting change in service providers QIPs will be as follows:

Sample size - 36 FDC service providers and 108 educators (3 educators per service).

Statistical analyses will be conducted using SPSS, and descriptive statistics will be calculated. The efficacy of the intervention will be tested using an intention-to-treat approach and linear mixed models. The Statistical Consulting Service will be used to advise on the most appropriate analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/03/2025
Actual
17/03/2025
Date of last participant enrolment
Anticipated
18/08/2025
Actual
Date of last data collection
Anticipated
22/09/2025
Actual
Sample size
Target
36
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318269 0
Government body
Name [1] 318269 0
NSW Health Prevention Research Support Program Round 6
Country [1] 318269 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Country
Australia
Secondary sponsor category [1] 320657 0
None
Name [1] 320657 0
Address [1] 320657 0
Country [1] 320657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316910 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 316910 0
Ethics committee country [1] 316910 0
Australia
Date submitted for ethics approval [1] 316910 0
20/01/2025
Approval date [1] 316910 0
31/01/2025
Ethics approval number [1] 316910 0
2023/ETH00212

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

Contacts
Principal investigator
Name 139402 0
Prof Anthony Okely
Address 139402 0
University of Wollongong Northfields Avenue, Wollongong, NSW 2522
Country 139402 0
Australia
Phone 139402 0
+61 425 227 616
Fax 139402 0
Email 139402 0
[email protected]
Contact person for public queries
Name 139403 0
Dr Andrew Woods
Address 139403 0
University of Wollongong Northfields Avenue, Wollongong, NSW 2522
Country 139403 0
Australia
Phone 139403 0
+61 2 4221 3555
Fax 139403 0
Email 139403 0
[email protected]
Contact person for scientific queries
Name 139404 0
Dr Andrew Woods
Address 139404 0
University of Wollongong Northfields Avenue, Wollongong, NSW 2522
Country 139404 0
Australia
Phone 139404 0
+61 2 4221 3555
Fax 139404 0
Email 139404 0
[email protected]

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.