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DEFINITIONS
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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.
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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.
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Secondary ID [1]
313803
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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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.
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Health condition
Health condition(s) or problem(s) studied:
Physical inactivity
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Poor nutrition
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Condition category
Condition code
Public Health
332959
332959
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330392
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
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The service’s previous QIP will be validated against a checklist designed specifically for the study. The checklist assesses both the incorporation of nutrition and physical activity practices together, as a composite outcome. The revised QIP post-intervention will also be validated against the same checklist.
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Timepoint [1]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [1]
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Educator self-ratings of awareness and knowledge of Munch & Move practices.
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Assessment method [1]
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This will be collected using an online survey designed for this study.
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Timepoint [1]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [2]
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Cost-effectiveness of the intervention.
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Assessment method [2]
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An incremental cost-effectiveness ratio (ICER) will be calculated of the intervention. This will be a composite figure calculated through: a question in the online survey at post-intervention asking intervention group educators and service providers to estimate how many hours they utilised the tool during the 4-week intervention; and website and domain hosting fees which will be recorded during the intervention.
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Timepoint [2]
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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).
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Secondary outcome [3]
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Service provider self-ratings of awareness and knowledge of Munch & Move practices.
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Assessment method [3]
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This will be collected using an online survey designed for this study.
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Timepoint [3]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [4]
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Service provider self-ratings of awareness of the National Quality Standards.
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Assessment method [4]
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This will be collected using an online survey designed for this study.
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Timepoint [4]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [5]
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Service provider self-ratings of importance of promoting nutrition and physical activity practices.
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Assessment method [5]
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This will be collected using an online survey designed for this study.
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Timepoint [5]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [6]
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Educator self-ratings of confidence in identifying priority areas.
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Assessment method [6]
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This will be collected using an online survey designed for this study.
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Timepoint [6]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [7]
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Service provider self-ratings of confidence in identifying priority areas.
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Assessment method [7]
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This will be collected using an online survey designed for this study.
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Timepoint [7]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [8]
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Educator self-ratings of importance of promoting nutrition and physical activity practices.
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Assessment method [8]
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This will be collected using an online survey designed for this study.
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Timepoint [8]
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Baseline and 1 month after intervention commencement.
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Secondary outcome [9]
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Educator self-ratings of awareness of the National Quality Standards.
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Assessment method [9]
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This will be collected using an online survey designed for this study.
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Timepoint [9]
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Baseline and 1 month after intervention commencement.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
17/03/2025
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Actual
17/03/2025
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Date of last participant enrolment
Anticipated
18/08/2025
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Actual
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Date of last data collection
Anticipated
22/09/2025
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Actual
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Sample size
Target
36
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Accrual to date
2
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NSW Health Prevention Research Support Program Round 6
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Wollongong
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320657
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Country [1]
320657
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Greater Western Human Research Ethics Committee
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Ethics committee address [1]
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https://www.medicalresearch.nsw.gov.au/policies-guidelines/?popup=directories_popup_9526&keyword=hrec
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/01/2025
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Approval date [1]
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31/01/2025
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Ethics approval number [1]
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2023/ETH00212
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Summary
Brief summary
The aim of this study is to explore the effects of an online quality improvement tool developed for service providers and educators in family day care to promote healthier nutrition and physical activity practices. it is hypothesised that using the online tool will improve the quality of the service provider's revised quality improvement plan (QIP) compared to the service provider's previous QIP.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Anthony Okely
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Address
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University of Wollongong Northfields Avenue, Wollongong, NSW 2522
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Country
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Australia
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Phone
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+61 425 227 616
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Andrew Woods
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Address
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University of Wollongong Northfields Avenue, Wollongong, NSW 2522
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Country
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Australia
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Phone
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+61 2 4221 3555
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Andrew Woods
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Address
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University of Wollongong Northfields Avenue, Wollongong, NSW 2522
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Country
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Australia
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Phone
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+61 2 4221 3555
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Fax
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Email
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[email protected]
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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.
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