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Trial registered on ANZCTR


Registration number
ACTRN12623000369628
Ethics application status
Approved
Date submitted
13/03/2023
Date registered
13/04/2023
Date last updated
21/01/2024
Date data sharing statement initially provided
13/04/2023
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.
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.
Secondary ID [1] 309161 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor nutrition 329284 0
Physical inactivity 329563 0
Condition category
Condition code
Public Health 326238 326238 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] 325610 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
Active

Outcomes
Primary outcome [1] 334111 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). 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.
Timepoint [1] 334111 0
Baseline and 1 month after intervention commencement
Secondary outcome [1] 419413 0
Change in the service provider's quality improvement plan (QIP) review process assessed qualitatively via an online interview with a nominated supervisor from each participating service provider
Timepoint [1] 419413 0
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

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
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
There is no target sample size as no accurate statistics exist on the number of registered family day care (FDC) service providers in NSW. In previous Early Start research studies in the FDC setting, the FDC sector has also proved to be a difficult sector to recruit due to their working schedules. Therefore, in the interest of completing the PhD (in which this study is part of) in an appropriate timeframe, the sample size will depend on the numbers we can obtain from recruitment.
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. Qualitative data obtained from interviews will grouped into themes and analysed using the NVIVO software program.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2023
Actual
10/07/2023
Date of last participant enrolment
Anticipated
Actual
1/12/2023
Date of last data collection
Anticipated
Actual
21/12/2023
Sample size
Target
10
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313361 0
University
Name [1] 313361 0
University of Wollongong
Country [1] 313361 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 315117 0
None
Name [1] 315117 0
Address [1] 315117 0
Country [1] 315117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312582 0
Human Research Ethics Committee of the University of Wollongong
Ethics committee address [1] 312582 0
Ethics committee country [1] 312582 0
Australia
Date submitted for ethics approval [1] 312582 0
20/02/2023
Approval date [1] 312582 0
24/03/2023
Ethics approval number [1] 312582 0
2023/ETH00212

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

Contacts
Principal investigator
Name 125174 0
A/Prof Bridget Kelly Gillott
Address 125174 0
University of Wollongong
Northfields Avenue, Wollongong, NSW 2522
Country 125174 0
Australia
Phone 125174 0
+61 2 4221 3893
Fax 125174 0
Email 125174 0
bkelly@uow.edu.au
Contact person for public queries
Name 125175 0
Georgie Tran
Address 125175 0
University of Wollongong
Northfields Avenue, Wollongong, NSW 2522
Country 125175 0
Australia
Phone 125175 0
+61 2 4221 3555
Fax 125175 0
Email 125175 0
glat997@uowmail.edu.au
Contact person for scientific queries
Name 125176 0
Georgie Tran
Address 125176 0
University of Wollongong
Northfields Avenue, Wollongong, NSW 2522
Country 125176 0
Australia
Phone 125176 0
+61 2 4221 3555
Fax 125176 0
Email 125176 0
glat997@uowmail.edu.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18556Study protocol  glat997@uowmail.edu.au
18557Informed consent form  glat997@uowmail.edu.au
18558Ethical approval  glat997@uowmail.edu.au



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.