Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000176662p
Ethics application status
Submitted, not yet approved
Date submitted
6/02/2023
Date registered
21/02/2023
Date last updated
21/02/2023
Date data sharing statement initially provided
21/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility, acceptability, and potential efficacy of a staff professional development program for the promotion of healthy eating and physical activity in Out of School Hours Care (OSHC) services.
Scientific title
Feasibility, acceptability, and potential efficacy of a staff professional development program for the promotion of healthy eating and physical activity in Out of School Hours Care (OSHC) services.
Secondary ID [1] 308921 0
Nil known
Universal Trial Number (UTN)
U1111-1288-0098
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor nutrition 328924 0
Physical inactivity 328925 0
Condition category
Condition code
Public Health 325914 325914 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the feasibility, acceptability, and potential efficacy of a staff professional development program for the promotion of healthy eating and physical activity in Out of School Hours Care (OSHC) services.

The intervention involves a staff professional development program aimed at educating and upskilling OSHC staff in the promotion of healthy eating and physical activity in their service. Staff will attend one face-to-face three-hour professional development session run by investigators on this study. The session will be held at a location mutually accessible to services participating in the intervention. If required, two professional development sessions will be held in different locations to assist with attendance.

The session will involve nutrition and physical activity education, and practical activities to teach skills around offering physical activity opportunities. A combination of PowerPoint presentation, worksheets having them create action plans, group discussion, role play and physical activity games will be used in the training. Staff will be encouraged to implement lessons learned into their service practice by completing their action plan and any necessary outputs from this (e.g. changing menus, rewriting nutrition policies, creating physical activity schedules etc.). Each service will develop their own action plan in the training, and set goals they believe are achievable over the following 4 weeks.

The intervention will utilise the recently developed Eat Smart Play Smart (ESPS) mobile phone App as a resource for participants and content. The ESPS App was developed by investigators on this project and consists of evidence-based healthy eating and physical activity information for OSHC staff. Participants will be encouraged to use the ESPS app at their own discretion.

After attending the professional development session, participants will implement the training for four weeks and receive ongoing curriculum support during this period. This ongoing support will involve a once weekly check-in phone call with the service director, and once weekly text messages/emails with service staff. The content of these text messages/emails will reinforce key learning from the professional development and provide links to additional resources. Ongoing support will also be catered to specific goals the service identified in their action plan. A photo of their action plan will be taken during the training and used for this purpose.

Implementation of the lessons learned in the training will be monitored through the weekly phone calls with service directors, where they will be asked about how well they are addressing their action plan. Baseline/follow up data collection methods will also help reveal changes they implemented to service structure/practice.
Intervention code [1] 325363 0
Lifestyle
Intervention code [2] 325364 0
Behaviour
Comparator / control treatment
The comparison/control group will be wait-listed to receive the treatment post-intervention. 2 weeks following completion of follow-up data collection, participants in the control group will be invited to attend a staff professional development session. This professional development session will be identical to that received by the intervention group, running for 3 hours and being delivered by investigators on this study.
Control group
Active

Outcomes
Primary outcome [1] 333752 0
Frequency of provision of fruit in before school care services.

Data on the food and drink being served in each before and after school care program will be collected through observation and photography. Information on the types of food on offer, including branding, will be captured using a snack observation form developed from a measurement methodology conducted in a study of after school care food environments by Crowe et al. (2022).
Timepoint [1] 333752 0
Collected at baseline (3 weeks before the intervention) and follow-up (immediately after the 4 week intervention period).
Primary outcome [2] 333753 0
Number of children obtaining 15 minutes of moderate-to-vigorous-intensity physical activity (MVPA) while attending before school care.

Objective physical activity levels of children attending before and after school care services in the study will be collected using ActiGraph accelerometers (wGT3X-BT models).
Timepoint [2] 333753 0
Collected at baseline (3 weeks before the intervention) and follow-up (immediately after the 4 week intervention period).
Primary outcome [3] 333754 0
Feasibility of the intervention will be assessed by reviewing recruitment and attrition rates through an audit of study enrolment and withdrawal logs.
Timepoint [3] 333754 0
Feasibility will be assessed after completion of follow-up data collection (conducted immediately after the 4 week intervention period).
Secondary outcome [1] 418183 0
Staff engagement in healthy eating and physical activity promoting behaviours.

This will be assessed using the validated time-sampling observation tool; System for Observing Physical Activity and Nutrition (SOSPAN). SOSPAN captures 13 physical activity and 6 healthy eating behaviours of staff, to indicate influences the children are receiving from educators. SOSPAN also captures the context of the program and will be used to record the type and length of scheduled activities occurring.
Timepoint [1] 418183 0
Collected at baseline (3 weeks before the intervention) and follow-up (immediately after the 4 week intervention period).
Secondary outcome [2] 418609 0
(Primary outcome)
Frequency of provision of vegetables in after school care services.

Data on the food and drink being served in each before and after school care program will be collected through observation and photography. Information on the types of food on offer, including branding, will be captured using a snack observation form developed from a measurement methodology conducted in a study of after school care food environments by Crowe et al. (2022).
Timepoint [2] 418609 0
Collected at baseline (3 weeks before the intervention) and follow-up (immediately after the 4 week intervention period).
Secondary outcome [3] 418610 0
(Primary outcome)
Number of children obtaining 30 minutes of MVPA while attending after school care.

Objective physical activity levels of children attending before and after school care services in the study will be collected using ActiGraph accelerometers (wGT3X-BT models).
Timepoint [3] 418610 0
Collected at baseline (3 weeks before the intervention) and follow-up (immediately after the 4 week intervention period).
Secondary outcome [4] 418611 0
(Primary outcome)
Acceptability of the intervention will be assessed using an online questionnaire created and distributed using RedCap electronic data capture tools. The questionnaire will contain 14 questions related to the acceptability of the intervention and was developed by investigators on this study.
Timepoint [4] 418611 0
Acceptability will be assessed immediately after follow-up data collection has been completed (conducted immediately after the 4 week intervention period). The questionnaire will be open for a period of 2 weeks.

Eligibility
Key inclusion criteria
To be eligible, services must enrol ten or more primary-aged children (5-12 years old) per morning and afternoon, run their program between 06:00 – 09:00 and 14:30 – 18:00 during school terms, provide food and not exclusively advertise themselves as a homework or physical activity-related club (e.g. swimming or football club).

Staff participants need to have a basic understanding of spoken and written English to participate. Participating OSHC staff also need to have access to a computer and mobile phone to receive professional development resources/curriculum.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Simple randomisation will be conducted by an individual not responsible for recruitment or participant eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be conducted using an online generated randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, the sample size is not designed to detect statistically significant differences between the intervention and control services. OSHC services are the unit of analysis for the potential efficacy outcomes as the study is looking at changes in service environments through food provision and child MVPA levels while attending the service. Feasibility and and acceptability is assessed using individual staff participants, however there is no target number for this as the amount of staff employed by the participating services is unknown until recruited.

Descriptive data analysis will be performed using SPSS. All analyses will be conducted using intention-to-treat principles. Binary logistic regression will be used to assess the impact of the intervention on the primary trial outcomes of services providing fruit and vegetables, and number of children meeting MVPA targets. Generalised estimating equations logistic regression models or mixed models will be used to assess the impact of the intervention on the secondary outcomes of changes in staff engagement in healthy eating and physical activity promoting behaviours. The process evaluation questionnaire will be analysed using basic descriptive data analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
3/04/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313130 0
Government body
Name [1] 313130 0
NSW Ministry of Health
Country [1] 313130 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Avenue
Wollongong NSW 2522 Australia
Country
Australia
Secondary sponsor category [1] 314831 0
Government body
Name [1] 314831 0
NSW Ministry of Health
Address [1] 314831 0
NSW Ministry of Health
1 Reserve Road
St Leonards NSW 2065
Australia
Country [1] 314831 0
Australia
Other collaborator category [1] 282545 0
Government body
Name [1] 282545 0
South Western Sydney Local Health District
Address [1] 282545 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
LIVERPOOL NSW 2170
Country [1] 282545 0
Australia
Other collaborator category [2] 282546 0
Government body
Name [2] 282546 0
Illawarra-Shoalhaven Local Health District
Address [2] 282546 0
ISLHD Executive Office
Suite 2
Level 2, 67-71 King Street
Warrawong NSW 2502
Country [2] 282546 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312375 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 312375 0
University of Wollongong
Northfields Ave
Wollongong, NSW 2522
Australia
Ethics committee country [1] 312375 0
Australia
Date submitted for ethics approval [1] 312375 0
24/01/2023
Approval date [1] 312375 0
Ethics approval number [1] 312375 0

Summary
Brief summary
This pilot study will assess the feasibility, acceptability and potential efficacy of a staff professional development intervention among Out of School Hours Care (OSHC) services to improve fruit and vegetable provision, child movement behaviours, and staff health promoting behaviours. A cluster parallel-group randomised controlled trial design will be used. The intervention will involve staff attending one three-hour professional development session, followed by four weeks of ongoing support.

Investigators of the current project have been conducting a study to co-design an OSHC intervention with key stakeholders from the OSHC sector. Through this study, stakeholders were presented with findings from previously conducted before and after school care observational studies; and contributed to discussions around what support was needed to bring about meaningful change. The intervention to be piloted in this study is being developed through this collaborative process.

It is hypothesised that OSHC services who participate in this intervention will increase their provision of fruit in before school care and vegetables in after school care. Children who attend these services will also have increased minutes of moderate-to-vigorous-intensity physical activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124434 0
Prof Anthony Okely
Address 124434 0
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
Country 124434 0
Australia
Phone 124434 0
+61 2 4221 4641
Fax 124434 0
Email 124434 0
tokely@uow.edu.au
Contact person for public queries
Name 124435 0
Prof Anthony Okely
Address 124435 0
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
Country 124435 0
Australia
Phone 124435 0
+61 2 4221 3555
Fax 124435 0
Email 124435 0
tokely@uow.edu.au
Contact person for scientific queries
Name 124436 0
Prof Anthony Okely
Address 124436 0
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
Country 124436 0
Australia
Phone 124436 0
+61 2 4221 3555
Fax 124436 0
Email 124436 0
tokely@uow.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
Participants will not be consenting to their data being used outside of the context of this research study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18249Study protocol  tokely@uow.edu.au
18250Informed consent form  tokely@uow.edu.au
18251Ethical approval  tokely@uow.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.