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Trial registered on ANZCTR


Registration number
ACTRN12623000363684
Ethics application status
Approved
Date submitted
17/03/2023
Date registered
12/04/2023
Date last updated
30/06/2023
Date data sharing statement initially provided
12/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility, acceptability, and potential efficacy of a mobile health intervention 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 mobile health intervention, the Eat Smart Play Smart App, for the promotion of healthy eating and physical activity in Out of School Hours Care (OSHC) services.
Secondary ID [1] 309099 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor nutrition 329180 0
Physical inactivity 329181 0
Childhood obesity 329182 0
Condition category
Condition code
Public Health 326148 326148 0 0
Health promotion/education
Diet and Nutrition 326415 326415 0 0
Obesity
Diet and Nutrition 326416 326416 0 0
Other diet and nutrition disorders

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 mobile health intervention for the promotion of healthy eating and physical activity in Out of School Hours Care (OSHC) services. The intervention is a mobile health application which includes information and practical tools aimed to upskill educators in the promotion of healthy eating and physical activity in their service. The mobile application is named the Eat Smart Play Smart App and was developed by investigators on this study. The App includes an extensive selection of physical activity videos and healthy recipes specifically designed for the OSHC sector, taking into consideration time, space and budget limitations. The App also includes nutrition and physical activity policy templates to support OSHC staff in developing policies suitable to their service, and an interactive menu planning tool designed to help educators create a menu plan for their service that is aligned with the Australian Dietary Guidelines. Additional features include a useful resources section which consists of relevant websites specific to OSHC for educators to access for further information. Push notifications are also included and were designed to encourage participants to implement the App’s information/tools into their service practice. The push notifications are sent twice weekly and the content of the messages provide useful tips and prompt users to engage in the App. All of the features within the App are designed to assist with necessary tasks for OSHC service directors and educators such as creating/ revising service menus, physical activity schedules and updating service policies. Services in the intervention group will have access to the App for the 12 week study duration. App usage is at the participants' discretion. Throughout the study, follow-up emails will be sent to encourage participant engagement with the App. App usage will be monitored via data analytics.
Intervention code [1] 325599 0
Lifestyle
Intervention code [2] 325600 0
Behaviour
Comparator / control treatment
The comparison/ control group have been wait-listed to receive access to download and use the Eat Smart Play Smart App at the end of the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 334095 0
Staff engagement in healthy eating promoting behaviours.

This will be assessed using the validated time-sampling observation tool; System for Observing Staff Promotion of 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 regular OSHC program and will be used to record the type and length of scheduled activities occurring. Staff behaviours captured by SOSPAN include staff encouragement of physical activity (eg, leading physical activity, verbally promoting physical activity, staff engagement in physical activity with children and providing children with multiple physical activity options) or discouragement of physical activity (eg, idle time, providing elimination games, children standing or waiting for a turn and withholding physical activity). Staff promotion and modelling of healthy eating behaviours are captured in SOSPAN via staff verbally promoting healthy eating, educating children on healthy eating and consuming healthy food and beverage options, or discouraging healthy eating by staff consuming inappropriate foods or drinks.
Timepoint [1] 334095 0
Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
Primary outcome [2] 334344 0
Staff engagement in physical activity promoting behaviours.

This will be assessed using the validated time-sampling observation tool; System for Observing Staff Promotion of 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 regular OSHC program and will be used to record the type and length of scheduled activities occurring. Staff behaviours captured by SOSPAN include staff encouragement of physical activity (eg, leading physical activity, verbally promoting physical activity, staff engagement in physical activity with children and providing children with multiple physical activity options) or discouragement of physical activity (eg, idle time, providing elimination games, children standing or waiting for a turn and withholding physical activity). Staff promotion and modelling of healthy eating behaviours are captured in SOSPAN via staff verbally promoting healthy eating, educating children on healthy eating and consuming healthy food and beverage options, or discouraging healthy eating by staff consuming inappropriate foods or drinks.
Timepoint [2] 334344 0
Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
Primary outcome [3] 334345 0
Frequency of provision of vegetables in out of school hours care services.

Data on the food and drink being served in each service will be collected through observation and photography. Information on the food offered, including frequency of fruits and vegetables served will be captured using a snack observation form developed from a measurement methodology conducted in a study of out of school hours care food environments by Crowe et al. (2022).
Timepoint [3] 334345 0
Timepoint - Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
Secondary outcome [1] 419388 0
Changes in program curriculum and policies relevant to healthy eating and physical activity in Out of School Hours Care (OSHC) services.

Assessing the healthy eating and physical activity policy environment with the Healthy Afterschool Activity and Nutrition Documentation (HAAND) tool. The HAAND instrument is a validated tool that will be used to guide and collect information on nutrition and physical activity policies and practices through a short interview with directors from each OSHC service. HAAND explores 11 healthy eating and 10 physical activity policy characteristics captured through a short, structured interview that is conducted on-site with the OSHC directors by trained data collectors. In short, HAAND evaluates the level at which service policies support healthy eating and physical activity characteristics through written policies, staff training, use of healthy eating and physical activity resources, time allocations and types of physical activity, healthy eating practices, and screen-time availability. In addition, a copy of the nutrition and physical activity policies, as well as weekly food receipts and menus, will be requested from each OSHC service. For the purpose of collecting nutrition and physical activity policy information, HAAND will be conducted with all OSHC services in the study.
Timepoint [1] 419388 0
Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
Secondary outcome [2] 419389 0
Changes in the physical activity environment in OSHC services assessed against physical activity policy and staff engagement in physical activity in each service, This will be assessed through direct observation, and by using the validated time-sampling observation tool; System for Observing Staff Promotion of 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. Staff behaviours captured by SOSPAN include staff encouragement of physical activity (eg, leading physical activity, verbally promoting physical activity, staff engagement in physical activity with children and providing children with multiple physical activity options) or discouragement of physical activity (eg, idle time, providing elimination games, children standing or waiting for a turn and withholding physical activity). Staff promotion and modelling of healthy eating behaviours are captured in SOSPAN via staff verbally promoting healthy eating, educating children on healthy eating and consuming healthy food and beverage options, or discouraging healthy eating by staff consuming inappropriate foods or drinks.
In addition, the Healthy Afterschool Activity and Nutrition Documentation (HAAND) instrument will be used to guide and collect information on nutrition and physical activity policies and practices through a short interview with directors from each OSHC service.
Timepoint [2] 419389 0
Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
Secondary outcome [3] 420296 0
THIS IS A PRIMARY OUTCOME: Frequency of provision of fruit in out of school hours care services.

Data on the food and drink being served in each service will be collected through observation and photography. Information on the food offered, including frequency of fruits and vegetables served will be captured using a snack observation form developed from a measurement methodology conducted in a study of out of school hours care food environments by Crowe et al. (2022).
Timepoint [3] 420296 0
THIS IS A PRIMARY OUTCOME TIMEPOINT: Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
Secondary outcome [4] 420297 0
THIS IS A PRIMARY OUTCOME: Feasibility of the intervention will be assessed by reviewing recruitment and attrition rates through an audit of study enrolment and withdrawal logs.
Timepoint [4] 420297 0
THIS IS A PRIMARY OUTCOME TIMEPOINT: Feasibility will be assessed after completion of follow-up data collection (conducted immediately after the 10 week intervention period).
Secondary outcome [5] 420298 0
THIS IS A PRIMARY OUTCOME: Acceptability of the intervention will be assessed using an online questionnaire sent to participants in the intervention group. The online questionnaire was created and distributed using REDCap electronic data capture tools. The questionnaire contains 29 questions related to the acceptability of the intervention and was developed by investigators on this study.
Timepoint [5] 420298 0
THIS IS A PRIMARY OUTCOME TIMEPOINT: Acceptability will be assessed after completion of follow-up data collection conducted immediately after the 12 week intervention period.
Secondary outcome [6] 420299 0
THIS IS A PRIMARY OUTCOME
Patterns of App usage will be captured using Google Analytics data across the study period.
Timepoint [6] 420299 0
THIS IS A PRIMARY OUTCOME TIMEPOINT
Patterns of usage will be assessed after completion of follow-up data collection (conducted immediately after the 10 week intervention period).

Eligibility
Key inclusion criteria
OSHC services must have ten or more primary school aged children (5-12 years old) who attend morning and afternoon programs between 0600- 0900 and 1430 - 1800 during school terms and during school holidays periods, OSHC services must provide food, and not exclusively advertise themselves as a homework or physical activity-related club (for eg. a dance, swim or football club).

Study participants are directors or educators employed in the recruited service and need to have a basic understanding of spoken and written English. Staff also need to have access to either a personal device (phone or tablet) or service device to receive access to the mobile App.
Minimum age
18 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 of OSHC services.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomised controlled trial - the OSHC service is the unit of analysis.
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 (n=15) are the unit of analysis for the potential efficacy outcomes as the study is looking at changes in service environments through staff behaviour in the promotion of healthy eating and physical activity and through food provision. All outcome data is collected at service level.
Descriptive data analysis will be performed using SPSS or JAMOVI. All analyses will be conducted using intention to treat principles. The process evaluation questionnaire will be analysed using basic descriptive data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2022
Date of last participant enrolment
Anticipated
Actual
24/02/2022
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313302 0
Government body
Name [1] 313302 0
NSW Ministry of Health
Country [1] 313302 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] 315045 0
Government body
Name [1] 315045 0
NSW Ministry of Health
Address [1] 315045 0
NSW Ministry of Health
1 Reserve Road
St Leonards NSW 2065
Australia
Country [1] 315045 0
Australia
Other collaborator category [1] 282581 0
Government body
Name [1] 282581 0
South Western Sydney Local Health District
Address [1] 282581 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
Liverpool NSW 2170
Country [1] 282581 0
Australia
Other collaborator category [2] 282582 0
Government body
Name [2] 282582 0
Illawarra-Shoalhaven Local Health District
Address [2] 282582 0
ISLHD Executive Office
Suite 2
Level 2, 67-71 King Street
Warrawong NSW 2502
Australia
Country [2] 282582 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312528 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
Ethics committee address [1] 312528 0
Ethics committee country [1] 312528 0
Australia
Date submitted for ethics approval [1] 312528 0
10/09/2021
Approval date [1] 312528 0
06/10/2021
Ethics approval number [1] 312528 0
2021/ETH11254: Evaluating the acceptability, feasibility, and potential effectiveness of a mobile Health intervention (the Eat Smart Play Smart App) for the promotion of healthy eating and physical activity in Outside School Hours Care (OSHC) services.

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

Contacts
Principal investigator
Name 124982 0
Prof Anthony Okely
Address 124982 0
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
Country 124982 0
Australia
Phone 124982 0
+61 2 4221 4641
Fax 124982 0
Email 124982 0
tokely@uow.edu.au
Contact person for public queries
Name 124983 0
Anthony Okely
Address 124983 0
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
Country 124983 0
Australia
Phone 124983 0
+61 2 4221 3555
Fax 124983 0
Email 124983 0
tokely@uow.edu.au
Contact person for scientific queries
Name 124984 0
Anthony Okely
Address 124984 0
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
Country 124984 0
Australia
Phone 124984 0
+61 2 4221 3555
Fax 124984 0
Email 124984 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
18541Study protocol  tokely@uow.edu.au
18542Informed consent form  tokely@uow.edu.au
18543Ethical 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.