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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
Date results information 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.
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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.
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Secondary ID [1]
309099
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Poor nutrition
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Physical inactivity
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Childhood obesity
329182
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Condition category
Condition code
Public Health
326148
326148
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0
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Health promotion/education
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Diet and Nutrition
326415
326415
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0
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Obesity
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Diet and Nutrition
326416
326416
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Lifestyle
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Intervention code [2]
325600
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
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Primary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
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Primary outcome [3]
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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).
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Assessment method [3]
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Timepoint [3]
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Timepoint - Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
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Secondary outcome [3]
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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).
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Assessment method [3]
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Timepoint [3]
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THIS IS A PRIMARY OUTCOME TIMEPOINT: Collected at baseline (4 weeks before the intervention) and follow-up (immediately after the 12 week intervention period).
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Secondary outcome [4]
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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.
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Assessment method [4]
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Timepoint [4]
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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).
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Secondary outcome [5]
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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.
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Assessment method [5]
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Timepoint [5]
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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.
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Secondary outcome [6]
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THIS IS A PRIMARY OUTCOME
Patterns of App usage will be captured using Google Analytics data across the study period.
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Assessment method [6]
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Timepoint [6]
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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).
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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.
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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
None
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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)
Simple randomisation will be conducted by an individual not responsible for recruitment or participant eligibility.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Randomised controlled trial - the OSHC service is the unit of analysis.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/02/2022
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Date of last participant enrolment
Anticipated
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Actual
24/02/2022
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Date of last data collection
Anticipated
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Actual
31/03/2023
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Sample size
Target
15
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Accrual to date
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Final
15
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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 Ministry of Health
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Address [1]
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NSW Ministry of Health
1 Reserve Road
St Leonards NSW 2065
Australia
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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
University of Wollongong
Northfields Avenue
Wollongong NSW 2522
Australia
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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NSW Ministry of Health
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Address [1]
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NSW Ministry of Health
1 Reserve Road
St Leonards NSW 2065
Australia
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Country [1]
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Australia
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Other collaborator category [1]
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Government body
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Name [1]
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South Western Sydney Local Health District
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Address [1]
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South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Corner of Lachlan and Hart Streets
Liverpool NSW 2170
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Country [1]
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Australia
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Other collaborator category [2]
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Government body
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Name [2]
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Illawarra-Shoalhaven Local Health District
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Address [2]
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ISLHD Executive Office
Suite 2
Level 2, 67-71 King Street
Warrawong NSW 2502
Australia
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Country [2]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee
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Ethics committee address [1]
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University of Wollongong
Northfields Ave
Wollongong, NSW 2522
Australia
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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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10/09/2021
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Approval date [1]
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06/10/2021
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Ethics approval number [1]
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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.
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Summary
Brief summary
This pilot study will assess the feasibility, acceptability and potential efficacy of a mobile health intervention among Out of School Hours Care (OSHC) services to improve staff health promoting behaviours, fruit and vegetable provision and physical activity environment. The study design is a parallel-group randomised controlled trial. The intervention involves a mobile application named The Eat Smart Play Smart App which is targeted at educator practices to address children’s healthy eating and physical activity. Investigators of the current project conducted a study to co-design an OSHC intervention with key stakeholders from the OSHC sector. During this study, stakeholders were presented with findings from a previously conducted state-wide quantitative survey of before and after school care services within NSW; and the stakeholders contributed to discussions around what support was needed to bring about meaningful change. The intervention piloted in this study has been developed through this collaborative process. It is hypothesised that OSHC services who participate in this intervention will increase their provision of fruit and vegetables in their OSHC service and educators from the services in the intervention group will have improved health promoting behaviours.
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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
Australia
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Country
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Australia
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Phone
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+61 2 4221 4641
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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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Prof Anthony Okely
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Address
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University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
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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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Prof Anthony Okely
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Address
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University of Wollongong
Northfields Avenue
Wollongong, NSW 2522
Australia
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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 individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Participants will not be consenting to their data being used outside of the context of this research study.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18541
Study protocol
[email protected]
18542
Informed consent form
[email protected]
18543
Ethical approval
[email protected]
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.
Download to PDF