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Trial registered on ANZCTR


Registration number
ACTRN12616000767404
Ethics application status
Approved
Date submitted
12/05/2016
Date registered
10/06/2016
Date last updated
10/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Active Minds, Happy Kids in Preschools: centre-based intervention feasibility study to increase physical activity, and decrease sedentary behaviour and screen time in preschool children
Scientific title
Active Minds, Happy Kids in Preschools: centre-based intervention feasibility study targeting physical environment and practice changes to increase physical activity, and decrease sedentary behaviour and screen time in preschool children.
Secondary ID [1] 289202 0
Nil
Universal Trial Number (UTN)
U1111-1182-8279
Trial acronym
AMHK in Preschools
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 298756 0
Sedentary behaviour 298757 0
Screen time 298759 0
Condition category
Condition code
Public Health 298809 298809 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active minds, happy kids is a centre-based a intervention feasibility study which aims to increase physical activity, decrease sedentary behaviour, and decrease screen time. It is a 10 week pre- and post-intervention feasibility study to develop, implement and evaluate centre-based behaviour change strategies. Four preschools and/or childcare centres (hereafter collectively referred to as centres), and five families per centre, will be recruited.

Strategies align with the ecological model, targeting individual, social and physical environment characteristics. All strategies will be implemented into existing curriculum (e.g. replacing sedentary story time with active story time) and are designed to be simple to deliver. Teachers will be provided a 30-60 minutes, in-house training session by experienced research staff (all teachers at each centre will be trained at the same time if available; training will be tailored to meet teacher and centre needs). Some of the strategies will include removing chairs from tables to create standing stations, active rather than passive story time, energy breaks, etc. They will also be provided an online education module (which teachers can access at their leisure) covering topics relevant to preschooler’s physical activity and sedentary behaviour. In 2015, Hinkley discussed proposed strategies with a convenience sample of teachers who commented on acceptability; strategies have been modified as necessary. All training will take place prior to implementation of the intervention. Teachers will be provided with on-going support by researchers throughout implementation, by request through phone call, email, and/or speak to the teachers in person if needed. Research staff will contact centre staff at least fortnightly throughout implementation of the program to provide an opportunity for question and support. Centres will also be provided with equipment to support physical activity to the value of $200. A small alarm clock will be provided to each centre to facilitate implementation of the energy breaks (2-3 mins of activity after every 30 mins of indoor time).

To assess intervention adherence, teachers will complete a log of centre activities undertaken (e.g. energy breaks, active story time) throughout the intervention period.
Intervention code [1] 294734 0
Behaviour
Intervention code [2] 294735 0
Prevention
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298277 0
Change in time spent in physical activity measured using ActiGraph accelerometer (internationally recognised and used activity monitors). Children will be wearing the monitor during waking hours for 7 days at each timepoint.
Timepoint [1] 298277 0
At baseline and end of intervention (during the final week of implementation).
Primary outcome [2] 298373 0
Change in time spent in sedentary behaviour measured using ActivPAL (internationally recognised and used activity monitors). Children will be wearing the monitor for during waking hours 7 days at each timepoint.
Timepoint [2] 298373 0
At baseline and end of intervention (during the final week of implementation).
Secondary outcome [1] 323732 0
Change in child screen time pre- to post-intervention. Outcome assessed by parent questionnaire. The questionnaire will capture children’s time in a number of types of screen time including TV viewing, computer use, smart phones and digital tablets. Parents will report their child’s usual week and weekend day time using each of the screen devices.
Parents questionnaire: Participant parents will complete a short online survey pre- and post-intervention to report on demographic family characteristics (pre- only), child behaviours (active play, screen time; pre- and post-) and to assess knowledge of the program (post- only); non-participant parents at each centre will be provided with the option of completing a shortened version of the survey anonymously post-intervention to assess program reach. The questionnaires are designed specifically for this study.
Timepoint [1] 323732 0
At baseline and end of intervention (during the final week of implementation).
Secondary outcome [2] 323961 0
Centre environments: Trained research assistants will audit centre environment characteristics (e.g. availability and placement of equipment, use of chairs). A modified version of a previously developed audit instrument will be used. The instrument draws from existing audit instruments (e.g. the NAP SACC, the EPAO) and includes checklists, observation points, and counts of items such as outdoor equipment, etc.
Timepoint [2] 323961 0
At baseline and end of intervention (during the final week of implementation).
Secondary outcome [3] 324595 0
Teacher characteristics: teachers will complete an online survey of demographic (e.g. age, education) at baseline and other relevant constructs (e.g. knowledge, self-efficacy to support child behaviours) at pre- and post-intervention. This survey is specifically designed for this study.
Timepoint [3] 324595 0
At baseline and end of intervention (during the final week of implementation).

Eligibility
Key inclusion criteria
In 2016, eligible participating families will have one child aged between 3-5 years who attends preschool at one of the participating preschools. The only inclusion criteria for families is having a child aged between 3 to 5 years old enrolled at one of the participating centres. Key inclusion criteria for centres is participation of five families and willingness to undertake intervention activities and implementation of strategies. This is our ONLY key inclusion criteria.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We do not have any exclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A-no control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/05/2016
Date of last participant enrolment
Anticipated
1/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293577 0
University
Name [1] 293577 0
Deakin University
Country [1] 293577 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 292396 0
Individual
Name [1] 292396 0
Dr Trina Hinkley
Address [1] 292396 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [1] 292396 0
Australia
Secondary sponsor category [2] 292397 0
Individual
Name [2] 292397 0
Dr Kylie Hesketh
Address [2] 292397 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [2] 292397 0
Australia
Secondary sponsor category [3] 292398 0
Individual
Name [3] 292398 0
Prof Jo Salmon
Address [3] 292398 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [3] 292398 0
Australia
Secondary sponsor category [4] 292399 0
Individual
Name [4] 292399 0
Prof Anna Timperio
Address [4] 292399 0
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [4] 292399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295024 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 295024 0
Ethics committee country [1] 295024 0
Australia
Date submitted for ethics approval [1] 295024 0
01/04/2016
Approval date [1] 295024 0
03/05/2016
Ethics approval number [1] 295024 0
2016-087

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

Contacts
Principal investigator
Name 65814 0
Dr Trina Hinkley
Address 65814 0
Deakin University 221 Burwood Hwy Burwood Vic 3125
Country 65814 0
Australia
Phone 65814 0
+61 3 9244 5480
Fax 65814 0
Email 65814 0
trina.hinkley@deakin.edu.au
Contact person for public queries
Name 65815 0
Trina Hinkley
Address 65815 0
Deakin University 221 Burwood Hwy Burwood Vic 3125
Country 65815 0
Australia
Phone 65815 0
+61 3 9244 5480
Fax 65815 0
Email 65815 0
trina.hinkley@deakin.edu.au
Contact person for scientific queries
Name 65816 0
Trina Hinkley
Address 65816 0
Deakin University 221 Burwood Hwy Burwood Vic 3125
Country 65816 0
Australia
Phone 65816 0
+61 3 9244 5480
Fax 65816 0
Email 65816 0
trina.hinkley@deakin.edu.au

No information has been provided regarding IPD availability


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.