Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000042145
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
14/01/2019
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A brief intervention to increase child physical activity levels in childcare: the Everybody Energise trial
Scientific title
A randomised controlled trial of a brief structured physical activity intervention (i.e. energisers) to increase the physical activity of young children aged 3-6 years attending centre-based childcare services
Secondary ID [1] 297001 0
None
Universal Trial Number (UTN)
U1111-1226-3748
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 310972 0
Condition category
Condition code
Public Health 309634 309634 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An intervention to increase the time children spend in moderate to vigorous physical activity in childcare will be delivered to participating centre-based childcare services randomly allocated to the intervention group. Specifically, within a six hour day (9am-3pm) the intervention will involve childcare services implementing three brief (5 minute) structured physical activity sessions (energisers) each day for children aged 3 to 6 years. The energisers will involve educators leading all children in a brief activity or active game with the aim of increasing children's moderate to vigorous physical activity levels. Suggested energisers will be provided as an educational resource for educators. All other service practices will remain unchanged. Childcare services will receive support from the research team to implement three energisers each week day for a period of six months. The intervention will be guided by the socio-ecological framework and will involve the following components: i) obtaining service manager endorsement of the intervention; ii) face-to-face educational meeting with service manager and lead educators; iii) local consensus process with service manager and educators; iv) provision of educational resources designed specifically for this study; and v) tailored telephone support from the research team on a minimum of two occasions throughout the intervention period.
Intervention code [1] 313275 0
Prevention
Intervention code [2] 313276 0
Lifestyle
Intervention code [3] 313277 0
Behaviour
Comparator / control treatment
The control group will not receive any support from the research team throughout the study period
Control group
Active

Outcomes
Primary outcome [1] 318592 0
Minutes children spend in moderate to vigorous physical activity from the time that children arrive at care until 3pm (the time where majority of children are in care), assessed via accelerometer using recommended cut-points. Accelerometer data will be collected on three consecutive days over one week.
Timepoint [1] 318592 0
At baseline and at the end of the intervention period (approximately six months following baseline).
Secondary outcome [1] 365467 0
Proportion time in moderate to vigorous physical activity out of total activity in care assessed via accelerometer. Accelerometer data will be collected on three consecutive days over one week.
Timepoint [1] 365467 0
At baseline and at the end of the intervention period (approximately six months following baseline).
Secondary outcome [2] 365468 0
Total child activity in care (assessed via counts per 5 sec epoch), assessed via accelerometer. Accelerometer data will be collected on three consecutive days over one week.
Timepoint [2] 365468 0
At baseline and at the end of the intervention period (approximately six months following baseline).
Secondary outcome [3] 365469 0
Minutes children spend sedentary, assessed via accelerometer. Accelerometer data will be collected on three consecutive days over one week.
Timepoint [3] 365469 0
At baseline and at the end of the intervention period (approximately six months following baseline).
Secondary outcome [4] 365470 0
Measures of child cognitive function (inhibition; visual-spatial working memory; shifting; phonological working memory; executive functioning and vocabulary) assessed via validated tools (Early Years Toolbox) (composite secondary outcome).
Timepoint [4] 365470 0
At baseline and at the end of the intervention period (approximately six months following baseline).
Secondary outcome [5] 365471 0
Measures of feasibility of the intervention for delivery at scale and childcare service organisational capacity assessed via questionnaire developed by the research team for this study (composite secondary outcome).
Timepoint [5] 365471 0
At the end of the intervention period (approximately six months following baseline).

Eligibility
Key inclusion criteria
Centre-based childcare services (long day care services and preschools)
To be eligible to participate in the trial, services will be located in the Hunter region of NSW, Australia and will be required to have a daily enrolment of least 40 children aged between 3 to 6 years.

Parents
For parents to be eligible to participate in the trial, they must have at least one child aged 3 to 6 years attending the childcare service on at least one day of the designated data collection period.

Children
For children within the service to be eligible to participate in the trial, they must be aged 3 to 6 years, have parental consent and attend childcare on at least one day of the designated data collection period.
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Centre-based childcare services (long day care services and preschools)
Services catering solely for special needs populations will be excluded from participating in the trial, as will services already implementing daily energisers. NSW Department of Education and Communities services will also be excluded, together with services currently participating in alternate trials aiming to improve nutrition and/or physical activity.

Children
Children with an intellectual or physical impairment that may impact on their physical activity capacity or prevent them from complying with data collection protocols will be excluded from participating in the trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Childcare services
A list of all centre-based childcare services (preschools and long day care services) located within the study region will be obtained from the NSW Ministry of Health and will serve as the sampling frame (approximately n=420). The Nominated Supervisor of eligible services will be sent an information letter informing them about the study and requesting permission to recruit parents through their service. Approximately one week following the distribution of the information letters, a research assistant will telephone Nominated Supervisors to answer any questions they may have and to confirm their eligibility, consent or otherwise. Random allocation of services to groups will occur following baseline data collection. Allocation to groups will be conducted by an independent statistician, at a centralised location.

Parents/children
A member of the research team will arrange for recruitment packs (one per parent of each enrolled child aged 3 to 6 years) to be delivered to each participating service. Distribution of these packs to parents will occur via methods considered most effective and appropriate by the Nominated Supervisor in communicating with parents (e.g. placed in children’s pigeon holes or lockers, or handed directly to parents at drop-off or pick-up). The recruitment pack will contain an information sheet, consent form and return envelope. The information sheet will explain the study to parents and their opportunity to participate. Parents will be asked to return the consent form in the envelope provided to a drop-box at the service (supplied by the research team). Parents will have two to three weeks to return their consent form. Parents will be provided the direct phone number of a member of the research team to ask questions regarding research participation. One to two weeks after delivery of the recruitment packs, staff will be present at the childcare service, reminding parents of the study and the opportunity to participate. The research team has previously employed all methods of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting childcare services will be randomly allocated to an intervention or control group in a 1:1 ratio via block randomisation using a random number function in SAS statistical software following baseline data collection. Allocation of services will be undertaken by an independent statistician who will otherwise have no involvement in the study. Randomisation of childcare services will be stratified by the socioeconomic status of the area where the service is located, and the service type (preschool or long day care service).
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalised Linear Mixed Models (GLMM), to take account of the clustering of individual children within services, will be used under an intention to treat framework to examine changes in the study outcomes between groups over time. Data on child physical activity and cognitive function will be assessed on a cohort of children.
The study will approach approximately 420 children from 14 childcare services across the study region. Assuming the standard deviation of moderate to vigorous physical activity is 21 minutes and assuming an intraclass correlation coefficient of 0.07, a sample of 30 children per cluster will be sufficient to detect a change of 10 minutes in moderate to vigorous physical activity in care, with 80% power and an alpha of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
1/05/2019
Actual
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301573 0
Government body
Name [1] 301573 0
Hunter New England Population Health
Country [1] 301573 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Population Health
Address
Longworth Avenue, Wallsend, NSW 2287
Country
Australia
Secondary sponsor category [1] 301268 0
University
Name [1] 301268 0
University of Newcastle
Address [1] 301268 0
University Drive, Callaghan NSW 2308
Country [1] 301268 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302301 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 302301 0
Ethics committee country [1] 302301 0
Australia
Date submitted for ethics approval [1] 302301 0
12/11/2018
Approval date [1] 302301 0
20/12/2018
Ethics approval number [1] 302301 0
06/07/26/4.04

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

Contacts
Principal investigator
Name 89750 0
Dr Jannah Jones
Address 89750 0
Hunter New England Population Health
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Australia
Country 89750 0
Australia
Phone 89750 0
+61 2 4924 6047
Fax 89750 0
Email 89750 0
[email protected]
Contact person for public queries
Name 89751 0
Jannah Jones
Address 89751 0
Hunter New England Population Health
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Australia
Country 89751 0
Australia
Phone 89751 0
+61 2 4924 6047
Fax 89751 0
Email 89751 0
[email protected]
Contact person for scientific queries
Name 89752 0
Jannah Jones
Address 89752 0
Hunter New England Population Health
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Australia
Country 89752 0
Australia
Phone 89752 0
+61 2 4924 6047
Fax 89752 0
Email 89752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified datasets and all study materials will be available on request from the
principal investigator.
When will data be available (start and end dates)?
Following publication of study outcomes, no end date.
Available to whom?
Requests for data will be assessed on a case-by-case basis at the discretion of the investigators.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access will be provided subject to approvals by the investigators.


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.