Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000347460
Ethics application status
Approved
Date submitted
9/03/2016
Date registered
17/03/2016
Date last updated
13/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a scheduling of outdoor play intervention to increase physical activity in childcare
Scientific title
The efficacy of scheduling three periods of outdoor play vs one continuous period in increasing the time children spend in moderate-to-vigorous physical activity during childcare
Secondary ID [1] 288725 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity 297962 0
Condition category
Condition code
Public Health 298122 298122 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Specifically, within a six hour day (9am-3pm) the intervention will divide their usual total time of out-door play for children across three periods of at least 15 minutes' duration. The total daily duration of outdoor play will remain unchanged. There will be no prescribed timing for the scheduling of the outdoor play. Activities will remain unchanged.
The duration of the intervention period will be between approximately 3 months.
Services will be supported by a childhood physical activity consultant with experience working with childcare services to implement the intervention. Adherence will be monitored by the external consultant who will ensure the intervention is delivered as per protocol (unless inclement weather, special events or offsite activities)
Intervention code [1] 294161 0
Lifestyle
Intervention code [2] 294162 0
Prevention
Intervention code [3] 294163 0
Behaviour
Comparator / control treatment
No Treatment, standard care – instructed to continue their one outdoor play period of the same duration (except during inclement weather across the year)
Control group
Active

Outcomes
Primary outcome [1] 297628 0
Minutes children spend in moderate-to-vigorous physical activity from the time that children arrive at care until 3pm will be measured by accelerometers using recommended cut-points
Timepoint [1] 297628 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)
Secondary outcome [1] 321618 0
% time in MVPA out of total activity in care assessed by accelerometers
Timepoint [1] 321618 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)
Secondary outcome [2] 321619 0
Total volume of activity (assessed via counts per 5 sec epoch) will also be assessed using accelerometers
Timepoint [2] 321619 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)
Secondary outcome [3] 321620 0
Adverse events. Child injuries requiring documentation assessed via the Nominated Supervisor survey.
Timepoint [3] 321620 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)

Eligibility
Key inclusion criteria
Child care services (long day care and preschools)
For a service to be eligible it will be within the Hunter geographic region of NSW Australia and have a minimum total number of children enrolled aged 3-6 years of at least 25.
Children
For children within the service to be eligible to participate they will be aged 3-6 years, have parental consent and attend care during any of the days of designated data collection
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child care services (long day care and preschools)
Services serving special needs populations will be excluded from participating in the trial given the specialist care required for such children and the likelihood of a differential effect in this population group. Services with more than one outdoor play periods within the core hours of 9am to 3pm will be deemed ineligible.
Children
Children at the service with special needs 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)
Long Day Care Services and Preschools
A current list of all long day care services (LDCS) and preschools in the Hunter region which have licensed places for 3 to 6 year olds will be obtained from the NSW Department of Health. The Nominated Supervisor of eligible LDCS and preschools will be sent a letter informing them about the study and requesting permission to recruit parents through their service. Within two weeks from the initial information letters being sent, a study research assistant will telephone a Nominated Supervisor to answer any questions they may have and to confirm their eligibility, consent or otherwise.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician with no other involvement in recruitment or data collection will allocate services to either the intervention or control condition in a 1:1 ratio using a computerised random number generator.
Randomisation of services will be stratified by the socioeconomic status of the area where the service is located, and on service type (long day care service or preschool) based on evidence of an association between services locality and physical activity policies and practices of services.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/04/2016
Actual
8/04/2016
Date of last participant enrolment
Anticipated
Actual
11/11/2016
Date of last data collection
Anticipated
Actual
11/11/2016
Sample size
Target
600
Accrual to date
Final
419
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12861 0
2264 - Morisset
Recruitment postcode(s) [2] 12875 0
2291 - Merewether Heights
Recruitment postcode(s) [3] 12883 0
2304 - Mayfield
Recruitment postcode(s) [4] 13108 0
2286 - Holmesville
Recruitment postcode(s) [5] 13114 0
2303 - Hamilton South
Recruitment postcode(s) [6] 13120 0
2428 - Smiths Lake
Recruitment postcode(s) [7] 13455 0
2350 - Armidale
Recruitment postcode(s) [8] 13458 0
2380 - Gunnedah
Recruitment postcode(s) [9] 13470 0
2388 - Wee Waa
Recruitment postcode(s) [10] 17496 0
2337 - Scone

Funding & Sponsors
Funding source category [1] 293075 0
Government body
Name [1] 293075 0
National Health and Medical Research Council
Country [1] 293075 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Luke Wolfenden
Address
Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 291856 0
Government body
Name [1] 291856 0
Hunter New England Population Health
Address [1] 291856 0
Locked Bag 10, Wallsend NSW 2287 Australia
Country [1] 291856 0
Australia
Secondary sponsor category [2] 291923 0
University
Name [2] 291923 0
University of Newcastle School of Medicine and Public Health
Address [2] 291923 0
University Drive
Callaghan NSW 2308
Australia
Country [2] 291923 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294583 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 294583 0
Ethics committee country [1] 294583 0
Australia
Date submitted for ethics approval [1] 294583 0
30/10/2015
Approval date [1] 294583 0
09/03/2016
Ethics approval number [1] 294583 0
15/11/18/4.03

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2052 2052 0 0
/AnzctrAttachments/370303-Wolfenden 2016.pdf (Publication)

Contacts
Principal investigator
Name 64270 0
A/Prof Luke Wolfenden
Address 64270 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 64270 0
Australia
Phone 64270 0
+61 2 4985 5168
Fax 64270 0
Email 64270 0
[email protected]
Contact person for public queries
Name 64271 0
Lubna Abdul Razak
Address 64271 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 64271 0
Australia
Phone 64271 0
+61 2 4924 6305
Fax 64271 0
Email 64271 0
[email protected]
Contact person for scientific queries
Name 64272 0
Luke Wolfenden
Address 64272 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 64272 0
Australia
Phone 64272 0
+61 2 4985 5168
Fax 64272 0
Email 64272 0
[email protected]

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.