Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001008415
Ethics application status
Approved
Date submitted
27/07/2016
Date registered
1/08/2016
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Date results information initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a continuous indoor/outdoor play intervention to increase physical activity in childcare
Scientific title
The efficacy of scheduling continuous free indoor/outdoor play vs separate free indoor and outdoor play in increasing the time children spend in moderate-to-vigorous physical activity during childcare
Secondary ID [1] 289769 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 299643 0
Condition category
Condition code
Public Health 299594 299594 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 involve services implementing continuous free indoor/outdoor play for children. The only time when an opportunity for outdoor free play will be unavailable for children is when structured activity is occurring. At all other times, children will be free to move between indoors and outdoors as they wish. All other service activities will remain unchanged. The duration of the intervention period will be approximately 3 months.
Services will be supported by a childhood physical activity consultant with experience working with childcare services to implement the intervention. Support will be provided via service visits and telephone calls. 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] 295423 0
Lifestyle
Intervention code [2] 295424 0
Prevention
Comparator / control treatment
No treatment, standard care – instructed to continue their usual separate indoor and outdoor free play periods as usual (except during inclement weather across the year)
Control group
Active

Outcomes
Primary outcome [1] 299065 0
Minutes children spend in moderate-to-vigorous physical activity from the time that children arrive at care until 3pm, measured by accelerometers using recommended cut-points. Accelerometer data will be collected on every day of one week.
Timepoint [1] 299065 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)
Secondary outcome [1] 326053 0
% time in moderate-to-vigorous physical activity out of total activity in care assessed by accelerometers. Accelerometer data will be collected on every day of one week.
Timepoint [1] 326053 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)
Secondary outcome [2] 326054 0
Total volume of activity (assessed via counts per 5 sec epoch) will also be assessed using accelerometers. Accelerometer data will be collected on every day of one week.
Timepoint [2] 326054 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)
Secondary outcome [3] 326055 0
Adverse events. Child injuries requiring documentation assessed via Nominated Supervisor survey. The survey has been used in previous childcare-based physical activity studies.
Timepoint [3] 326055 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)
Secondary outcome [4] 328379 0
Measures of child cognitive function (inhibitions, visual-spatial working memory and shifting) assessed via validated tool (Early Years Toolbox)
Timepoint [4] 328379 0
At baseline and at the end of the intervention period (approximately 3 months after baseline)

Eligibility
Key inclusion criteria
Childcare services (long day care services and preschools)
For a service to be eligible it will be within the Hunter New England 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
Childcare services (long day care services 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 already implementing continuous indoor/outdoor play 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)
Childcare services
A current list of all childcare services in the Hunter New England 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 services 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.

Children
A member of the research team who will not be involved in intervention delivery will arrange for recruitment packs (one per parent of each enrolled child 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 engaging 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. Staff involved in recruitment of long day care services and children will be blind to the group allocation. Allocation to groups will be conducted by an independent statistician, at a centralised location using a computerised random number function. Random allocation of services to groups will occur following baseline data collection of children from childcare services.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician with no involvement in the study procedures 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 based on evidence of an association between services locality and services physical activity policies and practices.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2016
Actual
15/08/2016
Date of last participant enrolment
Anticipated
Actual
9/09/2016
Date of last data collection
Anticipated
16/12/2016
Actual
16/12/2016
Sample size
Target
100
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 13705 0
2290 - Mount Hutton
Recruitment postcode(s) [2] 13707 0
2320 - Maitland
Recruitment postcode(s) [3] 13708 0
2325 - Cessnock
Recruitment postcode(s) [4] 13709 0
2324 - Tea Gardens
Recruitment postcode(s) [5] 13710 0
2265 - Cooranbong
Recruitment postcode(s) [6] 13711 0
2322 - Thornton
Recruitment postcode(s) [7] 13712 0
2264 - Morisset
Recruitment postcode(s) [8] 13713 0
2264 - Bonnells Bay
Recruitment postcode(s) [9] 13714 0
2264 - Mirrabooka
Recruitment postcode(s) [10] 13715 0
2278 - Barnsley
Recruitment postcode(s) [11] 13716 0
2287 - Fletcher
Recruitment postcode(s) [12] 13717 0
2287 - Maryland
Recruitment postcode(s) [13] 13718 0
2289 - Kotara
Recruitment postcode(s) [14] 13719 0
2290 - Charlestown
Recruitment postcode(s) [15] 13720 0
2291 - Merewether Heights
Recruitment postcode(s) [16] 13721 0
2292 - Broadmeadow
Recruitment postcode(s) [17] 13722 0
2293 - Wickham
Recruitment postcode(s) [18] 13723 0
2297 - Tighes Hill
Recruitment postcode(s) [19] 13724 0
2298 - Waratah
Recruitment postcode(s) [20] 13725 0
2299 - Lambton
Recruitment postcode(s) [21] 13726 0
2300 - Newcastle
Recruitment postcode(s) [22] 13727 0
2303 - Hamilton
Recruitment postcode(s) [23] 13728 0
2304 - Mayfield
Recruitment postcode(s) [24] 13729 0
2305 - New Lambton
Recruitment postcode(s) [25] 13730 0
2308 - Callaghan
Recruitment postcode(s) [26] 13731 0
2312 - Nabiac
Recruitment postcode(s) [27] 13732 0
2319 - Tanilba Bay
Recruitment postcode(s) [28] 13733 0
2320 - Largs
Recruitment postcode(s) [29] 13734 0
2322 - Beresfield
Recruitment postcode(s) [30] 13735 0
2325 - Nulkaba
Recruitment postcode(s) [31] 13736 0
2326 - Abermain
Recruitment postcode(s) [32] 13737 0
2328 - Denman
Recruitment postcode(s) [33] 13738 0
2330 - Singleton
Recruitment postcode(s) [34] 13739 0
2422 - Gloucester
Recruitment postcode(s) [35] 13740 0
2428 - Forster
Recruitment postcode(s) [36] 13741 0
2428 - Tuncurry
Recruitment postcode(s) [37] 13742 0
2285 - Cardiff South
Recruitment postcode(s) [38] 13743 0
2283 - Toronto
Recruitment postcode(s) [39] 13744 0
2280 - Valentine
Recruitment postcode(s) [40] 13745 0
2280 - Belmont North
Recruitment postcode(s) [41] 13746 0
2282 - Eleebana
Recruitment postcode(s) [42] 13747 0
2259 - Wyee
Recruitment postcode(s) [43] 13748 0
2281 - Caves Beach
Recruitment postcode(s) [44] 13749 0
2267 - Wangi Wangi
Recruitment postcode(s) [45] 13750 0
2282 - Warners Bay
Recruitment postcode(s) [46] 13751 0
2283 - Arcadia Vale
Recruitment postcode(s) [47] 13752 0
2285 - Cameron Park
Recruitment postcode(s) [48] 13753 0
2285 - Glendale
Recruitment postcode(s) [49] 13754 0
2285 - Cardiff
Recruitment postcode(s) [50] 13755 0
2286 - Holmesville
Recruitment postcode(s) [51] 13756 0
2286 - West Wallsend
Recruitment postcode(s) [52] 13757 0
2287 - Wallsend
Recruitment postcode(s) [53] 13758 0
2287 - Rankin Park
Recruitment postcode(s) [54] 13759 0
2289 - Adamstown
Recruitment postcode(s) [55] 13760 0
2300 - Cooks Hill
Recruitment postcode(s) [56] 13761 0
2303 - Hamilton South
Recruitment postcode(s) [57] 13762 0
2295 - Stockton
Recruitment postcode(s) [58] 13763 0
2323 - Metford
Recruitment postcode(s) [59] 13764 0
2324 - Heatherbrae
Recruitment postcode(s) [60] 13765 0
2324 - Raymond Terrace
Recruitment postcode(s) [61] 13766 0
2334 - Greta
Recruitment postcode(s) [62] 13767 0
2428 - Smiths Lake
Recruitment postcode(s) [63] 13768 0
2306 - Windale
Recruitment postcode(s) [64] 13769 0
2307 - Shortland
Recruitment postcode(s) [65] 13770 0
2315 - Nelson Bay
Recruitment postcode(s) [66] 13771 0
2317 - Salamander Bay
Recruitment postcode(s) [67] 13772 0
2323 - East Maitland
Recruitment postcode(s) [68] 13773 0
2323 - Ashtonfield
Recruitment postcode(s) [69] 13774 0
2324 - Hawks Nest
Recruitment postcode(s) [70] 13775 0
2324 - Karuah
Recruitment postcode(s) [71] 13776 0
2324 - Seaham
Recruitment postcode(s) [72] 13777 0
2324 - Nelsons Plains
Recruitment postcode(s) [73] 13778 0
2325 - Bellbird
Recruitment postcode(s) [74] 13779 0
2325 - Aberdare
Recruitment postcode(s) [75] 13780 0
2329 - Merriwa
Recruitment postcode(s) [76] 13781 0
2330 - Singleton Heights
Recruitment postcode(s) [77] 13782 0
2333 - Muswellbrook
Recruitment postcode(s) [78] 13783 0
2420 - Dungog
Recruitment postcode(s) [79] 13784 0
2350 - Armidale
Recruitment postcode(s) [80] 13785 0
2347 - Barraba
Recruitment postcode(s) [81] 13786 0
2430 - Cundletown
Recruitment postcode(s) [82] 13787 0
2380 - Gunnedah
Recruitment postcode(s) [83] 13788 0
2352 - Kootingal
Recruitment postcode(s) [84] 13789 0
2346 - Manilla
Recruitment postcode(s) [85] 13790 0
2400 - Moree
Recruitment postcode(s) [86] 13791 0
2390 - Narrabri
Recruitment postcode(s) [87] 13792 0
2430 - Old Bar
Recruitment postcode(s) [88] 13793 0
2430 - Purfleet
Recruitment postcode(s) [89] 13794 0
2343 - Quirindi
Recruitment postcode(s) [90] 13795 0
2340 - Tamworth South
Recruitment postcode(s) [91] 13796 0
2340 - Tamworth
Recruitment postcode(s) [92] 13797 0
2430 - Taree
Recruitment postcode(s) [93] 13798 0
2354 - Walcha
Recruitment postcode(s) [94] 13799 0
2388 - Wee Waa
Recruitment postcode(s) [95] 13800 0
2341 - Werris Creek
Recruitment postcode(s) [96] 13801 0
2340 - Westdale
Recruitment postcode(s) [97] 13802 0
2429 - Wingham
Recruitment postcode(s) [98] 13844 0
2280 - Belmont
Recruitment postcode(s) [99] 13845 0
2280 - Croudace Bay

Funding & Sponsors
Funding source category [1] 294150 0
Government body
Name [1] 294150 0
National Health and Medical Research Council
Country [1] 294150 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] 292980 0
Government body
Name [1] 292980 0
Hunter New England Population Health
Address [1] 292980 0
Locked Bag 10, Wallsend NSW 2287 Australia
Country [1] 292980 0
Australia
Secondary sponsor category [2] 292981 0
University
Name [2] 292981 0
University of Newcastle, School of Medicine and Public Health
Address [2] 292981 0
University Drive
Callaghan NSW 2308
Australia
Country [2] 292981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295560 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 295560 0
Hunter New England Health
Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 295560 0
Australia
Date submitted for ethics approval [1] 295560 0
10/06/2016
Approval date [1] 295560 0
29/06/2016
Ethics approval number [1] 295560 0
15/11/18/4.03

Summary
Brief summary
Changing the scheduling of existing programs in childcare centres may represent an effective strategy which is suitable to ‘scale-up’ for population-wide implementation. Unstructured outdoor free play (as opposed to structured, staff-guided play) has been consistently associated with greater child physical activity.
The study hypothesises that when compared to children attending control services, where continuous indoor/outdoor play is scheduled, children attending intervention services will spend an additional 10 minutes in moderate-to-vigorous physical activity per day at childcare. An increase of 10 minutes of moderate-to-vigorous physical activity in preschool-aged children has been found to have clinically important effects on fat mass and peak bone mass.
Trial website
Trial related presentations / publications
Wolfenden L, Jones J, Parmenter B, et al. Efficacy of a free-play intervention to increase physical activity during childcare: a randomized controlled trial. Health Education Research, 2018, doi:10.1093/her/cyy041
Public notes

Contacts
Principal investigator
Name 67762 0
A/Prof Luke Wolfenden
Address 67762 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 67762 0
Australia
Phone 67762 0
+61 2 49246567
Fax 67762 0
Email 67762 0
[email protected]
Contact person for public queries
Name 67763 0
Ms Jannah Jones
Address 67763 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 67763 0
Australia
Phone 67763 0
+61 2 49246601
Fax 67763 0
Email 67763 0
[email protected]
Contact person for scientific queries
Name 67764 0
A/Prof Luke Wolfenden
Address 67764 0
Hunter New England Population Health
Locked Bag 10
Wallsend, NSW, 2287
Country 67764 0
Australia
Phone 67764 0
+61 2 49246567
Fax 67764 0
Email 67764 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?
Individual participant data collected during the trial after de-identification.
When will data be available (start and end dates)?
On request following publication, no end date determined.
Available to whom?
Determined on a case-by-case basis at the discretion of the investigator team.
Available for what types of analyses?
No specific type - determined on a case-by-case basis at the discretion of the investigator team.
How or where can data be obtained?
On request from the investigator team - email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9985Ethical approval  [email protected]
9986Informed consent form  [email protected]
9987Statistical analysis plan  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Wolfenden, L, Jones J, Parmenter B, et al. Efficac... [More Details]

Documents added automatically
No additional documents have been identified.