Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000198628
Ethics application status
Approved
Date submitted
25/11/2022
Date registered
23/02/2023
Date last updated
23/02/2023
Date data sharing statement initially provided
23/02/2023
Date results provided
23/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of an e-newsletter or animated video to disseminate outdoor free-play information in relation to COVID-19 Guidelines in New South Wales Early Childhood Education and Care services: a randomised controlled trial.
Scientific title
The impact of an e-newsletter or animated video to disseminate outdoor free-play information in relation to COVID-19 Guidelines in New South Wales Early Childhood Education and Care services: a randomised controlled trial.
Secondary ID [1] 308499 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 328312 0
Condition category
Condition code
Public Health 325356 325356 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early Childhood and Education Centres (ECEC) were randomly allocated to one of three arms: i) e-newsletter group; ii) animated video group; or iii) control group. All participants received an email containing links to the COVID-19 specific Guidelines for New South Wales (NSW) ECEC services released by the NSW Department of Education. For both intervention groups, an additional link to either the e-newsletter or animated video was embedded within the email.
The intervention resources focused on addressing key barriers associated with Guideline adoption within the ECEC setting. Both intervention resources addressed the same barriers to Guideline adoption, however the animated video resource, a novel approach to delivering guideline information, was developed to elicit an emotional reaction through the inclusion of audio and visual elements, including a visual demonstration of the behaviour.
Barriers to guideline adoption that were targeted in the intervention were; i) lack of awareness of the guidelines, ii) lack of knowledge and understanding of the guidelines, iii) lack of understanding regarding the benefits of the guidelines, iv) lack of belief they are capable of adopting the guidelines and v) lack of priority in adopting the guidelines. Strategies used tom address these barriers were; i) using language ECEC educators can relate to and understand, ii) highlight how the guidelines apply to ECEC services, iii) promoting the benefits of the guidelines, iv) using language that is strength-based and action focused and providing examples to facilitate adoption, v) highlight the source of the guidelines and the benefits in relation to COVID-19 risk.

The e-newsletter was approximately 2 pages of text, requiring an estimated 2-3 minutes to read and was provided to participants as a link within an email so participants could open the link more than once if they desired. Unique views of the e-newsletter were captured which equates to views from a unique device. Additionally average view duration was calculated, along with percent of the e-newsletter read and proportion of viewers that read in-depth the e-newsletter. These analytics are available through the Microsoft platform that the e-newsletter was housed on.

The animated video duration is 3 minutes 28 seconds and was provided to participants as a link within an email so participants could open the link more than once if they desired. Unique views for the animated video were captured which equates to views for 30 seconds or more. Additionally average view duration was calculated, along with percent of the animated video watched and proportion of viewers that watched the entire video. These analytics are available through YouTube.
Intervention code [1] 324931 0
Behaviour
Intervention code [2] 324932 0
Prevention
Comparator / control treatment
ECEC services allocated to the control group received a generic email outlining the published COVID-19 specific Guidelines and a link to the NSW Department of Education website. The intervention groups email did not list all the Guidelines however included another link to the intervention resource.

Specifically, the COVID-19 Guidelines recommended were:
i) Whenever possible (weather dependent) and when you have enough staffing for adequate supervision, consider operating an indoor/outdoor program for the full day/session. This naturally provides for more space for the children and the setup of more activities for children to engage in.
ii) If you are not able to run an indoor/outdoor program, consider spending more time outdoors, consider the placement of activities and the amount of activities in the outdoor space. A greater range of activities will encourage children to spread out more broadly.
iii) Sharing of food should be actively monitored and discouraged.
iv) Staff should serve children and avoid allowing children to self-serve from a shared plate.
v) Look at your setup when children are eating. Consider having less children at each table and use more tables to allow more space between children.
vi) If you have limited tables and normally have all children eating at the same time, consider staggered timings of snacks and lunch over a longer period of time.

The control email was slightly longer than the intervention groups email (282 words, and the intervention groups email was 124 words). Open analytic rates were not recorded for the control group.
Control group
Active

Outcomes
Primary outcome [1] 333213 0
The primary trial outcome was the proportion of services intending to adopt the Guidelines. Services were defined as intending to adopt the Guidelines if they reported having intentions to; (i) offer an indoor-outdoor program for the full day; or (ii) offer more outdoor play time, as services unable to offer an indoor-outdoor program may still plan on offering more outdoor play time during the ECEC day. This outcome was reported by the ECEC Service's Nominated Supervisor, or delegate, via an online or telephone survey.
Timepoint [1] 333213 0
Outcomes were assessed post-intervention only, between October and December 2021 (within 3 months following the distribution of the intervention dissemination strategies).
Secondary outcome [1] 416187 0
Awareness of the Guidelines reported by the ECEC Service's Nominated Supervisor, or delegate, via an online or telephone survey, designed specifically for this study.
Timepoint [1] 416187 0
Awareness outcomes were assessed post-intervention only, between October and December 2021 (within 3 months following the distribution of the intervention dissemination strategies).
Secondary outcome [2] 416188 0
Knowledge of the Guidelines reported by the ECEC Service's Nominated Supervisor, or delegate, via an online or telephone survey, designed specifically for this study.
Timepoint [2] 416188 0
Outcomes were assessed post-intervention only, between October and December 2021 (within 3 months following the distribution of the intervention dissemination strategies).
Secondary outcome [3] 416189 0
Implementation of the Guidelines i.e. indoor-outdoor programs for the full day and/or offering all free play outdoors reported by the ECEC Service's Nominated Supervisor, or delegate, via an online or telephone survey, designed specifically for this study.
Timepoint [3] 416189 0
Outcomes were assessed post-intervention only, between October and December 2021 (within 3 months following the distribution of the intervention dissemination strategies).
Secondary outcome [4] 417355 0
Reach of the intervention strategies via data analytics from Microsoft Office Sway (e-newsletter) and YouTube (animated video). Analytics included total number of views, link clicks and length of views.
Timepoint [4] 417355 0
Outcomes were assessed post-intervention only, between October and December 2021 (within 3 months following the distribution of the intervention dissemination strategies).

Eligibility
Key inclusion criteria
ECEC services located in NSW, publicly available through the National register (Australian Children’s Education & Care Quality Authority (ACECQA)).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Services were removed from the sample if they were: 1) not listed as either a preschool or long day care service (e.g. family day care service, or before and after school care); 2) listed as a Department of Education service; 3) temporarily closed; 4) located outside of the state of NSW; or 5) were concurrently selected to participate in a nationwide survey being conducted by the research team. ECEC services located within the Hunter New England Local Health District of NSW were also excluded from the current randomised controlled trial, as they were already participating in a separate intervention to improve outdoor free play.

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)
Randomisation was conducted by a blinded research statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number function in Microsoft excel in a 1:1:1 ratio.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis was undertaken using SAS version 9.3 by a blinded statistician. Analyses were performed on services that completed the post-intervention follow-up survey, with ECEC services as the unit of analysis. Descriptive statistics were used to describe service demographics and Nominated Supervisor characteristics of the sample.
Intervention effects on the primary trial outcome were assessed using separate logistic regression analyses to examine differences in Guideline adoption (e-newsletter vs animated video; e-newsletter vs control; animated video vs control), controlled for service size, location/remoteness, and date of survey completion.
Dichotomous secondary outcomes (awareness, knowledge and implementation of the Guideline) were assessed using separate logistic regression analyses similar to the primary outcome.

Differences between the three arms were assessed through linear regression models, controlled for service size, location/remoteness, and date of survey completion.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/10/2021
Date of last participant enrolment
Anticipated
Actual
21/12/2021
Date of last data collection
Anticipated
Actual
21/12/2021
Sample size
Target
713
Accrual to date
Final
154
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312741 0
Government body
Name [1] 312741 0
National Health and Medical Research Council (NHMRC)
Country [1] 312741 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
HNE Population Health
Booth Building, Longworth Avenue
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 314362 0
None
Name [1] 314362 0
Address [1] 314362 0
Country [1] 314362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312036 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 312036 0
Ethics committee country [1] 312036 0
Australia
Date submitted for ethics approval [1] 312036 0
Approval date [1] 312036 0
10/09/2021
Ethics approval number [1] 312036 0
2019/ETH12353

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

Contacts
Principal investigator
Name 123262 0
Dr Kathryn Reilly
Address 123262 0
Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton NSW 2305
Country 123262 0
Australia
Phone 123262 0
+61412591777
Fax 123262 0
Email 123262 0
[email protected]
Contact person for public queries
Name 123263 0
Kathryn Reilly
Address 123263 0
Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton NSW 2305
Country 123263 0
Australia
Phone 123263 0
+61412591777
Fax 123263 0
Email 123263 0
[email protected]
Contact person for scientific queries
Name 123264 0
Kathryn Reilly
Address 123264 0
Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton NSW 2305
Country 123264 0
Australia
Phone 123264 0
+61412591777
Fax 123264 0
Email 123264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.