Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000854134
Ethics application status
Approved
Date submitted
3/05/2019
Date registered
17/06/2019
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of integrate unstructured play activities into school-based curriculum with mindfulness-based intervention on improving children’s physical, social and emotional wellbeing: A cluster randomized controlled trial
Scientific title
The effectiveness of integrate unstructured play activities into school-based curriculum with mindfulness-based intervention on improving children’s physical, social and emotional wellbeing: A cluster randomized controlled trial
Secondary ID [1] 298038 0
Nil
Universal Trial Number (UTN)
u1111-1232-1432
Trial acronym
Supporting Wellness in Early Learning Environments (SWELE)
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 312496 0
Sedentary behaviors 312497 0
anxiety 312498 0
emotional wellbeing 312499 0
Condition category
Condition code
Public Health 311042 311042 0 0
Health promotion/education
Diet and Nutrition 311043 311043 0 0
Obesity
Mental Health 311044 311044 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Unstructured /free/loose parts of play with mindfulness-based intervention will used outdoor play materials e.g. leaves, sand, ropes, sticks, branches, water, boxes
SWELE is a 12-week program focusing on children’s physical, mental and social well-being as they transition from preschool to kindergarten to primary school. The SWELE program consists of daily opportunity to 1) engage in self-directed, loose parts unstructured, active play, us materials provided on the school playground (45-60 minutes); 2) participate in a mindfulness-based intervention with storytelling, art activities on ‘body scan’ and ‘breathing techniques’ (15 minutes). Three-time point measures will assess child's physical health status and physical activity, emotional well-being, social competency, and playfulness. A mental health nurse and trainers deliver mindfulness intervention sessions. The mode of mindfulness-based intervention is story-telling to the whole class after the unstructured play activity. Class attendance log book will be used to assess and monitor adherence of the intervention.
Intervention code [1] 314349 0
Behaviour
Intervention code [2] 314350 0
Prevention
Comparator / control treatment
The 'play as usual' for the comparison group is the preschoolers in the kindergarten will continue their indoor structural play as the routine.
Control group
Active

Outcomes
Primary outcome [1] 319934 0
1. Measuring kindergarten children’s physical status and physical activity level by body mass index and electric pedometer respectively,
Timepoint [1] 319934 0
There are three time points: T0 (baseline)- before the implementation of SWELE program, T1 (Mid-point) - at the 6th week of the SWELE program and T2 (Post-test)-immediate after the 12-week of the SWELE program completed.
Primary outcome [2] 320232 0
2. Measure kindergarten children’s social engagement by the Penn Interactive Peer Scale and Test of Playfulness Scale
Timepoint [2] 320232 0
There are three time points: T0 (baseline)- before the implementation of SWELE program, T1 (Mid-point) - at the 6th week of the SWELE program and T2 (Post-test)-immediate after the 12-week of the SWELE program completed.
Primary outcome [3] 320234 0
3. Measure kindergarten children’s emotional wellbeing and anxiety level by Children's Emotional Manifestation Scale and Picture Anxiety Test respectively.
Timepoint [3] 320234 0
There are three time points: T0 (baseline)- before the implementation of SWELE program, T1 (Mid-point) - at the 6th week of the SWELE program and T2 (Post-test)-immediate after the 12-week of the SWELE program completed.
Secondary outcome [1] 369926 0
The outcome of focus group discussions among preschoolers, school teachers, school principals and parents in the intervention by conducting with a semi-structural interview guide is to measure the acceptability of the SWELE program by the target participants and the stakeholders.
Timepoint [1] 369926 0
At T2 (Post-test)-immediate after the 12-week of the SWELE program completed.
Secondary outcome [2] 371258 0
Measure kindergarten children’s happiness by the 5 Smiley Face Happiness Scale
Timepoint [2] 371258 0
There are three time points: T0 (baseline)- before the implementation of SWELE program, T1 (Mid-point) - at the 6th week of the SWELE program and T2 (Post-test)-immediate after the 12-week of the SWELE program completed.

Eligibility
Key inclusion criteria
The inclusion criteria for the recruitment of kindergarten children for this study are 1) children aged between 4-7 years old studying in selected kindergartens (K2), and their school teachers, school principals and parents in the kindergarten; 2) children are free from physical impairment and cardiovascular disease based on their school medical records; and 3) children can follow instructions and understand the mindfulness teaching materials as presented by school teachers/school counsellor and parents.
Minimum age
3 Years
Maximum age
66 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

The exclusion criteria are: 1) children aged over 6 and under 4 years old and not studying in either of the kindergartens; 2) children have physical impairment or are diagnosed with cardiovascular diseases according to school medical records; and 3) children have extreme difficulty comprehending, memorising, and visualising the instructions from mindfulness teaching materials.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This study will use it to stage mixed method design to investigate the feasibility and acceptability of the pilot program. A mixed methods approach with a randomized controlled trial with pre- test, mid-point and post-tests measurement and four focus group discussions. There are two phases -: first phase is an quantitative study and the second phase is the qualitative study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM SPSS 22 will be used for data analysis. The significance level will be set at 0.05. In the multilevel mixed model, the fixed effects will be Group, Time, and Group by Time. The calculation of df will be based on residual method. The covariance type of random intercepts among schools will be specified as diagonal. The covariance type of repeated measures will be specified as first order autoregressive. Robust covariance estimator will be used. Normality of scale outcomes such as SFL, PAT, PIPPS, and Pedometer readings will be checked by using Q-Q plots, then corresponding distribution and link function will be specified in SPSS. Demographics were considered as covariates in the general linear, ordinal regression and binary logistic regression models, analysing the relationship between the SWELE and the outcome variables. Outcome variables that followed normal distributions were analysed in the general linear model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
29/03/2021
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment outside Australia
Country [1] 21449 0
Hong Kong
State/province [1] 21449 0

Funding & Sponsors
Funding source category [1] 302563 0
Other Collaborative groups
Name [1] 302563 0
Hong Kong School Nurses Association
Country [1] 302563 0
Hong Kong
Primary sponsor type
Other Collaborative groups
Name
Hong Kong School Nurses Association
Address
28 Siu Sai Wan Road, Siu Sai Wan, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 302588 0
None
Name [1] 302588 0
None
Address [1] 302588 0
None
Country [1] 302588 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303208 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 303208 0
Callaghan, University Drive
NSW 2308
Australia
Ethics committee country [1] 303208 0
Australia
Date submitted for ethics approval [1] 303208 0
12/02/2018
Approval date [1] 303208 0
26/03/2019
Ethics approval number [1] 303208 0
H-2018-0335

Summary
Brief summary
Play is a complex and crucial aspect of early physical, social and emotional development. Importantly, evidence suggests that unstructured outdoor play facilitates children’s executive function, increases social skills and physical activity, and reduces childhood obesity, bullying and mental health problems. Opportunities for outdoor unstructured play are increasingly limited putting at risk these benefits. Mindfulness training may help children deal with anxiety and mental-health difficulties, and it has been adopted as a preventive measure in some mainstream primary school settings. While promising, there is no conclusive evidence of the effects of mindfulness-based intervention in children’s psycho-social wellbeing.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92854 0
Prof Regina LT Lee
Address 92854 0
The University of Newcastle
Faculty of Medicine and Health
Callaghan, University Drive, New South Wales
2308 Australia
Country 92854 0
Australia
Phone 92854 0
+61 2 49215768
Fax 92854 0
Email 92854 0
[email protected]
Contact person for public queries
Name 92855 0
Prof Regina LT Lee
Address 92855 0
The University of Newcastle
Faculty of Medicine and Health
School of Nursing and Midwifery
Callaghan, University Drive
New South Wales
2308 Australia
Country 92855 0
Australia
Phone 92855 0
+61 2 49215768
Fax 92855 0
Email 92855 0
[email protected]
Contact person for scientific queries
Name 92856 0
Prof Regina LT Lee
Address 92856 0
The University of Newcastle
Faculty of Medicine and Health
Callaghan, University Drive, New South Wales
2308 Australia
Country 92856 0
Australia
Phone 92856 0
+61 2 49215768
Fax 92856 0
Email 92856 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1986Ethical approval    377449-(Uploaded-03-05-2019-05-37-14)-Study-related document.pdf



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.