Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000754549
Ethics application status
Approved
Date submitted
28/05/2024
Date registered
18/06/2024
Date last updated
18/06/2024
Date data sharing statement initially provided
18/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility and preliminary efficacy of a physical activity programme in New Zealand Early Childhood Education: A pilot cluster-randomized controlled trial
Scientific title
The feasibility and preliminary efficacy of a physical activity programme in New Zealand Early Childhood Education: A pilot cluster-randomized controlled trial
Secondary ID [1] 312216 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 333895 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330679 330679 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot cluster-randomised controlled trial was carried out within early childhood education (ECE) centres in Hawkes Bay, two intervention and two control in order to determine feasibility and preliminary efficacy of online physical activity programme movement-active-physical-play (M.A.P.P). Total number of participants included four ECE centres, four centre managers, four head teachers, 20 early childhood (EC) teachers and 46 children three to five years old. An invitation via direct email to ECE centres was extended, recruitment continued until the required sample volunteered to participate, Randomisation took place (using Microsoft Excel randomisation function) immediately following baseline data collection, two allocated to M.A.P.P and two to control group who will continue with usual practice physical activity delivery. Assessments were carried out at baseline and post intervention period (~10 weeks post-baseline, post-completion of intervention). To measure moderate-to-vigorous-physical-activity (MVPA) participants had a wrist worn accelerometer that was fitted by EC teachers at the beginning of the day (9am) and removed at the end of the day (3pm) for five days at baseline and again at follow-up 10-weeks later.
The M.A.P.P programme and teaching resource was developed by the primary author following over twenty years’ experience working alongside children, their families, EC teachers and ECE centres unpacking the role that movement and nature play in child development. M.A.P.P was further refined by two ECE centres who piloted (three weeks) and provided feedback on the final version of the programme prior to trial start date. EC teachers received a M.A.P.P pack of resources, including an Ipad with the online M.A.P.P programme and teaching resource, a written M.A.P.P resource was also provided one week prior to trial start date . This is made up of seven narrated webinars and associated readings, 40 activity videos and programme implementation guide to deliver the intervention 15-minutes per day, five days per week across the 10-week timeframe. Narrated webinars and readings are aligned to the New Zealand early childhood curriculum Te Whariki pedagogical principles and strands. The four components of M.A.P.P each have an associated character with specific active play characteristics, Movement Max, Active Ann, Physical Piri and Playful Pip. Each character has their own action song that was developed to enable EC teachers to recognise, integrate and facilitate a well-balanced movement programme during the childcare day. The M.A.P.P implementation guide for EC teachers comprised of a five-day week, Monday was Movement Max activities and action song, Tuesday Active Ann, Wednesday Physical Piri, Thursday Playful Pip, and Friday a combination of all activities with a focus on what children enjoyed the most. Providing a physical activity map for EC teachers to follow. As such, EC teachers were encouraged to take an active teaching role in the delivery of the M.A.P.P activities however, pre-recorded activity videos were available to support all ability accessibility EC teacher delivery.
The M.A.P.P online teaching resource is made up of narrated webinars, readings, activity videos and implementation guide to enable EC teachers to view at a time that best suits them. The professional learning is over 10-weeks, self-paced and designed to be completed during work hours when EC teachers are not teaching (non-contact time) and to take no longer than 30 minutes. Each week EC teachers are encouraged to watch one webinar, engage in the prescribed reading, and implement their new knowledge with children during the childcare day. Each webinar and reading builds knowledge on the last, scaffolding learning for EC teachers so they can prioritise child interest in intentional planning, spontaneous active play, and environmental provocations for physical activity. Activities are designed to be completed in a flexible fashion to ensure that it is not a barrier to action. Each M.A.P.P activity is pre-recorded, with a combination of children of different ages, ethnicities, either individually or in a group. There is a level of predictability and routine in each session with a warm-up of high energy music encouraging children to participate and a cool down of walking with hand on heart to feel heartbeat and an opportunity for EC teachers to implement cross-curricular links and discuss with children their body’s reaction to physical activity and the importance of drinking water after exercise. Typically, EC teachers hold a high trust relationship with children in their ECE centre therefore children are physically comfortable and emotionally secure to explore and try new things.
M.A.P.P Professional Learning programme week one
Week 1: Physical activity in ECE
Monday: Narrated webinar and associated reading, Movement Max action song, Activity video
Tuesday: Activity video, Active Ann action song
Wednesday: Activity video, Physical Piri action song
Thursday: Activity video, Playful Pip action song
Friday: Favourite M.A.P.P activities and action song of the week

M.A.P.P Monday activity week one: Physical activity in ECE, (see video week 1)
M.A.P.P Motivator/ (Active Teacher Role): Actively support/ invite children to session/ role model activity
Warm- Up: High energy music and movement (3-5 minutes)
Skill Session: Monday, Movement Max action song
Activity: Bear Walk, have children on the floor on their hands and knees, encourage them to lift both knees off the floor, they are now in bear walk position, repeat Have children in bear walk position and encourage them to move forwards, moving right hand and left leg (opposition movement), do this slowly, repeat other side. Co-construct a bear walking/ running track.
Warm-Down: Walk for 10 steps, feel your heart and tummy for 10 beats, walk for 10 steps repeat as often as the children are wanting to participate.
NUMBER OF TIMES FOR INTERVENTION DELIVERY
Over 10-weeks, 15-minute M.A.P.P activity sessions, four days per week were delivered by EC teachers.
LOCATION
All M.A.P.P sessions were delivered in ECE centres during the childcare day. The professional development component of the programme was designed to be carried out during the day in EC teacher non-contact time with a M.A.P.P module to be completed and implemented each week. The M.A.P.P sessions were delivered by EC teachers to children during the childcare day.
ADHERENCE
Was assessed via recording of M.A.P.P activity sessions delivered by EC teachers.
Intervention code [1] 328662 0
Lifestyle
Comparator / control treatment
Usual physical activity delivery in an ECE centre. Given that each ECE centre has a unique approach and varying environment to meeting physical activity delivery the usual physical activity programme control groups will inevitably be somewhat varied, but the intervention is to compare relative efficacy of M.A.P.P with current programme as it is. Normal physical activity within an ECE centre is made up of planned and unplanned experiences and activities subject to individual centre curriculum priorities and individual EC teacher determination.
Control group
Active

Outcomes
Primary outcome [1] 338330 0
The primary trial outcome is the total mean/ minutes per day that children spend in MVPA during the childcare day.
Timepoint [1] 338330 0
Assessed for five days at baseline and for five days at follow-up (~10 weeks post-baseline, post-completion of intervention)
Secondary outcome [1] 435451 0
A secondary trial outcome is the total mean/ minutes per day that children spend in light physical activity during the childcare day.
Timepoint [1] 435451 0
Assessed for five days at baseline and for five days at follow-up (~10-weeks post-baseline, post-completion of intervention).
Secondary outcome [2] 435452 0
Quality of the movement environment in ECE centres
Timepoint [2] 435452 0
Baseline and follow-up (~10 weeks post-baseline, post-completion of intervention)
Secondary outcome [3] 435453 0
In order to specifically address acceptability of the intervention semi-structured interviews were carried out with EC leaders, such as managers or head teachers and EC teachers. The 'child voice' was heard through semi-structured group interviews with children. These discussions were semi-structured with a casual approach to ensure the discussion is more engaging for this age group. The main focus of these discussions is to enable participants to express their views on M.A.P.P, what they did or did not enjoy and would they continue to use the programme.
Group and individual interviews with EC leaders and EC teachers were carried out post-intervention at the ECE centre at a time that was suitable for them. These discussions determined their experiences with M.A.P.P professional learning and activity delivery, and to solicit reflective feedback on possible future implementation and sustainability of the M.A.P.P programme in their ECE centre.
Timepoint [3] 435453 0
Post-completion of intervention - (~ten weeks).
Secondary outcome [4] 435958 0
A secondary trial outcome is the total mean/ minutes per day that children spend in moderate physical activity during the childcare day.
Timepoint [4] 435958 0
Assessed for five days at baseline and for five days at follow-up (~10 weeks post-baseline, post-completion of intervention).
Secondary outcome [5] 435960 0
A secondary trial outcome is the total mean/ minutes per day that children spend in vigorous physical activity during the childcare day.
Timepoint [5] 435960 0
Assessed for five days at baseline and for five days at follow-up (~10 weeks post-baseline, post-completion of intervention).
Secondary outcome [6] 435961 0
A secondary trial outcome is the total mean/ minutes per day that children spend in sedentary behaviour during the childcare day.
Timepoint [6] 435961 0
Assessed for five days at baseline and for five days at follow-up (~10 weeks post-baseline, post-completion of intervention).

Eligibility
Key inclusion criteria
Children 3 - 5 years enrolled at licensed early Early Childhood Education centres
Qualified and either fully or provisionally registered Early Childhood Teachers
Ministry of Education licensed Early Childhood Education centres in Hawkes Bay
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to participate in normal physical activity within an Early Childhood Education centre
Early Childhood Teachers who are not qualified or registered (either fully or provisionally)
Early Childhood Education centres in Hawkes Bay who are not Ministry of Education licensed

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was conducted post baseline assessment by Microsoft Excel randomisation function
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Intervention effects were quantified using (generalised) linear mixed models to assess adjusted effects of the intervention on outcome measures at completion. Visual inspection to check uniform variance and normal distribution of residuals occurred (where necessary, data will be transformed, or nonparametric alternatives utilised). The fixed effect is the group (intervention or control), and the dependent variable is the post-intervention outcomes variables (time spent in MVPA). Model covariates are sex, age, and baseline value of the outcome to adjust for any imbalances between the intervention and control groups at baseline.
Data are expressed as mean ± SD, with uncertainty in all estimates expressed as 95% confidence intervals (CI). Cohen's d effect sizes were derived.
Data are presented in the form of component (each question, subscale) and composite (MOVERS) scores.
Semi-structured interviews were audio recorded and transcribed verbatim with each transcript read several times by the first author. Analysis first began after the first period of data collection by segmenting the data and coding it to allow specific codes and themes to emerge that were based upon study aims.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2022
Date of last participant enrolment
Anticipated
Actual
20/06/2022
Date of last data collection
Anticipated
Actual
30/11/2022
Sample size
Target
112
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 26347 0
New Zealand
State/province [1] 26347 0
Hawkes Bay

Funding & Sponsors
Funding source category [1] 316613 0
University
Name [1] 316613 0
Auckland University of Technology
Country [1] 316613 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Royston Health Trust
Address
Country
New Zealand
Secondary sponsor category [1] 318772 0
Other Collaborative groups
Name [1] 318772 0
Hawkes Community Fitness Centre Trust
Address [1] 318772 0
Country [1] 318772 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315377 0
Auckland University of Technology Ethics Committee
Ethics committee address [1] 315377 0
Ethics committee country [1] 315377 0
New Zealand
Date submitted for ethics approval [1] 315377 0
25/02/2022
Approval date [1] 315377 0
12/04/2022
Ethics approval number [1] 315377 0

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

Contacts
Principal investigator
Name 134514 0
Mrs Wendy Pirie
Address 134514 0
Auckland University of Technology, 55 Wellesley Street East, Auckland Central, 1010
Country 134514 0
New Zealand
Phone 134514 0
+64 0273296776
Fax 134514 0
Email 134514 0
wendy@freshairforests.co.nz
Contact person for public queries
Name 134515 0
Wendy Pirie
Address 134515 0
Auckland University of Technology, 55 Wellesley Street East, Auckland Central, 1010
Country 134515 0
New Zealand
Phone 134515 0
+64 0273296776
Fax 134515 0
Email 134515 0
wendy@freshairforests.co.nz
Contact person for scientific queries
Name 134516 0
Wendy Pirie
Address 134516 0
Auckland University of Technology, 55 Wellesley Street East, Auckland Central, 1010
Country 134516 0
New Zealand
Phone 134516 0
+64 0273296776
Fax 134516 0
Email 134516 0
wendy@freshairforests.co.nz

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.