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Trial registered on ANZCTR


Registration number
ACTRN12619001320145p
Ethics application status
Not yet submitted
Date submitted
5/09/2019
Date registered
27/09/2019
Date last updated
27/09/2019
Date data sharing statement initially provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How does a Movement Oriented Games Based Assessment (MOGBA) programme impact upon the movement competence, physical activity levels and self-perceptions of children aged 8-12 years of age?
Scientific title
How does a Movement Oriented Games Based Assessment (MOGBA) programme impact upon the movement competence, physical activity levels, physical fitness and self-perceptions of children aged 8-12 years of age?
Secondary ID [1] 299094 0
Nil
Universal Trial Number (UTN)
Trial acronym
MOGBA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 314134 0
movement deficiency 314135 0
exercise motivation 314137 0
Condition category
Condition code
Mental Health 312509 312509 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 312510 312510 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The delivery of a 9 week MOGBA programme of activities, delivered by the research team (PhD and post-doctoral level) to groups of approx. 20-30 children, aged 8-12 years, in educational settings across four countries (Australia, Ireland, England and USA).

Intervention involves:

1. Coach learning session
A three hour mixture of theory and practical content involving, designed by the Principle Investigator and lead investigator from each of the clusters (cluster lead) and then delivered by each cluster lead, in-country, to two coaches. The format of the coach learning session will be: (i) the nature of children's movement development, (ii) Rationale, structure and purpose of MOGBA, (iii) Intervention programme of activities, (iv) changing the challenge, (v) differentiating opportunities (vi) assessing and recording movement competence and (vii) using assessment to guide teaching and improve movement competence

2. MOGBA delivery
At each cluster, all 14 MOGBA activities, ranging in categories (Stability (S), Object Control (OC) and Locomotion (L)) and complexity of movement (across three phases) will be delivered, with two sessions each week over a 9 week period with each session lasting between 45-60 minutes. One MOGBA activity will last the duration of the session. An extra four sessions have been accounted for within the intervention period to cater for typical disruptions to timetables.

The MOGBA activities are:
Phase 1: 'Space Invaders 1 (2v1)' (OC), 'T-Time' (S), 'Square Ball' (OC) and 'Raid' (L).
Phase 2: 'Space Invaders 2 (3v2) (OC), 'Cornerball' (OC), 'End Zone 1' (S), Kabbadi (S), 'Gateways' (L) and 'Potted Skills Circuit' (L)
Phase 3: 'Space Invaders 3 (3v4)' (OC), 'Mat Rounders' (OC), 'End zone 2' (S) and 'Tag' (L)

The MOGBA activities are presented as a series of resource cards with the front of the card illustrating the game as well as sections describing 'what you need' (equipment), 'set up like this', 'keep it safe' and 'change the game'. On the reverse of the card, there is an assessment framework that illustrates the movement being assessed and provides criteria for the practitioner to use to score the child's performance 1, 2 or 3, based on initial, developing and mature patterns of movement. The assessment contained on this card has two focal aspects of assessment (i.e. head and legs) and is viewed as an 'initial assessment', which might be used by practitioners with limited experience of movement assessment.

The resource also contains an 'introductory section' that explains the nature of children's movement development and the purpose of MOGBA, as well as sections on 'complete assessment' and 'change the challenge'. The 'complete assessment' uses the same scoring method as the initial assessment, with an additional two focal points for the assessment (i.e. head, arms, legs and body) to the initial assessment. 'Change the challenge' provides guidance for practitioners on how to differentiate the activity to meet the diverse needs of children in relation to Gallahue, Osmun & Goodway's (2012) notion of Space, Effort and Relationships.

3. Coach mentoring:
Each cluster lead will act as mentors by observing and providing feedback to the coaches delivering MOGBA for the first 3 weeks of the program (3 x 30minutes during the coaches programmed 45-60 minute session). The observation and feedback will be framed by the fidelity observational measure. Mentoring ensures the coaches involved understand the format and purpose of the designed content, and for coaches to observe, undertake, problem solve and trouble shoot more effective practice with an academic partner, in the authentic context of their own coaching sessions.

Sample
Coaches (n=2) will be trained to deliver MOGBA in each cluster across both randomised intervention and wait-list control groups. Each cluster will contain 8 schools (4 intervention and 4 wait-list control) with each school providing one class of children (n=30) for each of the age ranges (age=7/8 years, 8/9 years, 10/11 years, 11/12 years).

Fidelity and adherence
All coaches (intervention and control) are observed by a trained assessor at Weeks 3 and 7 of the 9-week intervention, with sessions referenced against content indicators. Sessions are judged by adherence to (1) set-up criteria (2) play the game (3) change the challenge, and (4) assessment of movement, to obtain the percentage of agreement for each of these sets of statements (E.g. lesson agreement with one of four activity based statements = 25% activity agreement). These agreement values are used to indicate: i) if activity delivery at each time point was in line with a movement-based approach, and ii) if the fidelity of the instruction undertaken by the intervention group teachers was in line with the true nature of the intervention.

A register of attendance at learning sessions for coaches and at activity sessions for children is maintained to monitor adherence at sessions across the intervention period.
Intervention code [1] 315361 0
Behaviour
Intervention code [2] 315362 0
Lifestyle
Intervention code [3] 315363 0
Treatment: Other
Comparator / control treatment
Standard treatment wait-list control group.
The wait-list control group undertake the standard content planned by their teachers across the intervention period. This content will vary from country to country and will also be subject to change based on the seasonality of delivery across the RCT. All countries will follow some sort of Physical Education curriculum, whether that be determined at national, provincial or regional level. Teachers from the wait-list control groups will receive a professional development intervention and the MOGBA resource after the completion of follow-up assessments (6 months post-intervention).
Control group
Active

Outcomes
Primary outcome [1] 321141 0
Children's Specialised Movement Skills as a result of exposure to a MOGBA program, specifically created for this study (MOGBA has not been validated) through observation of children's movement competence using 'Dragon Challenge'.
Timepoint [1] 321141 0
Baseline, 10 weeks from delivery of first session and six months from baseline
Secondary outcome [1] 374121 0
Children's physical activity using accelerometers (Actigraph, wrist worn) used to assess Moderate to Vigorous Physical Activity
Timepoint [1] 374121 0
Baseline, 10 weeks and 6 months from baseline
Secondary outcome [2] 374122 0
Children's physical self-perception using Harter's (1982) scales
Timepoint [2] 374122 0
Baseline, 10 weeks and 6 months from baseline
Secondary outcome [3] 374123 0
A composite secondary outcome of children's physical fitness, measured using a standing long jump, plank and height and weight.
Standing long jump will be assessed by following the guidance provided in the Assessment of Physical Activity (ALPHA, 2009) manual. Equipment used by the assessor will be: Non-slippery hard surface, stick, tape measure, adhesive tape, and cones. The assessor will mark a start line on a floor with tape and draw horizontal lines on the landing region 10 cm apart, parallel to and starting 1 m from the take-off line. A tape measure perpendicular to these lines gives accurate measurements. The assessor will then ask the participant to "Stand with your feet at the shoulder’s width, and toes just behind the line. Bend your knees with your arms in front of you, parallel to the ground. As you swing both arms, push off vigorously and jump as far as possible. Try to land with your feet together and to stay upright". The assessor will then demonstrate the test to the participants. An assessor will use a measuring tape to measure the distance from the taped line to the rear most part of the participant's rear foot. The participant must land upright and can be given an additional attempt if they fall backwards. The test will be repeated twice with the best score registered as the test score for standing long jump.

The plank protocol requires participants to maintain a static prone position with only forearms and toes touching the ground. Participants will be asked to keep their feet together with toes curled under the feet, elbows forearm distance apart, and hands clasped together against the floor mat. Participants will be asked to maintain eye contact with their hands, a neutral spine, and a straight line from head to ankles. The child will be given one 5-s practice trial, during which the examiner will instruct the child to adopt the proper position, followed by a 25-s period of rest. The test will begin when the participant demonstrates the correct position; a stopwatch will be started. Participants will be allowed to deviate from the correct position once and can continue the test if they immediately resume the correct starting position. The test will be terminated on the second deviation from the correct position or if the participant did not return to the correct position after the first warning; stopwatch will be stopped and the time taken on the test will be recorded as the test score for the plank.
Height and weight will be measured with participants barefoot and in physical education clothes. Weight will be measured with an electronic scale (Type OMRON BF400, Kyoto, Japan). Height will be assessed using a Leicester Height Measure (Type Seca; Birmingham, UK; range 14 to 207 cm). Instruments will be calibrated to ensure accurate measures. Additionally, sitting height will be assessed with the participant sitting on the box with his or her back and buttocks to the backboard of the stadiometer, and with his or her head in the Franckfort horizontal plane (Castro-Pinero et al., 2014).
Timepoint [3] 374123 0
Baseline, 10 weeks and 6 months from baseline
Secondary outcome [4] 374600 0
Game self-perception using Miller's (2019) scales
Timepoint [4] 374600 0
Baseline, 10 weeks and 6 months from baseline
Secondary outcome [5] 374601 0
Children's enjoyment using a 3 scale process measure (emoji icons- ranging from happy/sad), created specifically for this study
Timepoint [5] 374601 0
Baseline, 10 weeks and 6 months from baseline
Secondary outcome [6] 375276 0
Children's physical activity using accelerometers (Actigraph, wrist worn) used to assess time spent sedentary.
Timepoint [6] 375276 0
Baseline, 10 weeks and 6 months from baseline

Eligibility
Key inclusion criteria
Coach:
Experience (min 20 hours) of coaching children (8-12 years) in a sport setting
Level 1 coaching qualification in a game (e.g. soccer, hockey)

School:
State schools providing education for children within the age ranges 8-12 years, able to provide space for physical activity (indoors and outdoors)

Children:
Aged 8-12 years, educated within a state school
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Coach:
Undergraduate degree in a sport-related field (e.g. Physical Education, sport coaching, sport development)
Level 2, or higher, coaching qualification in a game (e.g. soccer, hockey)

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)
Schools allocated to intervention or wait-list control. Allocation is decided post baseline assessment, with participants informed of group enrolment prior to intervention start. All children within a class will participate.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation used to select schools from register of intent to participate, using computer software to randomly generate the sequence of selection
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model

Without accounting for clustering among schools (schools being alike and reducing the power of data), approximately 156 students are required to detect an effect of d = 0.4 at 80% power with alpha 0.05. To adjust for clustering, the following correction factor is applied [1+ (m – 1) x ICC] (Donner & Klar, 2000), where m = students per school and ICC = the intra-class correlation coefficient (between school variance / (between school variance + within school variance). Assumptions are based on clustering at the school level (two classes recruited per school, with 25 students per class = 50 per cluster), and an ICC of 0.12 based on data from a school based intervention (Miller et al., 2015), resulting in a correction factor of 5.68. The resulting student sample is 800 students at 32 schools (16 intervention, 16 control).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2019
Actual
Date of last participant enrolment
Anticipated
6/04/2020
Actual
Date of last data collection
Anticipated
26/10/2020
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 21802 0
United Kingdom
State/province [1] 21802 0
Merseyside
Country [2] 21803 0
Ireland
State/province [2] 21803 0
Dublin
Country [3] 21804 0
United States of America
State/province [3] 21804 0
Ohio

Funding & Sponsors
Funding source category [1] 303629 0
Commercial sector/Industry
Name [1] 303629 0
Nike, Inc.
Country [1] 303629 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nike, Inc.
Address
Global Social and Community Impact Team
One Bowerman Drive Beaverton, OR 97005-6453 USA
Country
United States of America
Secondary sponsor category [1] 303721 0
None
Name [1] 303721 0
Address [1] 303721 0
Country [1] 303721 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304155 0
Sheffield Hallam University
Ethics committee address [1] 304155 0
Ethics committee country [1] 304155 0
United Kingdom
Date submitted for ethics approval [1] 304155 0
18/10/2019
Approval date [1] 304155 0
Ethics approval number [1] 304155 0

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

Contacts
Principal investigator
Name 95990 0
Prof David Morley
Address 95990 0
Sheffield Hallam University
Collegiate Hall
Collegiate Crescent
Sheffield
West Yorkshire
S10 2BP
England
Country 95990 0
United Kingdom
Phone 95990 0
+447585998881
Fax 95990 0
Email 95990 0
d.morley@shu.ac.uk
Contact person for public queries
Name 95991 0
David Morley
Address 95991 0
Sheffield Hallam University
Collegiate Hall
Collegiate Crescent
Sheffield
West Yorkshire
S10 2BP
England
Country 95991 0
United Kingdom
Phone 95991 0
+447585998881
Fax 95991 0
Email 95991 0
d.morley@shu.ac.uk
Contact person for scientific queries
Name 95992 0
Andrew Miller
Address 95992 0
EN2.05, Ourimbah campus, University of Newcasle, Chitaway Rd, Ourimbah, NSW, 2258
Country 95992 0
Australia
Phone 95992 0
+61 425 308 186
Fax 95992 0
Email 95992 0
andrew.miller@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Difficult to gain ethics across four countries


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
SourceTitleYear of PublicationDOI
EmbaseRationale and study protocol for the Movement Oriented Games Based Assessment (MOGBA) cluster randomized controlled trial: A complex movement skill intervention for 8-12 year old children within 'Made to Play'.2021https://dx.doi.org/10.1371/journal.pone.0253747
N.B. These documents automatically identified may not have been verified by the study sponsor.