Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000744954
Ethics application status
Approved
Date submitted
4/05/2020
Date registered
16/07/2020
Date last updated
16/07/2020
Date data sharing statement initially provided
16/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of a Multi–Component Intervention on Motor Skill Competency, Physical Fitness, Strength, Physical Activity Levels and Self Esteem in Preadolescent Females
Scientific title
The Effects of a Multi–Modal Intervention on Motor Skill Competency, Physical Fitness, Strength, Physical Activity Levels and Psycho-Social Health in Preadolescent Females
Secondary ID [1] 300741 0
Nil known
Universal Trial Number (UTN)
U1111-1249-4104
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low motor skill competency 316563 0
Poor aerobic fitness 316564 0
low strength 316565 0
low levels of physical activity and high levels of sedentary time 316566 0
low self-esteem 316567 0
Unhealthy weight status 316568 0
Condition category
Condition code
Cardiovascular 314804 314804 0 0
Other cardiovascular diseases
Mental Health 314805 314805 0 0
Other mental health disorders
Metabolic and Endocrine 314807 314807 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A movement-based intervention program called Move-Girls. The intervention consists of girls participating in an after-school based physical activity program being run out of Edith Cowan University Children's Physical Activity Hub. The program has multi components including fundamental movement skills (FMS), high intensity interval training (HIIT) and strength activities. Program duration is twice per week, 60 min per session, for ten weeks (20 sessions) to follow school term.
The program will be designed and delivered by Chief Investigator, Kylie Cormack, who has qualifications and expertise in education and exercise & sports science. Graduating students from ECU's, Exercise and Sports Science course will be assisting in the delivery.
There will be one multi-modal intervention group (A) plus a control group (B). Group A will follow the intervention described below and Group B will continue with their ‘normal’ weekly activity
The organisation for the intervention program will include a warm up (10 min), HIIT/ FMS (30 min), strength activities (15 min) and cool down (5 min). The intervention organisation aims to be time efficient.
Intervention components (HIIT/ FMS / Strength)
The HIIT cycling protocol will be performed on stationary bicycle ergometers with each subject completing three sets; each set will consist of four bouts (i.e. 30 seconds of cycling followed by 30 seconds rest). A four min ‘rest period’ will be allocated between each set. The intensity will be > 90% maximum heart rate (MHR) or using Children’s ONMI Scale of perceived exertion ‘very hard to very very hard’. During the four min ‘rest period’, subjects will participate in an active FMS activity.
FMS protocol. The subjects will view a short video of an expert performance of a FMS (i.e. overarm throw) which will be followed by an opportunity to practice and then receive feedback from an instructor. Fun based FMS activities using a variety of equipment will be set up in the space to practice the FMS (e.g. throwing for distance and accuracy using different size and weighted balls, kicking into targets, striking different size balls off batting tees, dribbling balls around obstacles). The program will progress weekly covering all main FMS and towards the latter half of the program sport specific skills (e.g. netball passing, football (AFL) handball) will be introduced.
The strength component will be delivered by a circuit which will include different combinations of body weight type activities (e.g. plank, squats, push ups, sit ups, mountain climbers, tricep dips, fun-based animal walks [crab/bear] - workload 30 sec bouts), resistance exercises using light dumbbells (e.g. bicep curls, overhead press - 12 reps) and other strength exercises (e.g. battle rope exercises, boxing for fitness activities, medicine ball slams - working in bouts of 30 sec). Individual workloads (e.g. time, load, reps) will be varied as the child's strength improves.
Fidelity – The facilitator will self report. For example, they will use a checklist for each session and tick off what was covered in the session and whether the girls engaged or spent the intended amount of time on the activity as outlined planned.
Intervention code [1] 317063 0
Lifestyle
Intervention code [2] 317064 0
Behaviour
Comparator / control treatment
There will be two groups: Intervention and Control
The intervention group will participate in the Move-Girls program
The control group will carry on with their 'normal' daily activity
Control group
Active

Outcomes
Primary outcome [1] 323167 0
Change in physical activity levels. Assessed by composite of 1) Physical Activity Questionnaire for Children (PAC-Q) and 2) Hip worn tri-axial accelerometer (physical activity monitoring devise worn for 7 days).
Timepoint [1] 323167 0
Baseline, one week post intervention and 6 months (primary timepoint) post intervention
Primary outcome [2] 323168 0
Change in Motor Skill Competency measured by a composite of 1) performance in selected tests from the Movement Assessment Battery for Children and 2) number of 'proficient' skill criteria identified for four fundamental movement skills.
Timepoint [2] 323168 0
Baseline and one week post intervention (primary timepoint)
Primary outcome [3] 323169 0
Change to Psycho-social health: ‘Paediatric Quality of Life Inventory’ measures psycho-social health. Responses to the questionnaire will provide information about students well-being and health (physical, emotional, school and social functioning).
Timepoint [3] 323169 0
Baseline, one week post intervention and 6 months (primary timepoint) post intervention
Secondary outcome [1] 381021 0
Change to cardiorespiratory fitness levels as measured by composite of three minute step test and 20m aerobic multi-stage shuttle test.
Timepoint [1] 381021 0
Baseline and one week post intervention
Secondary outcome [2] 381022 0
Change in strength as measured by composite of Isometric mid-thigh pull and hand grip strength
Timepoint [2] 381022 0
Baseline and one week post intervention
Secondary outcome [3] 381023 0
Change in body weight status as measured by body mass index in combination with waist to hip circumferences ratio
Timepoint [3] 381023 0
Baseline and one week post intervention
Secondary outcome [4] 381024 0
Change to perceived motor skill competency as measured by responses to specific questions from the Self Description -1 Questionnaire.
Timepoint [4] 381024 0
Baseline, one week post intervention and 6 months post intervention
Secondary outcome [5] 383607 0
Change in sports participation: measured by Physical Activity Questionnaire for Children (PAQ-C)
Timepoint [5] 383607 0
Baseline, one week post intervention and 6 months post intervention

Eligibility
Key inclusion criteria
Children who are 'not yet' proficient in their motor skill level
Minimum age
8 Years
Maximum age
11 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with high motor skill level or have proficient motor skills

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
130 participants will be stratified by pretest motor skills competency and age, and randomly allocated into the equal-sized intervention and control groups. Performing a priori sample size calculations using power=0.8, significance level=0.05, an effect size f=0.09 (determined from results in Barnett et al., 2009), two independent groups and four repeated measures, 104 preadolescent females (~8-11 years of age) will be recruited for Study 1. However, 130 preadolescent females will be recruited since Study 2 is a longitudinal study design stretching over 12 months and there will be a need to control for a conservative 25% attrition rate in the study.
Study 1 Intervention Study :
To analyse the relationship between overall motor skill competency with CRF, strength, PA, BMI and W:H, Spearman’s correlation coefficient will be performed between the independent variable of motor skill competency and dependant variables: CRF (predicted VO2max ml.kg-1.min-1), strength (N/kg) and BMI kg/m2 converted to percentile for age, sex and W:H. A Benjamini-Hochberg will be applied to this data. To determine which of CRF, strength, PA, BMI and W:H independently assciate with overall motor skill competency, these variables (dependent and independent) will be converted to Z scores and a multiple linear regression will be implemented. To evaluate the effectiveness of the multi-modal intervention (consisting of FMS, HIIT and strength) in preadolescent females, a mixed ANOVA model will be implemented for each of the variables, which analyses the change in pre- and post-test results between the two independent groups. A Benjamini-Hochberg method will be used to adjust the false-discovery rate. An alpha level of <0.05 will be applied.
Study 2: Comparison of intervention and control groups one year post intervention
A Linear Mixed Effects model (or generalised linear mixed effects model if non-normal), with a random intercept (to control for different starting points for each subject) will be used to assess changes over time in study participants. For between-group differences, the Longitudinal Generalised Estimating Equation will be used. Scores on the self-report measures (physical activity levels, quality of life) will be calculated according to the published algorithms as described in Study 1. In addition, to determine whether compliance with the intervention is significant with changes to physical activity, sport participation and psycho-social health possible determinants of effectiveness will be established using Spearman's rank correlation coefficient. Test results are considered significant for p-values <0.05. To determine the difference between self-reported and actual physical activity levels a Bland-Altman method will be used which provides a means for assessing the level of agreement between self-report and direct measures by deriving the mean difference between the two measures and the limits of agreement (Prince et al., 2008). To determine the relationship between self-reported and actual levels of physical activity a Pearson’s correlation coefficient will be used. To determine which variable(s) (motor skill competency, CRF, weight status, strength, and psycho-social health) has a higher association with PA levels, a Spearman’s rank correlation coefficient will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2020
Actual
Date of last participant enrolment
Anticipated
18/01/2021
Actual
Date of last data collection
Anticipated
29/11/2021
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 305192 0
University
Name [1] 305192 0
Edith Cowan University
Country [1] 305192 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive Joondalup WA 6027 Australia
Country
Australia
Secondary sponsor category [1] 305553 0
None
Name [1] 305553 0
Address [1] 305553 0
Country [1] 305553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305547 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 305547 0
Ethics committee country [1] 305547 0
Australia
Date submitted for ethics approval [1] 305547 0
24/01/2020
Approval date [1] 305547 0
08/04/2020
Ethics approval number [1] 305547 0

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

Contacts
Principal investigator
Name 100746 0
Mrs Kylie Cormack
Address 100746 0
Edith Cowan University
270 Joondalup Drive, Joondalup 6027 WA Australia
Country 100746 0
Australia
Phone 100746 0
+61 0427927325
Fax 100746 0
Email 100746 0
[email protected]
Contact person for public queries
Name 100747 0
Kylie Cormack
Address 100747 0
Edith Cowan University
270 Joondalup Drive, Joondalup 6027 WA Australia
Country 100747 0
Australia
Phone 100747 0
+61 0427927325
Fax 100747 0
Email 100747 0
[email protected]
Contact person for scientific queries
Name 100748 0
Kylie Cormack
Address 100748 0
Edith Cowan University
270 Joondalup Drive, Joondalup 6027 WA Australia
Country 100748 0
Australia
Phone 100748 0
+61 0427927325
Fax 100748 0
Email 100748 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
Has not been included in the ethics application


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.