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Trial registered on ANZCTR


Trial ID
ACTRN12613001099718
Ethics application status
Approved
Date submitted
22/09/2013
Date registered
1/10/2013
Date last updated
1/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Increasing girls’ physical activity during an organised youth sport basketball camp: A randomised controlled trial
Scientific title
A randomised controlled trial to assess whether coaches who attended coach education sessions can increase their female athletes' moderate-to-vigorous physical activity and reduce their time spent inactive over a 5-day basketball camp; compared to a no-treatment control group.
Secondary ID [1] 283283 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 290158 0
Condition category
Condition code
Public Health 290550 290550 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The UWS School Holiday Basketball Program is a five-day basketball program assessing whether coaches who attended coach education sessions can increase their female athletes' moderate-to-vigorous physical activity (MVPA) and reduce their time spent inactive.

Half of the coaches enrolled will attend two coach education sessions following the first two days of the UWS School Holiday Basketball Program; lasting approximately two hours each session. Coach education sessions will only run on the first two days of the program. During these sessions, strategies to increase MVPA and decrease inactivity will be discussed. Coaches will also receive feedback on the physical activity levels of the athletes they coached during the program that day; as well as lesson context information based on a direct observation system (System for Observing Fitness Instruction Time; McKenzie, Sallis, & Nader, 1991).

The use of feedback allows coaches to see how active their athletes were and how they're spending their time during training (in what lesson contexts). The aims of the coach education sessions, then, are to assist coaches in identifying areas of their training sessions where it is likely they can incorporate more physical activity at a moderate-to-vigorous intensity and decrease the time spent inactive.

Intervention coaches will continue to receive feedback on the physical activity levels of the athletes as well as their lesson context information at the end of each day of the five-day program. A researcher will discretely deliver the feedback form to intervention coaches at the end of each program day.
Intervention code [1] 288005 0
Behaviour
Intervention code [2] 288006 0
Lifestyle
Intervention code [3] 288008 0
Prevention
Comparator / control treatment
Coaches randomly allocated to the control group will receive no treatment.
Control group
Active

Outcomes
Primary outcome [1] 290573 0
Physical activity - objectively measured physical activity will be measured using accelerometry (ActiGraph GT3X+ accelerometers) over 5 consecutive days (the duration of the UWS School Holiday Basketball Program).

Timepoint [1] 290573 0
Baseline (program day 1) and follow up (program day 5)
Secondary outcome [1] 304812 0
Athlete situational intrinsic and extrinsic motivation using The Situational Motivation Scale (Guay, Vallerand,& Blanchard, 2000).
Timepoint [1] 304812 0
Baseline (program day 1), follow up (program day 5)

Eligibility
Key inclusion criteria
Participants will be eligible if they are females aged 9-12 years.
Minimum age
9 Years
Maximum age
12 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be ineligible if there is prior knowledge of being unable to attend all 5 days of the basketball program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Athletes will be enrolled if a parent/guardian contacts the primary researcher and the parent/guardian's daughter meets inclusion/exclusion criteria (1. female, 2. aged 9-12, 3. intends on attending the program for its duration). If eligible, parents will be provided with informed consent/assent forms.

Participants interested in coaching the program will be enrolled if they have basketball coaching credentials and experience coaching girls basketball. They will also be informed that participation may involve attending two coach education sessions.

Once baseline data is obtained, coaches will be pair-matched by average group step counts per minute during training and one coach out of each pair will be randomly selected to attend coach education sessions (intervention). A computer generated program will be used to randomly assign a coach from each pair to either intervention or control conditions.

A computer generated program will be also be used to randomly assign half of the athletes to either intervention or control conditions. Simple randomisation will be used.

The allocation will be concealed as it will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers will be used for athletes.

Coaches will be pair-matched using the average step counts their group of athletes accumulated during their baseline training sessions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Two-arm randomised controlled trial (intervention and control group)
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
On the basis of 80% power to detect a significant change in moderate-to-vigorous physical activity (MVPA) between groups, using an effect size of d = 0.6, a sample size of 36 female athletes for each group will be needed. Assuming a 10% attrition rate, a total sample of 80 female athletes will be required.

Our effect size (d = 0.6) is consistent with the findings of a recent systematic review and meta-analysis of interventions designed to increase children and adolescents' MVPA in a similar setting (physical education), d = 0.62 (Lonsdale et al., 2013).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288021 0
University
Name [1] 288021 0
University of Western Sydney
Address [1] 288021 0
University of Western Sydney, Locked Bag 1797 Penrith South 2751, NSW
Country [1] 288021 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
University of Western Sydney, Locked Bag 1797 Penrith South 2751, NSW
Country
Australia
Secondary sponsor category [1] 286738 0
None
Name [1] 286738 0
Address [1] 286738 0
Country [1] 286738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289944 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 289944 0
University of Western Sydney, Locked Bag 1797 Penrith South 2751, NSW
Ethics committee country [1] 289944 0
Australia
Date submitted for ethics approval [1] 289944 0
Approval date [1] 289944 0
14/06/2013
Ethics approval number [1] 289944 0
H10215

Summary
Brief summary
The primary aims of this two-armed randomised controlled trial are to assess whether coaches who attended coach education sessions can increase their female athletes' moderate-to-vigorous physical activity and reduce their time spent inactive during training sessions over a 5-day basketball program; compared to a no-treatment control group. Therefore, we hypothesise that:

1) Girls who are being coached by coaches who have attended coach education sessions will spend a greater percentage of time moderately-to-vigorously physically active compared to girls who are coached by coaches who did not attend coach education sessions.

2) Girls who are being coached by coaches who have attended coach education sessions will spend a lower percentage of time inactive compared to girls who are coached by coaches who did not attend coach education sessions.

The target population for this study will be girls aged 9-12 years willing to partake in a 5-day basketball camp; and coaches, with basketball coaching certification and experience coaching girls, willing to coach a 5-day basketball camp.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43190 0
Mr Justin Guagliano
Address 43190 0
University of Western Sydney, Locked Bag 1797 Penrith South 2751, NSW
Country 43190 0
Australia
Phone 43190 0
+61 2 4620 3269
Fax 43190 0
Email 43190 0
j.guagliano@uws.edu.au
Contact person for public queries
Name 43191 0
Mr Justin Guagliano
Address 43191 0
University of Western Sydney, Locked Bag 1797 Penrith South 2751, NSW
Country 43191 0
Australia
Phone 43191 0
+61 2 4620 3269
Fax 43191 0
Email 43191 0
j.guagliano@uws.edu.au
Contact person for scientific queries
Name 43192 0
Mr Justin Guagliano
Address 43192 0
University of Western Sydney, Locked Bag 1797 Penrith South 2751, NSW
Country 43192 0
Australia
Phone 43192 0
+61 2 4620 3269
Fax 43192 0
Email 43192 0
j.guagliano@uws.edu.au