Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001080910
Ethics application status
Approved
Date submitted
18/10/2011
Date registered
18/10/2011
Date last updated
14/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting Children’s Outcomes using Rewards, Exercise and Skills study
Scientific title
Evaluation of a school-based physical activity program in disadvantaged primary schools: The Supporting Children’s Outcomes using Rewards, Exercise and Skills study
Secondary ID [1] 263046 0
Nil
Universal Trial Number (UTN)
Trial acronym
SCORES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fundamental Movement Skills 270694 0
Physical Inactivity 270695 0
Condition category
Condition code
Public Health 270869 270869 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this group randomised control trial is to develop, implement and evaluate a school-based intervention to promote physical activity and improve fundamental movement skill (FMS) proficiency in children from disadvantaged primary schools. The 12-month intervention will include professional development workshops for teachers and students, school policy review and recommendations, community and parental engagement in the intervention process, student-led recess and lunchtime activities, and physical activity equipment packs. Physical activity behaviour, FMS competency, self esteem, physiological outcomes and potential mediators of behaviour change will be assessed. Assessments will be conducted at baseline 6- and 12-months.

The intervention is based on Harter’s Competence Motivation Theory and will be implemented using a socio-ecological framework. The intervention will be delivered in two stages and includes the following components:

Stage 1

i) Professional development for teachers – The research team will deliver professional development workshops for teachers. Workshops will focus on effective teaching methods for the development of FMS, strategies for assessing FMS, increasing active learning time (ALT) and promoting physical activity in PE and school sport.
a. School champion workshop: will be held at the university.
b. Whole-school workshops: will be delivered in the study schools during one of their scheduled professional development days.

ii) Student leadership – Students will be provided with an opportunity to achieve SCORES leadership accreditation. This will provide students with formal acknowledgment (i.e. certificates) and rewards (i.e. water bottles, stickers and balls) for their participation. SCORES leaders will be encouraged to help organise and deliver lunch and recess activities at school. Workshops will be delivered at the study schools during PE/school sport by the research team.

Stage 2

i) Community links – Community organisations (e.g. local football clubs) will be invited to the visit the study schools during PE/school sport. This will help to promote community sporting links.

ii) Policy and environment – 2 strategies will be used:
a. Policy review and recommendations: The research team will conduct a review of physical activity policy in the schools. The research team will work with Principals to revise policy to support the physical activity promotion.
b. Equipment and resources: Each school will be provided with physical activity equipment (e.g. bats, balls etc) and resources (e.g. activity cards) to support the implementation of the intervention based on their individual school needs (approx. $1,000).

iii) Parental engagement – 3 strategies will be used to involve parents:
a. Newsletters - Parents of study participants will be provided with newsletters to educate and encourage them to support their children’s physical activity behaviors. Newsletters will also provide updates and feedback on the project.
b. FMS Homework – Students will be encouraged to complete practical homework tasks focused on FMS development with their parents/guardians.
c. Parent evening – Parents will be invited to attend an information session on how to promote and increase physical activity and FMS in the home setting.
Intervention code [1] 269311 0
Behaviour
Intervention code [2] 269393 0
Prevention
Intervention code [3] 269394 0
Lifestyle
Comparator / control treatment
To prevent compensatory rivalry and resentful demoralisation the control schools will be provided with an equipment pack and a condensed version of the program following the 12-month assessments.

The condensed version of the intervention will include the professional development workshops for schools and students. University of Newcastle undergraduate teachers will assist in the delivery of school sport for one school term. Strategies to engage parents and a review of school physical activity policy will be conducted. The equipment pack will include a variety of sports equipment (e.g. bats, balls, cones, goals) based on individual school requirements (Approx. $1,000 AUD).
Control group
Active

Outcomes
Primary outcome [1] 279552 0
Physical activity - Students will wear accelerometers for 7 consecutive days.
Timepoint [1] 279552 0
Baseline, 6- and 12-months
Primary outcome [2] 279553 0
Cardio-respiratory fitness - Students will be assessed using a 20m shuttle test.
Timepoint [2] 279553 0
Baseline, 6- and 12-months
Primary outcome [3] 279554 0
Fundamental movement skill competency - Students will complete a standard test (TGMD II) including six locomotor and six object control skills, which will be video-taped for assessment (Ulrich 2000).
Timepoint [3] 279554 0
Baseline, 6- and 12-months
Secondary outcome [1] 287886 0
Body Mass Index (BMI) - Height and weight calculations will be measured using a portable scale and stadiometer.
Age and gender adjusted BMI z-scores will also be calculated.
Timepoint [1] 287886 0
Baseline and 12-months
Secondary outcome [2] 287888 0
Dietary behaviour - Students will complete selected items from the Australian Child and Adolescent Eating Survey (Watson, Collins et al. 2009).
Timepoint [2] 287888 0
Baseline and 12-months
Secondary outcome [3] 287889 0
Self-concept - Students will complete Harter's Self-Perception Profile (Harter 1985).
Timepoint [3] 287889 0
Baseline and 12-months
Secondary outcome [4] 287890 0
Resilience - Students will complete the Child and Youth Resilience Measure (Ungar and Liebenberg, 2011).
Timepoint [4] 287890 0
Baseline and 12-months
Secondary outcome [5] 295593 0
Enjoyment - Students will complete the Physical Activity Enjoyment Scale (PACES) (Motl, Dishman, Saunders, Dowda, Felton, & Pate, 2001).
Timepoint [5] 295593 0
Baseline and 12-months
Secondary outcome [6] 295594 0
Social support - Students will complete the Physical Activity Social Support scale (Prochaska, Rodgers, and Sallis, 2002), and the Social support in PE and school sport scale (Lubans, Morgan, & McCormack, 2011).
Timepoint [6] 295594 0
Baseline and 12-months
Secondary outcome [7] 295595 0
Physical education / sport effectiveness - PE / sport lessons will be assessed using the System for Observing Fitness Instruction Time (SOFIT) (McKenzie, 2009).
Timepoint [7] 295595 0
Baseline and 12-months

Eligibility
Key inclusion criteria
Eligible participants will be students in grades 3 and 4 attending one of the recruited study schools (government primary schools located in the Hunter Region with a Socio-Economic Indexes for Areas (SEIFA) index of less than 5).
Minimum age
7 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
SEIFA index greater than 5, non-government schools

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)
Allocation will not be concealed. Eligible low-SES schools include those with a SEIFA index of less than 5. We will recruit 6 of the schools that have been identified as eligible. Voluntary, informed and written personal consent will be obtained from all participating principals, teachers and parents. Voluntary, informed and written parental consent will be obtained for all child participants and parents will be encouraged to discuss the project details with their child before giving consent. Participants will be recruited through their school. An oral presentation will provide students and teachers with information about the study and detailed Participant Information Sheets and Consent Forms will be available for students to take home and discuss further with their parents their potential involvement in the study. In order to participate, students will need to return signed Parent Consent Forms indicating consent to participate. Parent Consent Forms ask students to return signed forms to their roll-class teacher or to the school’s front office. Once written consent is obtained, the participants will be invited to baseline assessments. Once baseline assessments have been conducted schools will be randomised to one of the two study arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The project will use a group randomised controlled trial design with schools randomly allocated to intervention or wait-list control groups for the duration of the study.

Schools will be match-paired based on size and location, then randomly allocated to the intervention or control group using a computer-based random number producing algorithm. This method ensures an equal chance of allocation to each group.

(i)The study program recipient group: student participants will receive a 12-month physical activity and fundamental movement skills program.

(ii)The wait-list control group: student participants will not receive the physical activity and fundamental movement skills program during the study period. However, program materials will be made available following the study’s completion.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait list control design. Participants assigned to the control group will receive a condensed version of the intervention at the completion of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
20/10/2011
Date of last participant enrolment
Anticipated
Actual
5/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
234
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269782 0
Other Collaborative groups
Name [1] 269782 0
Hunter Medical Research Institute
Country [1] 269782 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Hunter Medical Research Institute
Address
HMRI Clinical Research Centre
Level 3 John Hunter Hospital
Lookout Road, New Lambton Heights
NSW 2305
Country
Australia
Secondary sponsor category [1] 268881 0
None
Name [1] 268881 0
Address [1] 268881 0
Country [1] 268881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271740 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 271740 0
Ethics committee country [1] 271740 0
Australia
Date submitted for ethics approval [1] 271740 0
Approval date [1] 271740 0
Ethics approval number [1] 271740 0
H-2011-0214
Ethics committee name [2] 271830 0
Department of Education and Training
Ethics committee address [2] 271830 0
Ethics committee country [2] 271830 0
Australia
Date submitted for ethics approval [2] 271830 0
Approval date [2] 271830 0
Ethics approval number [2] 271830 0
2011200

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

Contacts
Principal investigator
Name 33102 0
A/Prof David Lubans
Address 33102 0
The University of Newcastle University Drive Callaghan NSW 2308
Country 33102 0
Australia
Phone 33102 0
+61 2 4921 2049
Fax 33102 0
Email 33102 0
[email protected]
Contact person for public queries
Name 16349 0
David Lubans
Address 16349 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 16349 0
Australia
Phone 16349 0
+61 2 4921 2049
Fax 16349 0
+61 2 4921 2084
Email 16349 0
[email protected]
Contact person for scientific queries
Name 7277 0
David Lubans
Address 7277 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 7277 0
Australia
Phone 7277 0
+61 2 4921 2049
Fax 7277 0
+61 2 4921 2084
Email 7277 0
[email protected]

No information has been provided regarding IPD availability


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
EmbasePhysical activity and skills intervention: SCORES cluster randomized controlled trial.2015https://dx.doi.org/10.1249/MSS.0000000000000452
N.B. These documents automatically identified may not have been verified by the study sponsor.