Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001242213
Ethics application status
Approved
Date submitted
22/05/2018
Date registered
23/07/2018
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the reliability of a scale for the measurement of variety-support for adolescents in Physical Education lessons.
Scientific title
Testing the reliability of a scale for the measurement of variety-support for adolescents in Physical Education lessons.
Secondary ID [1] 295235 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 307824 0
Obesity 307825 0
Condition category
Condition code
Diet and Nutrition 306872 306872 0 0
Obesity
Public Health 306873 306873 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to test the reliability of a scale for the measurement of variety-support for adolescents. (Variety Support definition - a social contextual concept whereby interpersonal factors facilitate a diverse range of tasks, actions, and opportunities.)

Phase 1: Variety-Support Scale Development
The Basic Needs Satisfaction in Sport Scale (BNSSS) 80 has commonly been used and is validated for measuring the psychological needs of adolescents. The BNSSS currently assesses the three constructs of autonomy, competence and relatedness in relation to sport. A variety-support scale will be developed for use with the BNSSS and will involve three steps:

Step 1 - Item development: This step involves developing potential items for assessing variety- support and determining their content validity. Based on CI Lubans and CI Lonsdale’s previous work, 30 experts in SDT will be invited to assess the content validity of the scale using established methods (experts work in fields of physical activity, education, psychology and/or Self Determination Theory). After the experts are provided with conceptual definitions of the underlying constructs (i.e. variety support vs perceived variety) they will be asked to examine the items and rate the degree to which each item matches the content using the following 5-point Likert scale: 1 = Poor match to 5 = Excellent match. Experts will also be asked to comment on the overall utility of the measure and to provide feedback for improvement. One final variety support scale will be produced at the conclusion of this step.

Step 2: Factorial validity analysis: The primary aim of this step is to establish the factorial validity of the variety-support scale in a sample of adolescents. We will recruit Grade 8 students (n=140) from NSW secondary Public schools once study approval is obtained from the relevant human ethics committees and the school principals. Participants must have informed signed consent from a parent or guardian. Sample size greater than 100 is recommended. Adolescents will answer the scale questionnaire, taking approx 5 minutes to complete. They will answer the questionnaire a single time for each version of the scale.

Step 3: Test-retest reliability analysis: The aim of this step is to determine the test–retest reliability of the final variety-support scale in a sample of adolescent boys and girls (N = 80) attending a school not involved in step 2. Adolescents will complete the variety-support scale on two occasions (1-week apart) to assess test-retest reliability.

Aikens and critical values will be used to test the internal validity of scale items.
Intervention code [1] 301189 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305973 0
The composite primary outcome is to test re-test the reliability of the variety support scale as assessed by three measures of variety;
1. rank order repeatability,
2. change in mean and
3. within-participant variation.
Timepoint [1] 305973 0
Administer first test July 2018 and re-test 1 week after first test.
Secondary outcome [1] 347153 0
NA
Timepoint [1] 347153 0
NA

Eligibility
Key inclusion criteria
Participants must be aged 13-14 years and attending a public NSW High School. Participants must have informed signed consent from a parent or guardian and be proficient readers/writers of the English language. Participants must also be able to actively participate in moderate to vigorous physical activity.
Minimum age
13 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299460 0
University
Name [1] 299460 0
The University of Newcastle, Australia
Country [1] 299460 0
Australia
Primary sponsor type
University
Name
The University of Newcastle, Australia
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 298849 0
None
Name [1] 298849 0
Address [1] 298849 0
Country [1] 298849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300366 0
The University of Newcastle Human Research Ethics Committee (EC00144)
Ethics committee address [1] 300366 0
Ethics committee country [1] 300366 0
Australia
Date submitted for ethics approval [1] 300366 0
02/03/2018
Approval date [1] 300366 0
13/03/2018
Ethics approval number [1] 300366 0

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

Contacts
Principal investigator
Name 83422 0
Ms Emily Graham
Address 83422 0
The University of Newcastle, University Dr, Callaghan NSW 2308
Country 83422 0
Australia
Phone 83422 0
+61 403236898
Fax 83422 0
Email 83422 0
[email protected]
Contact person for public queries
Name 83423 0
Emily Graham
Address 83423 0
The University of Newcastle. University Dr, Callaghan NSW 2308
Country 83423 0
Australia
Phone 83423 0
61403236898
Fax 83423 0
Email 83423 0
[email protected]
Contact person for scientific queries
Name 83424 0
Emily Graham
Address 83424 0
The University of Newcastle, University Dr, Callaghan NSW 2308
Country 83424 0
Australia
Phone 83424 0
61 403236898
Fax 83424 0
Email 83424 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
No additional documents have been identified.