Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000352808
Ethics application status
Approved
Date submitted
1/02/2021
Date registered
26/03/2021
Date last updated
26/03/2021
Date data sharing statement initially provided
26/03/2021
Date results provided
26/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Resistance Training for Teens (RT for Teens) school-based health-related fitness program for adolescents
Scientific title
Evaluating the state-wide dissemination of a school-based physical activity intervention incorporating smartphone technology to improve adolescents' health-related fitness
Secondary ID [1] 303291 0
None
Universal Trial Number (UTN)
Trial acronym
RT for Teens
Linked study record
This study is the next phase of ACTRN12615000360516. The aforementioned study was a cluster RCT which evaluated the RT for Teens program, prior to state-wide dissemination (the current study).

Health condition
Health condition(s) or problem(s) studied:
Poor health-related fitness 320501 0
Physical inactivity
 320502 0
Psychological wellbeing 320504 0
Sedentary behaviour 320505 0
Obesity 320506 0
Condition category
Condition code
Public Health 318368 318368 0 0
Health promotion/education
Diet and Nutrition 318369 318369 0 0
Obesity
Mental Health 318370 318370 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RT for Teens is a school-based health-related fitness program for secondary students. It was designed to be delivered over one school term (10-weeks). The intervention was delivered through either: i) compulsory PE; ii) co-curricular school sport; or iii) an elective course known as Physical Activity and Sports Studies (PASS).

The intervention was guided by Social Cognitive Theory and Self-Determination Theory (SDT), and included:
1. An interactive student seminar - Teacher delivered (20-30 minutes during week 1). Provided key information regarding the program components. It also provided an overview of the purpose-built smartphone app and its functions. The student seminar was designed to engage the students, integrating videos and websites, student quizzes and opportunities for student input and discussion.
2. An RT focused physical activity program. Teachers encouraged to deliver 1 x session per week for 10 weeks, following the suggested session structure: bodyweight and elastic tubing RT, high intensity resistance training workouts, strength-,flexibility- and aerobic-based activities, and modified game involving fitness infusion. However, given the varied nature of schools, session timing (ranging from 15-90 minutes) and specific inclusions was flexible for teachers. These sessions were focused on improving students' resistance training skills, through body weight and elastic tubing RT instruction, demonstration and practice.
3. Access to a purpose-built smartphone app, designed to promote RT skills in students. App functions include: fitness testing, RT technique assessment, high intensity RT workouts, and exercise library. App usage was encouraged, but not mandated, with usage data collected to assess usage of various components.

To enhance program success, the following implementation components were also utilised: school champions, professional learning workshop for teachers (delivered by the research team, at various school locations over the course of the study, over one-day [5 hours], to a maximum of 30 teachers), teacher handbook (designed specifically for the study), session resources, and physical activity session observation and feedback. Teachers were trained to deliver the program during a full-day professional learning workshop. The workshop will introduce teachers to the intervention aims and objectives. It also focused on strategies to promote health-related fitness and physical activity, reduce sedentary behaviour, and improve social and emotional well-being in adolescents. Teachers were provided with opportunities to improve their confidence and competence to model and teach resistance training and fitness skills. The workshop provided teachers with an introduction to the principles of SDT, embedded through the SAAFE (Supportive, Active, Autonomous, Fair and Enjoyable) teaching principles, which were used to guide their teaching during their facilitation of the RT for Teens program.

Each school received program resources including circuit and workout cards (which were made specifically for the program), access to the smartphone app, and a teacher handbook to assist with program planning and delivery.
Intervention code [1] 319596 0
Lifestyle
Intervention code [2] 319597 0
Prevention
Intervention code [3] 319598 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326344 0
Reach into the student population

Number and proportion of the students that participate in the programs compared to total number of students at participating schools; estimate calculated via teacher workshop enrolment data, class size data, and school enrolment data
Timepoint [1] 326344 0
Calculation done at the end of the dissemination evaluation period (October 2020)
Primary outcome [2] 326686 0
Representativeness of students/schools who participate in the program
Age, sex, indigenous status, SES, ethnicity/cultural background, locality, language spoken at home of students who participate in the programs compared to others in the school. School demographics also assessed, and compared to current state-level school demographic data.
Timepoint [2] 326686 0
Representativeness assessed at the end of the dissemination evaluation period (October 2020).
Primary outcome [3] 326687 0
Effectiveness in improving student outcomes

Muscular fitness - assessed using 90-degree push-up test (Cooper Institute for Aerobics Research 2004) and the standing long jump test (Ruiz et al., 2011)
Timepoint [3] 326687 0
Baseline and 10-weeks (post-program)
Secondary outcome [1] 391126 0
Effectiveness in improving student outcomes (additional primary outcome)

Self-reported PA - assessed using a single-item self report measure developed for use with adolescents (Scott et al., 2015)
Timepoint [1] 391126 0
Baseline and 10-weeks (post-program)
Secondary outcome [2] 392353 0
Effectiveness in improving student outcomes (additional primary outcome)

Perceived fitness - assessed using the International Fitness Scale (IFIS) (Sanchez-Lopez et al., 2014)
Timepoint [2] 392353 0
Baseline and 10-weeks (post-program)
Secondary outcome [3] 392354 0
Effectiveness in improving student outcomes (additional primary outcome)

Resistance training self-efficacy - assessed using a four-item scale developed for use with adolescents (Lubans et al., 2011)
Timepoint [3] 392354 0
Baseline and 10-weeks (post-program)
Secondary outcome [4] 392355 0
Effectiveness in improving student outcomes (additional primary outcome)

Autonomous motivation for PA - assessed using the autonomous motivation sub-scale of the Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) (Markland Tobin, 2004)
Timepoint [4] 392355 0
Baseline and 10-weeks (post-program)
Secondary outcome [5] 392356 0
Effectiveness in improving student outcomes (additional primary outcome)

Autonomous motivation for RT - assessed using an adapted version of the Behavioural Regulations in Exercise Questionnaire-2 (BREQ-2) (Markland and Tobin, 2004)
Timepoint [5] 392356 0
Baseline and 10-weeks (post-program)
Secondary outcome [6] 392357 0
Adoption of the RT for Teens program by teachers/schools (additional primary outcome)

Number of schools represented by teachers at the professional learning workshops. Proportion of indigenous students, school type (e.g., SSPs, Co-Ed vs single-sex), school size, proportion of ESL students, SEIFA value, geographic location, school facilities compared to other schools in NSW. Determined via teacher workshop enrolment data and school demographic data
Timepoint [6] 392357 0
Teacher enrolments assessed at the end of the dissemination evaluation period (October 2020)
Secondary outcome [7] 392358 0
Adoption of the RT for Teens program by teachers/schools (additional primary outcome)

Number, proportion and representativeness of teachers that participate in the professional learning workshop. Determined via teacher workshop enrolment data and pre-workshop survey data
Timepoint [7] 392358 0
Teacher enrolments and surveys assessed at the end of the dissemination evaluation period (October 2020)
Secondary outcome [8] 392359 0
Implementation of the RT for Teens program by teachers/schools (additional primary outcome)

Quality of teacher session implementation determined using observations conducted by the research team. Teachers offered for members of the research team to observe a session at their school over the 10-week period. Teachers were provided with constructive feedback and professional support. This component also assessed intervention fidelity (i.e., session components utilised and adherence to the SAAFE teaching principles outlined during the pre-program professional learning workshop).
Timepoint [8] 392359 0
Mid-intervention at selected schools (approximately weeks 4-7 of program delivery)
Secondary outcome [9] 392360 0
Implementation of the RT for Teens program by teachers/schools (additional primary outcome)

App usage data collected and analysed, to determine number of users and components of the app utilised throughout the dissemination period.
Timepoint [9] 392360 0
App data assessed at the end of the dissemination evaluation period (October 2020)
Secondary outcome [10] 392361 0
Maintenance of the program and/or its effects (additional primary outcome)

Enrollment of teachers from the same school in the RT for Teens workshop, after the initial teacher has received training.
Timepoint [10] 392361 0
Teacher enrolments assessed at the end of the dissemination evaluation period (October 2020)

Eligibility
Key inclusion criteria
All government secondary schools in NSW were eligible to participate, including their staff (for training) and students (for participation).
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be ineligible if they have a medical condition or physical injury preventing participation in physical activity.

Study design
Purpose of the study
Prevention
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/08/2015
Date of last participant enrolment
Anticipated
Actual
21/11/2019
Date of last data collection
Anticipated
Actual
30/10/2020
Sample size
Target
240
Accrual to date
Final
468
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307708 0
Government body
Name [1] 307708 0
Australian Research Council
Country [1] 307708 0
Australia
Funding source category [2] 307712 0
Government body
Name [2] 307712 0
NSW School Sport Unit
Country [2] 307712 0
Australia
Primary sponsor type
Individual
Name
Prof David Lubans
Address
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 308405 0
Individual
Name [1] 308405 0
Prof Philip Morgan
Address [1] 308405 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [1] 308405 0
Australia
Secondary sponsor category [2] 308409 0
Individual
Name [2] 308409 0
Prof Ronald Plotnikoff
Address [2] 308409 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [2] 308409 0
Australia
Secondary sponsor category [3] 308410 0
Individual
Name [3] 308410 0
Dr Jordan Smith
Address [3] 308410 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [3] 308410 0
Australia
Secondary sponsor category [4] 308411 0
Individual
Name [4] 308411 0
A/Prof Narelle Eather
Address [4] 308411 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [4] 308411 0
Australia
Secondary sponsor category [5] 308412 0
Individual
Name [5] 308412 0
Ms Sarah Kennedy
Address [5] 308412 0
Priority Research Centre for Physical Activity and Nutrition
Level 3 ATC building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [5] 308412 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307736 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 307736 0
Ethics committee country [1] 307736 0
Australia
Date submitted for ethics approval [1] 307736 0
15/09/2014
Approval date [1] 307736 0
23/10/2014
Ethics approval number [1] 307736 0
H-2014-0312
Ethics committee name [2] 307742 0
New South Wales Department of Education and Communities ethics committee
Ethics committee address [2] 307742 0
Ethics committee country [2] 307742 0
Australia
Date submitted for ethics approval [2] 307742 0
17/09/2014
Approval date [2] 307742 0
18/11/2014
Ethics approval number [2] 307742 0
2012121

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

Contacts
Principal investigator
Name 108330 0
Prof David Lubans
Address 108330 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 108330 0
Australia
Phone 108330 0
+61 02 49212049
Fax 108330 0
Email 108330 0
[email protected]
Contact person for public queries
Name 108331 0
David Lubans
Address 108331 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 108331 0
Australia
Phone 108331 0
+61 02 49212049
Fax 108331 0
Email 108331 0
[email protected]
Contact person for scientific queries
Name 108332 0
David Lubans
Address 108332 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 108332 0
Australia
Phone 108332 0
+61 02 49212049
Fax 108332 0
Email 108332 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


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.