Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000978864
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
11/09/2012
Date last updated
12/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The ATLAS (Active Teen Leaders Avoiding Screen-time) obesity prevention program for adolescent boys
Scientific title
Group randomised controlled trial of the Active Teen Leaders Avoiding Screen-time (ATLAS) obesity prevention intervention for adolescent boys living in low-income communities
Secondary ID [1] 281198 0
Australian Research Council (DP120100611)
Universal Trial Number (UTN)
Trial acronym
ATLAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 287377 0
Physical inactivity 287378 0
Sedentary behaviour 287379 0
Condition category
Condition code
Public Health 287711 287711 0 0
Health promotion/education
Diet and Nutrition 287727 287727 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the Active Teen Leaders Avoiding Screen-time (ATLAS) program, which is a multi-component school-based physical activity and sedentary behaviour intervention for adolescent boys living in low-income communities who are ‘at-risk’ of obesity. The development of the program was guided by Social Cognitive Theory and Self-Determination Theory. The 8-month intervention will be delivered in two phases and includes the following components:

Phase I
Professional learning workshops for teachers: The research team will plan and deliver 2 full day professional development workshops for two teachers (1 PE teacher and 1 teacher from another key learning area). The first workshop will occur in the school term prior to the commencement of the enhanced school sport sessions and will introduce teachers to the intervention aims and objectives. It will also focus on strategies to promote physical activity, reduce sedentary behaviour and improve social and emotional well-being in adolescent boys. Teachers will be provided with opportunities to improve their resistance training and fitness skills to support the implementation of the intervention. The second workshop will occur after 4 months and will reinforce the key intervention principles and strategies. It will also provide teachers with an opportunity to reflect on their progress and share their experiences with the other teachers in the study. Both workshops will guided by SCT and SDT and will be used to reinforce the SAAFE (Supportive, Active, Autonomous, Fair and Enjoyable) teaching principles.

Phase II
The second phase of the intervention will involve a range of strategies designed to increase students’ participation in physical activity and support parents in their attempts to manage their child(ren)’s screen time behaviours. The second phase includes the following components:

(i) Interactive seminars: Boys will attend three interactive seminars delivered by members of the research team (30 minutes each). The first seminar will be delivered at baseline and will introduce key messages and strategies related to physical activity, sedentary behaviour and nutrition at the beginning of the intervention. The second seminar will occur mid-intervention and will have a “Physical Activity Leaders” focus to complement the lunchtime physical activity sessions. The final seminar will take place at the conclusion of the intervention and will review key behavioural messages.

(ii) Enhanced school sport sessions: Boys will participate in 20 weeks of enhanced school sport (1 session/week for 90 minutes). These sessions will be delivered by teachers and will include a range of vigorous physical activities designed to engage students and improve fitness. Each session will include the following components: warm-up, resistance training skill development, CrossFit style fitness challenges, minor games and cool down.

(iii) Lunch-time physical activity sessions: Boys will be encouraged to organise and deliver 10 lunchtime physical activity sessions (one session/week for 10 weeks). The aim of these sessions is to encourage boys to become “Physical Activity Leaders” in their school by taking ownership of the 30 minute weekly workouts and inviting Year 7 boys to attend. Specific leadership challenges and tasks will provide boys with an opportunity to achieve a “physical activity leader” accreditation within the school.

(iv) Parental strategies to reduce screen time: Parents will be provided with four strategies to reduce their child(ren)’s screen time: (a) suggested screen time rules, (b) screen time behavioural contract, (c) newsletters focusing on: household screen time rules, consequences of excessive screen time, strategies to manage parent/child conflict arising from screen time rules and home challenges to reduce screen time, (d) access to a screen time parental blog- to encourage parents to share their challenges and triumphs related to screen time (link: www.gettingboysactive.blogspot.com.au). The intervention strategies will be disseminated to parents using postal mail and email. The research will not have any face-to-face contact with parents.

(v) On-going professional support. Members of the research team will observe two school sport sessions at each school over the study period (once in the first 10 weeks and then another observation in weeks 11-20). Teacher will be then provided with feedback and on-going professional support.

(vi) Pedometers for self- monitoring: Boys will be provided with pedometers to use as motivational tools. They will be encouraged to set physical activity goals and self-monitor their daily activity using the pedometers.

(vii) Website, iPhone and Android application (app): The delivery of the intervention will be supported using the ATLAS website, iPhone and Android app. The ATLAS app will provide a medium for the following: (a) self-monitoring physical activity steps and CrossFit workouts, (b) peer and self-assessment of resistance training skill competency, (c) motivational and informational text messaging to reinforce health behaviours.
Intervention code [1] 285665 0
Prevention
Intervention code [2] 285673 0
Lifestyle
Intervention code [3] 285674 0
Behaviour
Comparator / control treatment
Wait list control. Students in the control group will receive standard treatment (ie. regular school sport program and health and physical education curriculum) during the intervention period and will receive a condensed version of the intervention after the 18-month follow-up assessments.
Control group
Active

Outcomes
Primary outcome [1] 287961 0
Body mass index. Height and weight will be measured using a portable scale and stadiometer.
Timepoint [1] 287961 0
Baseline, 9-months and 18-months.
Primary outcome [2] 287962 0
Waist circumference will be measured using an extendible steel tape.
Timepoint [2] 287962 0
Baseline, 9-months and 18-months.
Secondary outcome [1] 299130 0
Physical activity: will be measured over a seven day period using Actigraph accelerometers (models GT1M and GT3X).
Timepoint [1] 299130 0
Baseline, 9-months and 18-months.
Secondary outcome [2] 299131 0
Screen-based recreation: will be measured using items from the Adolescent Sedentary Activity Questionnaire (Hardy et al, 2007).
Timepoint [2] 299131 0
Baseline, 9-months and 18-months.
Secondary outcome [3] 299133 0
Key dietary behaviours: glasses of softdrink/cordial/fruit juice will be measured using items from the Australian Child and Adolescent Eating Survey food-frequency questionnaire (Watson et al, 2009).
Timepoint [3] 299133 0
Baseline, 9-months and 18-months.
Secondary outcome [4] 299134 0
Sleep-time and sleepiness: sleep-time measures will be collected using a self-report sleep log and sleepiness will be measured using the Paediatric Daytime Sleepiness Scale (Drake et al, 2003).
Timepoint [4] 299134 0
Baseline, 9-months and 18-months.
Secondary outcome [5] 299135 0
Subjective well-being: will be measured using the psychological flourishing scale (Diener et al, 2009) and its accompanying scale to assess positive and negative feelings (Diener et al, 2010).
Timepoint [5] 299135 0
Baseline, 9-months and 18-months.
Secondary outcome [6] 299136 0
Mediators of physical activity behaviour change: autonomy need satisfaction (Standage et al, 2003), competence need satisfaction (McAuley et al, 1989), relatedness need satisfaction (Richer and Vallerand, 1998), and motivation (Goudas et al, 1994) will be assessed using existing scales adapted to school sport. Physical activity behavioral strategies will be assessed using an existing valid scale (Dewar et al, in press).
Timepoint [6] 299136 0
Baseline, 6-months and 18-months
Secondary outcome [7] 299137 0
Mediators of screen time behaviour change: household screen time rules (Ramirez et al, 2011) and motivation to reduce screen-time will be assessed (developed for current study).
Timepoint [7] 299137 0
Baseline, 6-months and 18-months
Secondary outcome [8] 299138 0
Pathological video game use: will be assessed using the pathological video game use questionnaire (Gentile, 2009).
Timepoint [8] 299138 0
Baseline, 9-months and 18-months.
Secondary outcome [9] 299139 0
Resistance training skill proficiency: will be assessed by video analysis and subsequent grading using the Adolescent Resistance Training Skills Test (developed for current study), which includes the following exercises- body weight squat, push-up, lunge, suspended row, standing overhead press and front support with chest touches.
Timepoint [9] 299139 0
Baseline, 9-months and 18-months.
Secondary outcome [10] 299140 0
Muscular strength: will be assessed using a hand grip dynamometer and the seven stage abdominal strength test
Timepoint [10] 299140 0
Baseline, 9-months and 18-months.
Secondary outcome [11] 299141 0
Muscular endurance: will be assessed using the timed push-up test.
Timepoint [11] 299141 0
Baseline, 9-months and 18-months.
Secondary outcome [12] 299897 0
Perceived physical strength: will be assessed using items from the physical self-description questionnaire (Marsh, 1996).
Timepoint [12] 299897 0
Baseline, 9-months and 18-months.
Secondary outcome [13] 299898 0
Agression: will be assessed using Orpinas and Frankowski's (2001) aggression scale
Timepoint [13] 299898 0
Baseline, 9-months and 18-months.

Eligibility
Key inclusion criteria
Schools will be eligible to participate in the study if they are located in a suburb which has a Socio-Economic Indexes for Areas (SEIFA) value of less than or equal to 5.
Minimum age
12 Years
Maximum age
15 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students will be ineligible if they have a medical condition or physical injury preventing testing or participation in physical activity.

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)
Fourteen low socio-economic status (SES) secondary schools from the Hunter/Central Coast Region will be invited to participate in the study. Schools will be classified as low-SES based on having a SEIFA index of less than or equal to 5. Schools that satisfy the criteria above will be initially contacted by letter. School principals will be sent an Information Statement and Consent Letter inviting their school to participate in the study. Once schools have expressed interest in the project, the Program Manager or PhD student will contact the schools and request an opportunity to present the research proposal to the physical education teaching staff. All boys in year 7 at consenting schools will then be invited to complete an eligibility screening questionnaire. The screening questionnaire includes three items assessing children’s screen time (Hardy et al., 2010), physical activity (Morley et al., 2012) and perceived fitness levels (Ortega et al., 2011). Boys who exceed the screen time recommendations (2 or more hours/day) or fail to meet physical activity guidelines (less than 60 minutes/day of moderate to vigorous physical activity) or perceive themselves to have low levels of fitness, will be considered ‘at risk’ of obesity and will be subsequently invited to participate in the study. Once baseline data has been collected, randomisation will occur at the school level.
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.
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 following the 18-month follow-up assessments.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/10/2012
Actual
23/10/2012
Date of last participant enrolment
Anticipated
Actual
4/12/2012
Date of last data collection
Anticipated
Actual
12/06/2014
Sample size
Target
360
Accrual to date
Final
361
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285981 0
Government body
Name [1] 285981 0
Australian Research Council
Country [1] 285981 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Priority Research Centre in Physical Activity and Nutrition
Level 3 ATC
University of Newcastle
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 284799 0
Individual
Name [1] 284799 0
A/Prof David Lubans
Address [1] 284799 0
Priority Research Centre in Physical Activity and Nutrition
Level 3 ATC
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [1] 284799 0
Australia
Secondary sponsor category [2] 284800 0
Individual
Name [2] 284800 0
Prof Philip Morgan
Address [2] 284800 0
Priority Research Centre in Physical Activity and Nutrition
Level 3 ATC
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [2] 284800 0
Australia
Other collaborator category [1] 277065 0
Individual
Name [1] 277065 0
Prof Ron Plotnikoff
Address [1] 277065 0
Priority Research Centre in Physical Activity and Nutrition
Level 3 ATC
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [1] 277065 0
Australia
Other collaborator category [2] 277066 0
Individual
Name [2] 277066 0
Dr Kerry Dally
Address [2] 277066 0
School of Education
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [2] 277066 0
Australia
Other collaborator category [3] 277067 0
Individual
Name [3] 277067 0
Mr Jordan Smith
Address [3] 277067 0
Priority Research Centre in Physical Activity and Nutrition
Level 3 ATC
University of Newcastle
University Drive
Callaghan, NSW 2308
Country [3] 277067 0
Australia
Other collaborator category [4] 277068 0
Individual
Name [4] 277068 0
Prof Tony Okely
Address [4] 277068 0
Interdisciplinary Educational Research Institute
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Country [4] 277068 0
Australia
Other collaborator category [5] 277069 0
Individual
Name [5] 277069 0
Prof Jo Salmon
Address [5] 277069 0
Centre for Physical Activity and Nutrition
Deakin University
221 Burwood Highway
Burwood
Victoria 3125
Country [5] 277069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288012 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 288012 0
Ethics committee country [1] 288012 0
Australia
Date submitted for ethics approval [1] 288012 0
Approval date [1] 288012 0
04/07/2012
Ethics approval number [1] 288012 0
H-2012-0162
Ethics committee name [2] 288013 0
Department of Education and Communities
Ethics committee address [2] 288013 0
Ethics committee country [2] 288013 0
Australia
Date submitted for ethics approval [2] 288013 0
Approval date [2] 288013 0
06/09/2012
Ethics approval number [2] 288013 0
2012121

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

Contacts
Principal investigator
Name 34693 0
A/Prof David Lubans
Address 34693 0
Priority Research Centre in Physical Activity and Nutrition School of Education Callaghan Campus University Drive NSW 2308
Country 34693 0
Australia
Phone 34693 0
+61 2 49212049
Fax 34693 0
Email 34693 0
[email protected]
Contact person for public queries
Name 17940 0
A/Prof David Lubans
Address 17940 0
Priority Research Centre in Physical Activity and Nutrition
School of Education
Callaghan Campus
University Drive
NSW 2308
Country 17940 0
Australia
Phone 17940 0
+61 2 49212049
Fax 17940 0
+61 2 49217407
Email 17940 0
[email protected]
Contact person for scientific queries
Name 8868 0
A/Prof David Lubans
Address 8868 0
Priority Research Centre in Physical Activity and Nutrition
School of Education
Callaghan Campus
University Drive
NSW 2308
Country 8868 0
Australia
Phone 8868 0
+61 2 49212049
Fax 8868 0
+61 2 49217407
Email 8868 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
EmbaseAssessing the sustained impact of a school-based obesity prevention program for adolescent boys: The ATLAS cluster randomized controlled trial.2016https://dx.doi.org/10.1186/s12966-016-0420-8
N.B. These documents automatically identified may not have been verified by the study sponsor.