Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001001684
Ethics application status
Approved
Date submitted
4/09/2014
Date registered
16/09/2014
Date last updated
16/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
‘Stand Up For Health’ an intervention to reduce adolescent sitting time during the school day
Scientific title
In adolescents aged 12-15 years, does a ‘reduced sitting’ school day, compared to a typical school day, increase students light physical activity and improve cognitive outcomes?
Secondary ID [1] 285286 0
Nil
Universal Trial Number (UTN)
U1111-1160-5260
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sitting time 292951 0
Overweight/Obese 292952 0
Cognition and Executive function 292953 0
Condition category
Condition code
Public Health 293248 293248 0 0
Health promotion/education
Cardiovascular 293249 293249 0 0
Normal development and function of the cardiovascular system
Diet and Nutrition 293287 293287 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
‘Stand up for Health’ an intervention to reduce adolescent sitting time during the school day.

6 month, 2-arm cluster RCT involving at least 120 students recruited from four secondary schools. The four schools will be pair matched based on their physical space, the number of students in Years 7 and 8, and the SES of enrolled students’ parents. All students in Years 7 and 8 will be invited to participate with parental consent. The class with the greatest number of consenting students will be selected to participate. Following baseline measures, each pair of centres will be randomised into the intervention group (n=2) or the control group (n=2).
The duration of the intervention will be 3 months. The intervention will employ strategies to reduce participants sitting time. In some instances all of the classroom students will be included in the measures, for example- breaking up sitting time by having the students break half way through class time (approximately every 30 minutes) to stand up and stretch for 2 minutes. In other instances only the study participants will be involved in the measures: e.g.participants will spend 30 minutes each day at standing desks at the rear of the classroom. They will be encouraged to use the outdoor standing tables each day at lunch for the intervening period of the study.
Personal Development, Health and Physical Education teachers will be asked to deliver a series of modules to their entire class over the intervention period (in the two intervention schools). The modules will be theoretically based using the social cognitive, behavioural choice and ecological systems theories. The modules will be delivered in 8 lessons for a 15-20 minute period. Teachers will incorporate the lessons into their timetable when it is feasible during the intervention period (3months). Students will be given relevant activities to take home and complete to further their understanding of the class content (e.g. sedentary behaviour diary). Research staff will meet with staff involved in the study to explain the intervention and modules. The teachers will be provided with lesson plans and encouraged to modify them to suit their lesson and teaching style. Lessons will focus on raising awareness about sedentary behaviour. Key messages will focus on self-monitoring and goal setting, involving students in behavioural contracts, providing social support such as team based activities and home work involving family members and feedback and reinforcement. Ideas will be provided for classroom teachers to encourage standing time, eg: rotation of activities around the classroom.
The intervention will be guided by the Social Cognitive Theory and based on the four key processes for learning and adapting new behaviours: attention, retention, production, and motivation (Bandura 1977). Regarding each of these processes, the activities have been designed to: (a) include stimulus material and specific lesson activities that engage and direct the attention of the teachers and students; (b) match students’ cognitive and behavioural skill levels and provide opportunities to enhance mastery experiences; (c) include incentives that are relevant, attractive and specified prior to the learning activities; and (d) emphasise perceived choice and control, as well as personalisation, contextualisation, challenge, curiosity and mastery through activities that enhance intrinsic motivation, greater persistence, better performance and higher satisfaction.
This will include fidelity of implementation of each component of the Program, consistency of implementation across the sites and barriers to implementation. School staff will document this at the end of each week and it will be validated by the Project Manager on a random selection of 10% of days using established procedures. Attendance rates for each student will also be collected to account for the dose of intervention received.
Intervention code [1] 290184 0
Prevention
Intervention code [2] 290185 0
Lifestyle
Intervention code [3] 290186 0
Behaviour
Comparator / control treatment
Schools randomised to the control group will continue with their usual activities. The intervention strategies will be offered to these schools at the end of the intervention period. Control schools will be offered the intervention at the end of the 3 month intervention period.
Control group
Active

Outcomes
Primary outcome [1] 293098 0
Potential efficacy/behaviour change in reducing adolescents school day sedentary behaviour, assessed with an actigraph accelerometer and an activpal device.
Timepoint [1] 293098 0
Data will be collected at baseline and 3-months after the start of the intervention.
Primary outcome [2] 293099 0
Potential efficacy/change in cognition as assessed by the Figural Intersections Task (FIT) and Executive function assessed by the Matrix reasoning test
Timepoint [2] 293099 0
Data will be collected at baseline and 3-months after the start of the intervention.
Secondary outcome [1] 310330 0
Intervention implementation: Fidelity and consistency of the program.
Timepoint [1] 310330 0
Validated by the Project Manager on a random selection of 10% of days during the 3 month intervention period
Secondary outcome [2] 310414 0
Acceptability/Feasibility of the program.
Timepoint [2] 310414 0
School staff and students at the intervention schools will be surveyed at the end of the intervening period.

Eligibility
Key inclusion criteria
Participants with a minimum age 12 years and maximum age of15 years
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students who are physically unable to participate in standing intervention activities

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)
Secondary schools will be invited to participate via email. A member of the research team will meet with interested schools to discuss the study in more detail. Schools committing to participate will be provided with information sheets and consent forms to provide to year 7 and year 8 students. Once sufficient consent forms have been received, the research team will collect baseline data from the first four schools committing to participate. Each matching pair of schools will then be randomised by an independent person to a treatment or control group using a electronic randomisation program created by Jerry Dallal which utilises randomly permuted blocks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence used was developed by the statistician Jerry Dallal Chief, Biostatistics Unit USDA Jean Mayer Human Nutrition Research Center on Aging
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomisation occurs at the school level, not the individual level. Research assistants will be blinded as to which schools are intervention or control when collecting data at follow-up.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a Cohen’s d effect size of 0.4 (i.e. a moderate effect size) and a two-tailed, 5% alpha level test, a total sample size of approximately 104 children (52 in each group) would provide 80% power to detect an effect of at least this size. This calculation is based on estimating the effect of the F statistic of the interaction term in a repeated measures design, and is inflated to account for a mild intra-class correlation coefficient (ICC; 0.01) to reflect the group randomised design. As some attrition may occur, we will increase the sample by 15% for a total of 120 children (60 in each group or 30 per school). This will require four schools to be recruited. Sample size calculations were done using G*Power and the adjustment for the ICC using the Killip formula.
Each matching pair of schools will be randomised to a treatment or control group using the biased-coin method. As participants are treated within one group it is likely that, over time, their outcomes will be correlated and ignoring this correlation may result in an inflated type I error. Post hoc the ICC for the treatment arm will be estimated, however, a priori the results of the primary outcomes will be analysed using a mixed model approach where the group is included as a nested random effect and the degrees of freedom are altered based on the number of groups. Baseline measures and relevant covariates will be included with the treatment term in the model. The analysis will be conducted using PROC MIXED in SAS.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2014
Actual
1/05/2014
Date of last participant enrolment
Anticipated
12/05/2014
Actual
18/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289907 0
Charities/Societies/Foundations
Name [1] 289907 0
National Heart Foundation of Australia
Country [1] 289907 0
Australia
Funding source category [2] 289908 0
University
Name [2] 289908 0
University of Wollongong
Country [2] 289908 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Northfields Avenue
Wollongong NSW
2522
Country
Australia
Secondary sponsor category [1] 288596 0
Charities/Societies/Foundations
Name [1] 288596 0
National Heart Foundation of Australia
Address [1] 288596 0
500 Collins Street, Melbourne VIC 3000
Country [1] 288596 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291627 0
University of Wollongong Social Science Human Research Ethics Committee
Ethics committee address [1] 291627 0
Ethics committee country [1] 291627 0
Australia
Date submitted for ethics approval [1] 291627 0
Approval date [1] 291627 0
27/03/2014
Ethics approval number [1] 291627 0
HE13/525

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

Contacts
Principal investigator
Name 51230 0
Dr Anne-Maree Parrish
Address 51230 0
School of Health and Society
Faculty of Social Sciences
University of Wollongong
Northfields ave
Wollongong NSW 2522
Country 51230 0
Australia
Phone 51230 0
+61 2 4221 5098
Fax 51230 0
+ 61 2 4221 5945
Email 51230 0
[email protected]
Contact person for public queries
Name 51231 0
Anne-Maree Parrish
Address 51231 0
School of Health and Society
Faculty of Social Sciences
University of Wollongong
Northfields ave
Wollongong NSW 2522
Country 51231 0
Australia
Phone 51231 0
+61 2 4221 5098
Fax 51231 0
+ 61 2 4221 5945
Email 51231 0
[email protected]
Contact person for scientific queries
Name 51232 0
Anne-Maree Parrish
Address 51232 0
School of Health and Society
Faculty of Social Sciences
University of Wollongong
Northfields ave
Wollongong NSW 2522
Country 51232 0
Australia
Phone 51232 0
+61 2 4221 5098
Fax 51232 0
+ 61 2 4221 5945
Email 51232 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
EmbaseEvaluation of an intervention to reduce adolescent sitting time during the school day: The 'stand Up for Health' randomised controlled trial.2018https://dx.doi.org/10.1016/j.jsams.2018.05.020
N.B. These documents automatically identified may not have been verified by the study sponsor.