Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000341426
Ethics application status
Approved
Date submitted
27/11/2015
Date registered
16/03/2016
Date last updated
20/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Childcare based intervention to reduce sitting time in preschoolers
Scientific title
The feasibility, acceptability, and potential efficacy of a reduced sitting day on physical activity and executive function among pre-school-aged children
Secondary ID [1] 287768 0
Nil known
Universal Trial Number (UTN)
U1111-1176-0818
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity 296651 0
Sitting time 296652 0
Cognition 296876 0
Condition category
Condition code
Public Health 296877 296877 0 0
Health promotion/education
Mental Health 297129 297129 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four childcare services (approx. 120 children) will be randomised to either modifying their service to reduce sitting (“Stand more-Sit less” environment) or keeping it as it currently is (typical environment).

The results of the calorimeter study (ACTRN12614001028695) will inform the intervention as to activities constituting a “typical” school day with around 50% of time spent sitting and a “stand and move more, sit less” school day with around 25% of time spent sitting; i.e., a 25% reduction in total sitting time which should also result in a 25% increase in light-intensity activity. The intervention strategy will include measures to break up sitting time and reduce sitting time such as the use of standing desks and active energy breaks.
Research staff will meet with staff involved in the study at baseline during a staff meeting (approx 1 hr) to explain the intervention. The childcare educators will be provided with a preschool routine and encouraged to modify them to suit there routine and teaching style. They further provide them with ideas to encourage standing time, eg: taking away chairs during drawing. We will use an observation checklist to examine the process of the intervention once every 3 weeks by the research student.
Centres 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 (3 months).

This intervention will be guided by the Social Cognitive Theory which is based on the four key processes for learning and adapting new behaviours: attention, retention, production, and motivation.
Intervention code [1] 293162 0
Behaviour
Comparator / control treatment
Childcare services randomised to the control group will continue with their usual activities. The intervention strategies will be offered to these services at the end of the intervention period (after 3 months).
Control group
Active

Outcomes
Primary outcome [1] 296716 0
Sitting time (activPal), the activPAL will be worn at least one day during their time at Childcare.
Timepoint [1] 296716 0
Baseline and 3-month follow-up
Primary outcome [2] 296747 0
Executive function will be measured using three iPad games: Fish and shark (Go No Go test), Mr Ant (testing working memory) and Card Sorting game (the ability to switch tasks)
Timepoint [2] 296747 0
Baseline and 3-month follow-up
Secondary outcome [1] 319173 0
Standing time (activPal), the activPAL will be worn at least one day during their time at Childcare.
Timepoint [1] 319173 0
Baseline and 3-month follow-up
Secondary outcome [2] 339967 0
Intervention implementation (fidelity of implementation, consistency of implementation and barriers to implementation). Measured using observations and interviews with the educators.
Timepoint [2] 339967 0
Observations during the intervention and interviews at follow-up (12 weeks)
Secondary outcome [3] 339968 0
Sitting bouts and the number of interruptions (breaks - defined as the number of transitions recorded from ‘‘sit/lie’’ posture to ‘‘stand’’) (measured using the activPAL)
Timepoint [3] 339968 0
Baseline and Follow-up (12 weeks)
Secondary outcome [4] 339969 0
Stepping time (activPal), the activPAL will be worn at least one day during their time at Childcare.
Timepoint [4] 339969 0
Baseline and Follow-up (after 12 weeks)

Eligibility
Key inclusion criteria
Preschoolers attending childcare
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children who were 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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 childcare center). This will require four childcare services 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 centres 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
Completed
Date of first participant enrolment
Anticipated
15/04/2016
Actual
15/04/2016
Date of last participant enrolment
Anticipated
22/04/2016
Actual
22/05/2016
Date of last data collection
Anticipated
Actual
10/11/2016
Sample size
Target
120
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292457 0
University
Name [1] 292457 0
University of Wollongong
Country [1] 292457 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue
Keiraville
2522 NSW
Country
Australia
Secondary sponsor category [1] 291155 0
None
Name [1] 291155 0
N/A
Address [1] 291155 0
N/A
Country [1] 291155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293920 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 293920 0
Ethics committee country [1] 293920 0
Australia
Date submitted for ethics approval [1] 293920 0
14/03/2016
Approval date [1] 293920 0
16/03/2016
Ethics approval number [1] 293920 0

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

Contacts
Principal investigator
Name 50878 0
Prof Tony Okely
Address 50878 0
Early Start Research Institute Building 21, room 110. Northfields Avenue, University of Wollongong. NSW 2533
Country 50878 0
Australia
Phone 50878 0
+61 02 42214641
Fax 50878 0
Email 50878 0
[email protected]
Contact person for public queries
Name 50879 0
Yvonne Ellis
Address 50879 0
Early Start Research Institute
Building 21, room 110.
Northfields Avenue, University of Wollongong.
NSW 2533
Country 50879 0
Australia
Phone 50879 0
+61 02 42215486
Fax 50879 0
Email 50879 0
[email protected]
Contact person for scientific queries
Name 50880 0
Yvonne Ellis
Address 50880 0
Early Start Research Institute
Building 21, room 110.
Northfields Avenue, University of Wollongong.
NSW 2533
Country 50880 0
Australia
Phone 50880 0
+61 02 42215486
Fax 50880 0
Email 50880 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

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