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Trial registered on ANZCTR


Registration number
ACTRN12616000471482
Ethics application status
Approved
Date submitted
24/03/2016
Date registered
11/04/2016
Date last updated
24/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of reduced sitting on toddlers’ cognitive development: a cluster randomised controlled trial.
Scientific title
Effects of reduced sitting on toddlers’ cognitive development: a cluster randomised controlled trial.
Secondary ID [1] 288844 0
none
Universal Trial Number (UTN)
U1111-1175-8691
Trial acronym
GET UP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Development in Toddlers 298129 0
Condition category
Condition code
Mental Health 298296 298296 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 298297 298297 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our primary aim is to assess the effects of a 12 months intervention reducing sitting time during childcare on Executive Functions in a cluster randomised controlled trial in Australian toddlers from low socio-economic families. We hypothesise that at follow-up, toddlers in centres allocated to the intervention group will have improved their cognitive development by 0.5 SD more than toddlers in childcare centres randomly allocated to the control group. The secondary aims are to examine the effects of the intervention (i) on time spent in total sitting and bouts of sitting (ii) on time spent in total physical activity and moderate-to-vigorous physical activity (iii) on bone mineral density and (iv) and on cardiovascular health.

We will implement a 2-arm parallel group cluster randomised controlled trial comparing a reduced sitting time intervention with usual childcare practice (control group). The sampling frame will comprise 16 childcare services, selected using recognised indexes for socioeconomic disadvantage and early development. We will ensure that the centres we approach are ones that do not have any current research projects with this age group to ensure they are not overburdened. In Early Start, we have a comprehensive database that contains the names of all the centres where research is currently being conducted, the nature of this research, timeframes, and ages of children who are involved. This database will be consulted prior to approaching any centres.

The intervention has been designed in response to formative research conducted by ESRI within similar childcare services in disadvantaged locations. In 2013, 12 focus groups were held with educators from 11 services. Educators were provided with data on how much time children in their service spent sitting and asked to identify by how much they would like to reduce this proportion of time. The most common reduction was 50% of the time currently spent sitting. Based on the proportions presented above, this would result in reducing a “typical” day (50% or half of the time in childcare spent sitting) to 25% of the time spent sitting. Educators were then asked to complete a daily routine for their service, which described the modifications that would take place to allow the halving of time spent sitting. Researchers then provided further ideas. The ideas provided by educators largely focused on changes to practices and modifications to the physical environment. Included in these ideas were ways to ensure no bouts of sitting exceeded 15 minutes. These example schedules will be used by each of the intervention childcare services to design their own daily schedule to reduce total sitting time by 50% and to reduce bouts of sitting to <15 minutes. Exemples of practice and environmental changes include: removing the chairs way from the tables for painting activities, action time stories (children can role-play the story), settling the play/learning equipment/areas near the wall of the room to create an open space in the centre of the room, remove chairs and tables from the outdoor space.
Educators from the intervention centres will attend a 6 hours professional development workshop. The workshop will begin by introducing the rationale and aims of the study (1 hour). Educators will then be asked to think about ways to (i) modify routine activities to reduce the total amount of sitting time and reduce bouts of sitting to less than 15 min and (ii) to change indoor and outdoor environment to reduce the total amount of sitting time and the length of the sitting bouts. (1 hour). After this activity, the educators will be able to rehearsal some of the proposed activities in our laboratory (2 hour and 30 min).Finally, educators will be given further ideas on how to reduce toddlers’ total sitting time and reduce bouts of sitting to less than 15 min. Perceived barriers for the implementation of the program and possible solutions to overcome these barriers will be discussed (1 hour and 30 minutes).
All educators will receive training on the same day to ensure standardization of content delivery.
After the professional development workshop we will provide educators with supporting written materials with the rationale, aims and strategies/activities to reduce toddler’s sitting time. We will provide them with posters to be displayed in their classroom as a reminder of the need to reduce sitting time. A video demonstrating the proposed activities and desired routine changes will also be provided.
During the intervention period the educators will receive monthly on-site visits from the research team, to revise key activities and behavioural strategies to reduce toddlers’ total sitting time and to follow up on the activities that are being undertaken.

Three months and six months after the start of the intervention educators will attend an interactive online webinar to follow-up on the intervention, to share ideas and perceived barriers of the intervention implementation and to address possible solutions to overcome those barriers.
During the intervention period educators will also receive regular emails and telephone calls.
During the monthly visits the research staff will collect objective information on the total sitting time and sitting bouts (by accelerometry) in a random small sample of toddlers (10%) to monitor the implementation of the intervention. This performance will be delivered to the educators, providing feedback on the intervention implementation.
Intervention code [1] 294300 0
Behaviour
Intervention code [2] 294301 0
Lifestyle
Comparator / control treatment
The Control Group will continue with their usual program and will receive the intervention training and materials at the end of the intervention, after the follow-up assessments (15 months after the intervention group)
Control group
Active

Outcomes
Primary outcome [1] 297778 0
Cognitive development and executive function will be assessed using the Cognitive sub-test from the Bayley Scales of Infant and Toddler Development. For those children who have turned 3 at follow-up, an additional four executive function tasks, which have been designed and psychometrically tested with preschool-aged children, will be used to ensure assessments are comprehensive. These tasks assess three key executive function components; 1) go/no-go task (inhibition); 2) backward span task, and 3) complex span task (both assess working memory); and 4) dimensional change card sort (cognitive flexibility). Current pilot work being undertaken in preschools by our research institute indicates that these tasks can be completed in less that 60 min per child. Cognitive assessments and executive function tests will be conducted individually in a private area and will be scheduled on separate days, where possible, so that children have breaks and do not experience fatigue.
Timepoint [1] 297778 0
At baseline and at the end of the intervention (15 months post enrolment)
Secondary outcome [1] 322189 0
Composite secondary outcomes include total time spent sitting and bouts of sitting during childcare hours will be assessed over a one week period using an activPAL accelerometer. The activPAL (PAL technologies, Glasgow) is small (53 x 35 x 7mm) and lightweight (15g) and is placed on the front of the upper thigh (using a small hypo-allergenic adhesive gel patch, and covered with a transparent sticky film to secure it) allowing it to measure different postures (eg, sitting, standing). Concurrent and criterion validity of the activPAL for sitting time measures, as well as for interruptions (breaks - defined as the number of transitions recorded from ‘‘sit/lie’’ posture to ‘‘stand’’) in SB have been established for pre-school children.
Timepoint [1] 322189 0
At baseline and at the end of the intervention (15 months post enrolment)
Secondary outcome [2] 322190 0
Physical activity over a usual week will be measured using Actigraph GT3X+ accelerometers. Actigraphs are small, light and unobtrusive devices worn on a belt around the waist and are the only accelerometer with established validity and utility in toddlers. These devices can collect very high-frequency raw data (30 Hz), which will be reintegrated and analysed according to best-practice methodologies at the time of analysis.
Timepoint [2] 322190 0
At baseline and at the end of the intervention (15 months post enrolment)
Secondary outcome [3] 322191 0
Parents/guardians will be asked to fulfil a questionnaire specifically designed for this study about demographic measures including: child age, sex, Aboriginal or Torres Strait Islander (ATSI), cultural and Linguistic Diversity (CALD); family education, income, ATSI, CALD and family structure.
Timepoint [3] 322191 0
At baseline.
Secondary outcome [4] 322192 0
Bone mineral density will be assessed using a portable ultrasound system. This will be collected with the child sitting on a chair with his/her leg extended and his/her foot resting in a relaxed position on the lap of the data collector.
Timepoint [4] 322192 0
At baseline and at the end of the intervention (15 months post enrolment)
Secondary outcome [5] 322193 0
For Cardiovascular health we will assess Blood Pressure and Retinal microvasculature by photographing both eyes of each participant with an ophthalmic fundus camera. Literature has shown that alterations in retinal microvasculature are associated with increased risk of cardiovascular disease. Retinal microvascular abnormalities are related to elevated concurrent blood pressure in adults and older people. In school-aged children, previous research as shown that both retinal arteriolar and venular calibers are associated with blood pressure; and that microvascular adaptations in childhood might influence cardiovascular health and disease from childhood onward. Our study takes an innovative approach by assessing retinal microvasculature in toddlers. Blood Pressure will be assessed with a pediatric sphygmomanometer. Previous research has also shown that higher levels of adiposity and lower levels of physical activity are predictors of elevated systolic blood pressure in pre-school children.
Timepoint [5] 322193 0
At baseline and at the end of the intervention (15 months post enrolment)
Secondary outcome [6] 322592 0
Educators demographics: Educators’ age, sex, qualifications, years of experience (in child care and in this service), level of training and experience in physical activity will be self-reported.
Timepoint [6] 322592 0
At baseline.
Secondary outcome [7] 322712 0
Educators self-effiacy : Educators from the intervention centres will also be asked to fulfil a questionnaire specifically designed for this study on their self-efficacy on delivering the intervention.
Timepoint [7] 322712 0
At baseline.

Eligibility
Key inclusion criteria
Apparently healthy toddlers aged 12 to 26-months at baseline will be eligible to participate if they attend the childcare service at least twice per week. All ethical consents will be obtained from the children’s parents or guardians.
Minimum age
12 Months
Maximum age
26 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be considered ineligible if they have a learning or physical disability, born very preterm (<29 weeks of gestation) or have a diagnosed medical or psychological condition that would affect the results of this study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
number containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis plan and power
Primary analysis. Analysis of the primary outcome will be conducted using a linear or generalized mixed model in SAS V9.2 (or higher). The mixed model will contain a random effect for time and service nested within group. Degrees of freedom will be altered manually in the code to adjust for the effect of clustering. These established procedures are well documented by Murray and have been used previously by our research institute to analyse a similar study in primary schools .No interim analyses are planned.
Secondary analyses. Mixed models will also be used to analyse the differences between treatment and control groups for all continuous secondary outcome variables.
Mediation and moderation analyses. Two types of analyses will be conducted to explore the theoretical assumptions of the intervention. First, hypothesised mediators of change in cognitive development (e.g., educator self-efficacy) will be examined using multilevel linear analysis and a product-of-coefficients test appropriate for cluster RCTs. Potential moderators of the intervention effects (e.g., child age and sex) will also be explored using multi-level modelling.
Sample size and power calculations. We anticipate an effect size of 0.5 for the between-group difference in cognitive development and an intraclass correlation (ICC) of 0.01–0.05. The proposed design has 16 services (8 per group) and 16 children completing per service. Allowing for participation of 18 eligible children with two dropouts per service [10%] gives a total sample size of 256. This reduces to an effective sample size of 200-254 (with rounding) based on ICCs of 0.05-0.01. The power to detect an effect size of 0.5 with these sample sizes ranges from 0.87-0.96 at an alpha level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293203 0
Government body
Name [1] 293203 0
Australian Research Council
Address [1] 293203 0
Australian Research Council
Level 2, 11 Lancaster Place,
Canberra Airport ACT 2609 AUSTRALIA
Country [1] 293203 0
Australia
Funding source category [2] 293204 0
University
Name [2] 293204 0
University of Wollongong
Address [2] 293204 0
University of Wollongong
Northfields Avenue,
Wollongong NSW 2522 AUSTRALIA
Country [2] 293204 0
Australia
Primary sponsor type
Individual
Name
Rute Santos
Address
University of Wollongong
Faculty of Social Sciences
Early Start Research Institute
Building 21 Room 214
Northfields Avenue
Wollongong, NSW 2522 Australia
Country
Australia
Secondary sponsor category [1] 292006 0
University
Name [1] 292006 0
University of Wollongong
Address [1] 292006 0
University of Wollongong
Northfields Avenue,
Wollongong NSW 2522 AUSTRALIA
Country [1] 292006 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294687 0
Social Sciences Human Research Ethics Committee, University of Wollongong
Ethics committee address [1] 294687 0
Ethics Unit, Research Services Office
University of Wollongong
Northfields Avenue
Wollongong, NSW 2522 Australia
Ethics committee country [1] 294687 0
Australia
Date submitted for ethics approval [1] 294687 0
02/06/2015
Approval date [1] 294687 0
16/10/2015
Ethics approval number [1] 294687 0
HE15/236

Summary
Brief summary
Our primary aim is to assess the effects of reducing sitting time during childcare on Executive Functions in a cluster randomised controlled trial in Australian toddlers from low socio-economic families. We hypothesise that at 15-month follow-up, toddlers in centres allocated to the intervention group will have improved their cognitive development by 0.5 SD more than toddlers in childcare centres randomly allocated to the control group. The secondary aims are to examine the effects of the intervention (i) on time spent in total sitting and bouts of sitting (ii) on time spent in total physical activity and moderate-to-vigorous physical activity (iii) on bone mineral density and (iv) and on cardiovascular health.
Trial website
Trial related presentations / publications
Santos, R., D. P. Cliff, S. J. Howard, S. L. Veldman, I. M. Wright, E. Sousa-Sa, J. R. Pereira and A. D. Okely (2016). ""GET-UP" study rationale and protocol: a cluster randomised controlled trial to evaluate the effects of reduced sitting on toddlers' cognitive development." BMC Pediatr 16(1): 182.
Public notes

Contacts
Principal investigator
Name 64666 0
Dr Rute Santos
Address 64666 0
University of Wollongong
Faculty of Social Sciences
Early Start Research Institute
Building 21 Room 214
Northfields Avenue
Wollongong, NSW 2522 Australia
Country 64666 0
Australia
Phone 64666 0
(+61)242218184
Fax 64666 0
Email 64666 0
rutes@uow.edu.au
Contact person for public queries
Name 64667 0
Dr Rute Santos
Address 64667 0
University of Wollongong
Faculty of Social Sciences
Early Start Research Institute
Building 21 Room 214
Northfields Avenue
Wollongong, NSW 2522 Australia
Country 64667 0
Australia
Phone 64667 0
(+61)242218184
Fax 64667 0
Email 64667 0
rutes@uow.edu.au
Contact person for scientific queries
Name 64668 0
Dr Rute Santos
Address 64668 0
University of Wollongong
Faculty of Social Sciences
Early Start Research Institute
Building 21 Room 214
Northfields Avenue
Wollongong, NSW 2522 Australia
Country 64668 0
Australia
Phone 64668 0
(+61)242218184
Fax 64668 0
Email 64668 0
rutes@uow.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary