Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001028695
Ethics application status
Approved
Date submitted
11/08/2014
Date registered
24/09/2014
Date last updated
20/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a pre-school day with less sitting result in acute health benefits in 4-5 year old children?
Scientific title
Acute effects of a ''reduced-sitting preschool day'' on energy expenditure, musculoskeletal health, and executive function in pre-schoolers: a random cross-over whole room calorimeter study.
Secondary ID [1] 284829 0
Nil
Universal Trial Number (UTN)
U1111-1158-1746
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 292214 0
Obesity 292830 0
Sedentary Behaviour 292831 0
Condition category
Condition code
Public Health 292550 292550 0 0
Health promotion/education
Diet and Nutrition 293146 293146 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is Phase III of a proposed five-phase study. This phase will test the differences in energy expenditure between the typical and “Stand more-Sit less” day at childcare using the UOW Whole Room Calorimeter. This information will then be used to examine the feasibility, acceptability, and potential efficacy of a 6-month pilot intervention to promote less total and prolonged sitting in childcare services (Phase IV).
This study plans to address the high levels of sitting found among pre-schoolers during their time at child care, which has the potential to substantially improve the health and developmental outcomes of the children.
Assuming energy intake remains constant, this increase would be enough to alter energy balance and potentially prevent unhealthy weight gain. This project will also provide important feasibility data for another follow-up study which has the potential to improve musculoskeletal outcomes – an important outcome that has not yet been examined in any age group - and behavioural self-regulation skills, which are better predictors of school readiness than IQ or entry-level literacy or numeracy skills.

Details of Visits:
Visit 1 – Initial familiarisation with calorimeter room and a discussion with parents and children to start the process of consent. The child will take home an information book which parents will read to them several times to familiarise them both with the study.
After given consent height/weight and musculoskeletal assessments and posture analysis will be conducted.

Visit 2 – (typical pre-school day-50% of time sitting). Participants will arrive 20 mins prior to entering the calorimeter at 9am after having eaten a standardised breakfast at 7am. Executive function assessments will be conducted prior to entering and immediately upon leaving the calorimeter. A standard morning tea will be consumed around 1.5 hrs after entering the calorimeter and lunch will be provided at the completion of the protocol (after 2.5 hrs in the calorimeter). Participants will then spend 50% of their time in the calorimeter sitting, undertaking tasks that they normally would as part of a typical day at pre-school.
After this visit, children will do the muskuloskeletal and executive function tests again.
After this visit children will wear a Sensewear and actigraph for 48 hours.

Visit 3 – (modified pre-school day-25% of time sitting). This will be identical to Visit 2 except that participants will sit for 50% less time and replace this with 50% more time spent in light-intensity activity (such as standing) based on the modifications suggested by staff in Phase 2 of the preliminary study, and confirmed by the researchers listed in this application as developmentally appropriate.

Musculoskeletal and executive function assessments will be conducted prior to entering and immediately upon leaving the calorimeter at both Visits 2 and 3. The child’s parent will be able to view their child in the Calorimeter through a window and communicate with them via intercom if necessary. The child will be constantly supervised and in contact with a trained qualified Childcare educator, and a research student from the University of Wollongong.

Before entering the calorimeter on Visits 2 and 3, children will be fitted with an Actigraph and Geneactiv accelerometer on the wrist and hip and an activPal on their leg. Participants will be free to leave the calorimeter at any time. They will be shown how they can open the door by themselves, and all measurements will be in the presence of a research assistant (an early childhood trainer educator who can observe and communicate with the participant at all times via an external window and intercom).

Visits 2 and 3 will each last 2.5 hours – the equivalent of half a
day in childcare.
Each visit is seperated by 1 week.

As there is a possibility that participants may compensate for sitting less and engaging in more light-intensity PA by being less active afterwards, we will ask participants to wear an Actigraph and a Sensewear mini arm band for 48 hours after Visit 2 and 3. The Sensewear Mini combines accelerometry with four additional physiological sensors (heat flux sensor, galvanic skin response, skin temperature, and a near-body ambient temperature) and will be used to assess Energy Expenditure over the 48 hour period immediately following Visit 3. To measure if participants compensate for less sitting by increasing their energy intake, we will ask parents of the participants to complete 2 x 24hr dietary recalls over the same 48 hr period. We will use the same instrument as used in the Australian Health Survey 2011-2013. Parents will be asked to list all the food and drink their child has consumed in each of the 24 hour periods, from midnight to midnight on each of the days after their child’s visit to the calorimeter. This will allow the estimation of total intake of food, beverages, food energy, nutrients and non-nutrient food components consumed by their child.
Parents will also be asked to fill in a one page log that indicates when the accelerometer was worn or not worn (eg removed for bathing). See Appendix D Activity monitor log ver1 3-09-13 . An information sheet about the accelerometers will be given to the parent. See Appendix C Activity monitor info sheet ver1 3-09-13 .

Appendices D and C are available in the 'Attachments' section of ANZCTR registration form.
Intervention code [1] 289621 0
Lifestyle
Intervention code [2] 290087 0
Behaviour
Comparator / control treatment
We will compare our intervention with visit 2 – (typical pre-school day-50% of time sitting). Participants will arrive 20 mins prior to entering the calorimeter at 9am after having eaten a standardised breakfast at 7am. Musculoskeletal, height and weight, and executive function assessments will be conducted prior to entering and immediately upon leaving the calorimeter. A standard morning tea will be consumed around 1.5 hrs after entering the calorimeter and lunch will be provided at the completion of the protocol (after 2.5 hrs in the calorimeter). Participants will then spend 50% of their time in the calorimeter sitting, undertaking tasks that they normally would as part of a typical day at pre-school.
Control group
Active

Outcomes
Primary outcome [1] 292426 0
Energy expenditure measured in calorimeter room on visit 2 and 3. The calorimeter is a room around the size of a child’s bedroom which measures the oxygen consumption and carbon dioxide production of the person inside. From these measurements we are able to accurately measure energy expenditure.
48 hours after visit 2 and 3 energy expenditure will be measured using a Sensewear
Timepoint [1] 292426 0
Energy expenditure will be measured during visit 2 and 3 in the calorimeter room and 48h after visit 2 and 3.
Primary outcome [2] 292564 0
Time spent in sedentary behaviour and total physical activity (minutes in light, moderate, vigorous physical activity (LMVPA) as measured by Actigraph GT3X+, ActivPal and GeneActiv accelerometers.
Timepoint [2] 292564 0
During visit 2 and 3 in the calorimeter room and 48h after visit 2 and 3
Secondary outcome [1] 308908 0
Musculoskeletal health (flexibility, strength, balancing), this will be measured using an incliniometer, goniometer and dynamometer.
Timepoint [1] 308908 0
Baseline will be measured on visit 1. And follow-up after visit 2 and visit 3.
Secondary outcome [2] 308910 0
Executive function
This will be measured using three games.
Inhibition: Fish-Shark go/no-go task
Working memory: Mr. Ant (sticker memory game on iPad)
Shifting: Dimensional Change Card Sort Task
Timepoint [2] 308910 0
This outcome is assessed before and after visit 2 and 3
Secondary outcome [3] 309229 0
Posture, will be assessed using video cameras and markers which will be placed on the back of the child.
Timepoint [3] 309229 0
On visit 1
Secondary outcome [4] 309230 0
Diet, using weighed food diary log. This food diary log will be kept by the child's parent.
Timepoint [4] 309230 0
48 hours after visit 2 and 3
Secondary outcome [5] 309231 0
Height and weight
Timepoint [5] 309231 0
Baseline

Eligibility
Key inclusion criteria
Pre-school children aged 4 to 5 years, free from disorders of mobility
Minimum age
4 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Color blind, mobility disorder

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)
Participants will be recruited through the 11 Illawarra Area Child Care services (throughout the Illawarra and South Coast) that were involved in Phases I and II of this project. Participants will also be recruited through an email to all staff of the University of Wollongong.
Once interested parents have responded they will be contacted via phone or email. They will then be screened to ensure that children participating are free from disorders of mobility that would affect their participation, and from disorders that might alter their Energy Expenditure.
The order of visits 2 and 3 will be randomly allocated to each participant to minimize any ordering effect. As such, for some children, they will complete the modified preschool day prior to the typical pre-school day and will undertake the subsequent measurements to determine if any compensation occurred after the visit. Both rooms in the calorimeter will be used in this study. One will be set up for the typical pre-school day visit and the other for the modified pre-school day visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedure used- Visit 2 and 3 were written on paper and randomly selected from a box. This box was out of the line of sight of the person selecting the names.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the average weight of a child aged 3-5 years (20.6kg) and the EE (Energy Expenditure) values for sedentary and light-intensity PA (Physical Activity) from our previous whole room calorimeter study in this age group, a sample size of 30 participants will provide 85% power to detect a difference in EE of 13 kcals (with a SD of 20 kcals and a within subject correlation of 0.3) between a typical and modified half-day at preschool (3.5hrs). To quantify the differences between the two conditions, a repeated measures ANOVA or mixed model approach will be used adjusting for covariates such as weight, age, and accounting for the paired nature of the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2014
Actual
26/08/2014
Date of last participant enrolment
Anticipated
Actual
26/01/2016
Date of last data collection
Anticipated
Actual
26/02/2016
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289534 0
University
Name [1] 289534 0
University of Wollongong, Illawarra Medical Research Institute
Country [1] 289534 0
Australia
Primary sponsor type
University
Name
University of Wollongong, Illawarra Health and Medical Research Institute
Address
University of Wollongong
Northfields Ave
NSW 2522, Australia
Country
Australia
Secondary sponsor category [1] 288221 0
None
Name [1] 288221 0
Address [1] 288221 0
Country [1] 288221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291271 0
The Social Sciences Human Research Ethics Committee, University of Wollongong
Ethics committee address [1] 291271 0
Ethics committee country [1] 291271 0
Australia
Date submitted for ethics approval [1] 291271 0
Approval date [1] 291271 0
28/04/2014
Ethics approval number [1] 291271 0
HE13/406
Ethics committee name [2] 291272 0
South Eastern Sydney Local Health District Clinical Ethics Committee
Ethics committee address [2] 291272 0
Ethics committee country [2] 291272 0
Australia
Date submitted for ethics approval [2] 291272 0
Approval date [2] 291272 0
Ethics approval number [2] 291272 0
HE13/406

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 111 111 0 0
/AnzctrAttachments/366563-Appendix A PIS Calorimeter Ver5 02-07-14.docx
Attachments [2] 112 112 0 0
/AnzctrAttachments/366563-Appendix B Consent Calorimeter ver4 04-06-14.docx
Attachments [3] 113 113 0 0
/AnzctrAttachments/366563-Appendix C Activity monitor info sheet ver1 3-09-13.docx
Attachments [4] 114 114 0 0
/AnzctrAttachments/366563-Appendix D Activity monitor log ver1 3-09-13.docx

Contacts
Principal investigator
Name 49310 0
Prof Tony Okely
Address 49310 0
School of Education. Building 22, room 106. Northfields Avenue, University of Wollongong. NSW 2533
Country 49310 0
Australia
Phone 49310 0
+61 02 42214641
Fax 49310 0
Email 49310 0
[email protected]
Contact person for public queries
Name 49311 0
Yvonne Ellis
Address 49311 0
School of Education. Building 22, room 106. Northfields Avenue, University of Wollongong. NSW 2533
Country 49311 0
Australia
Phone 49311 0
+61 02 42215486
Fax 49311 0
Email 49311 0
[email protected]
Contact person for scientific queries
Name 49312 0
Tony Okely
Address 49312 0
School of Education. Building 22, room 106. Northfields Avenue, University of Wollongong. NSW 2533
Country 49312 0
Australia
Phone 49312 0
+61 02 42214641
Fax 49312 0
Email 49312 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
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Documents added automatically
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