Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000027819
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
6/01/2012
Date last updated
6/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lifestyle of our Kids study: Influences of physical activity and physical education on the psychophysical health of Australian children
Scientific title
Influences of physical activity and physical education on the psychophysical health of Australian children
Secondary ID [1] 273515 0
Nil
Universal Trial Number (UTN)
Trial acronym
LOOK study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Health 285488 0
Epidemiology 285489 0
Condition category
Condition code
Public Health 285677 285677 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical education delivered by specialist teachers, twice a week for 50 minutes each session, during a period of four primary school years, from grades 3 to 6. The physical education is based on an exploratory approach where children are challenged with movement tasks. The emphasis is on balance and gross motor skills as well as fine motor skills including eye hand coordination. There is also an emphaisis on engaging every child and enjoyment of the movement experience and de-emphasis on individual competition. The physical educators are specialist teachers from the Bluearth Foundation (www.bluearth.com), all trained teachers, who participate in the activities with the children.
Intervention code [1] 283830 0
Prevention
Comparator / control treatment
Physical education delivered by the classroom, non-specialist teachers
Control group
Active

Outcomes
Primary outcome [1] 286070 0
Primary Outcome 1: insulin resistance by homeostatic model of insulin resistance HOMA-IR, at three time points, each two years, at end of graede 2 (average age 8 years), end of grade 4 (age 10 years) and end of grade 6 (age 12 years)
Timepoint [1] 286070 0
At baseline grade 2, then grade 4, 6 following randomization of schools selected for intervention
Primary outcome [2] 286071 0
Primary Outcome 2: Obesity and overweight by dual energy X-ray absorptiometer (DEXA)
Timepoint [2] 286071 0
At baseline grade 2, then grades 4, 6 following randomization of schools selected for intervention
Primary outcome [3] 286072 0
Bone strength as measured by bone mineral density (DEXA) and bone geometry (periperal quantitative computed tomography (pQCT)
Timepoint [3] 286072 0
At baseline grade 2, then grades 4, 6 following randomization of schools selected for intervention
Secondary outcome [1] 295071 0
Academic performance as assessed by NAPLAN Australian Government tests of numeracy and literacy
Timepoint [1] 295071 0
At grade 3 and grade 5 when national tests are conducted
Secondary outcome [2] 295072 0
Eye-hand coordination by a ball throw and catch test
Timepoint [2] 295072 0
At baseline grade 2, then grades 4, 6 following randomization of schools selected for intervention

Eligibility
Key inclusion criteria
Free-living children in grade 2 of primary public schools in outer Canberra suburbs
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
chronic illness of any type or disability that prevents participation in vigorous 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)
Concealed envelopes with schools names were randomly selected and one by one alternatedly allocated to intervention or school group.
This occurred indepenently of any school, carried out by the LOOK research director and Data Bank manager.
The school was then notified of the decision. All schools accepted this procedure and their allocation.
The treatment was specialized physical education delivered twice weekly by specialist teachers (university qualified) provided by the Bluearth Foundation, a not for profit provider of physical activity programs in schools www.bluearth.org Outcomes were assessed by groups of researchers in several disciplines from the Australian National University (Statistics, metabolic physiology, psychology) and the Canberra Hospital (pathology, pediatrics, cardiology), University of Canberra (pedagogy) and Deakin University (skeletal development).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1.Selection of fully government funded schools outside the inner suburbs all situated in separate suburbs
2. Documentation of approval from Ethics committee, Government authority, school principal, parent and child.
3. Acceptance by school principal of participation whether or not allocated to intervention or control
3. Schools were randomly allocated to intervention or control group using school names in sealed envelopes, shuffling thoroughly, opening the envelopes, and alternately allocating each school to intervention and control
4. 830 upils in grade 2 of each school were the participants. This constituted 27% of all grade 2 pupils in the ACT fully government funded school system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
The random allocation was at the school level, not the subject level, this being necessary to prevent communication and potential influence of the treatment on the control group (intergroup contamination).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
850
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4760 0
2606
Recruitment postcode(s) [2] 4761 0
2607
Recruitment postcode(s) [3] 4762 0
2611
Recruitment postcode(s) [4] 4763 0
2615
Recruitment postcode(s) [5] 4764 0
2617
Recruitment postcode(s) [6] 4765 0
2902
Recruitment postcode(s) [7] 4766 0
2903
Recruitment postcode(s) [8] 4767 0
2904
Recruitment postcode(s) [9] 4768 0
2905
Recruitment postcode(s) [10] 4769 0
2906
Recruitment postcode(s) [11] 4770 0
2913
Recruitment postcode(s) [12] 4771 0
2606

Funding & Sponsors
Funding source category [1] 284308 0
Charities/Societies/Foundations
Name [1] 284308 0
Commonwealth Education Trust
Country [1] 284308 0
United Kingdom
Primary sponsor type
University
Name
ANU College of Medicine, Biology and the Environment
Address
Level 2, Peter Baume Building 42
Linnaeus Way
The Australian National University
Canberra ACT 0200
Country
Australia
Secondary sponsor category [1] 283252 0
Hospital
Name [1] 283252 0
The Canberra Hospital
Address [1] 283252 0
The Clinical Investigations Unit Canberra Hospital
Yamba Drive
Garran
ACT 2605
Country [1] 283252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286431 0
Australian Institute of Sport and Australian Sports Commission Ethics Committee
Ethics committee address [1] 286431 0
Ethics committee country [1] 286431 0
Australia
Date submitted for ethics approval [1] 286431 0
01/06/2005
Approval date [1] 286431 0
30/07/2005
Ethics approval number [1] 286431 0
20060606.

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

Contacts
Principal investigator
Name 33477 0
Address 33477 0
Country 33477 0
Phone 33477 0
Fax 33477 0
Email 33477 0
Contact person for public queries
Name 16724 0
Richard D Telford
Address 16724 0
Clinical Investigations Unit
The Canberra Hospital
Level 2 Bldg 1
Yamba Drive
Garran ACT 2605
Country 16724 0
Australia
Phone 16724 0
+61 2 62442811
Fax 16724 0
Email 16724 0
[email protected]
Contact person for scientific queries
Name 7652 0
Richard D Telford
Address 7652 0
Clinical Investigations Unit
The Canberra Hospital
Level 2 Bldg 1
Yamba Drive
Garran ACT 2605
Country 7652 0
Australia
Phone 7652 0
+61 2 62442811
Fax 7652 0
Email 7652 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
No additional documents have been identified.