Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000616976
Ethics application status
Approved
Date submitted
23/05/2011
Date registered
16/06/2011
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Date results information initially provided
10/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, longitudinal study of growth, nutrition and sedentary behaviour in young children with cerebral palsy to measure growth, dietary intake, physical activity, participation, health resource use and quality of life
Scientific title
A prospective, longitudinal study of growth, nutrition and sedentary behaviour in young children with cerebral palsy to measure growth, dietary intake, physical activity, participation, health resource use and quality of life
Secondary ID [1] 262202 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 267896 0
Condition category
Condition code
Musculoskeletal 268045 268045 0 0
Other muscular and skeletal disorders
Neurological 268075 268075 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Growth (height, length, segmental length), body composition (percent body fat) nutrition (3 day weighed food record), physical activity (physical activity monitor), health outcomes (questionnaire), participation (questionnaire) and health resource use (questionnaire) will be measured at 18months of age, 3 years of age and 5 years of age.
Intervention code [1] 264605 0
Not applicable
Comparator / control treatment
Comparisons will be made between children in different Gross Motor Function Classification System (GMFCS) categories.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266787 0
Linear Growth
). Height or length will be measured to the last completed millimetre with a portable stadiometer/ length measuring board (Shorr Productions, LLC, Maryland, USA). Knee height and upper-arm length will be measured with an anthropometer (Holtain Ltd, Dyfed, UK). Height estimates will be predicted from knee height and upper arm length using published validated equations.
Timepoint [1] 266787 0
At 18 months, 3 years and 5 years of age.
Primary outcome [2] 266788 0
Gross Motor Function Classification System (I - V)
Timepoint [2] 266788 0
At 18 months, 3 years and 5 years of age.
Primary outcome [3] 266789 0
Body Composition (percent body fat) determined from measures of total body water using the dueterium dilution technique.
Timepoint [3] 266789 0
At 18 months, 3 years and 5 years of age.
Secondary outcome [1] 276389 0
Habitual time spent sedentary:
The time that children spend sedentary in their own free-living environment will be measured using the ActiGraph GT3M accelerometer (Shalimar, FL) over a 3 day period.
Timepoint [1] 276389 0
At 18 months, 3 years and 5 years of age.
Secondary outcome [2] 276390 0
Dietary intake:
Usual dietary intake will be determined using a three day weighed food record.
Timepoint [2] 276390 0
At 18 months, 3 years and 5 years of age.
Secondary outcome [3] 276391 0
Feeding ability:
Oral motor and swallowing function will be assessed using a number of measures obtained from a parent completed feeding questionnaire, direct observation during a clinical feeding evaluation of a regular meal and from ratings derived from the video taped clinical feeding evaluation. Feeding dysfunction will be rated according to the Scedule for Oral Motor Assessment and the Dysphagia Disorders Survey
Timepoint [3] 276391 0
At 18 months, 3 years and 5 years of age.
Secondary outcome [4] 276392 0
Participation:
Participation will be determined using parent-report on the domains of self-care, mobility and social functioning using the scaled scores (rasch analysed) of the Pediatric Evaluation of Disability Inventory (PEDI).
Timepoint [4] 276392 0
At 18 months, 3 years and 5 years of age.
Secondary outcome [5] 276393 0
Resource use and the direct costs of treatment:
In order to determine the relationship between motor prognosis and resource use, medical and allied health resource use and the direct costs of treatment will be monitored and compared to outcomes with adjustment for confounders such as disease severity using cost and consequences analysis.
Timepoint [5] 276393 0
At 18 months, 3 years and 5 years of age.
Secondary outcome [6] 276394 0
Quality of life:
Parent perception of QOL will be assessed using the condition specific tool, CP QOL-child, from 4 years of age.
Timepoint [6] 276394 0
5 years of age

Eligibility
Key inclusion criteria
All Queensland born children diagnosed with CP, born between 1st September 2006 and 31st December, 2009. We define CP as a group of permanent disorders of movement and posture that are attributed to non-progressive disturbances that occurred in the developing foetal or infant brain. The characteristic signs are spasticity, movement disorders, muscle weakness, ataxia and rigidity.
Minimum age
18 Months
Maximum age
62 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with a progressive or neurodegenerative lesion will be excluded from the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2009
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
21/03/2014
Date of last data collection
Anticipated
Actual
11/03/2015
Sample size
Target
240
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 267108 0
Government body
Name [1] 267108 0
National Health and Medical Research Council
Country [1] 267108 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Children's Nutrition Research Centre
Discipline of Paediatrics and Child Health
University of Queensland
3rd Floor Foundation Building
Royal Children's Hospital
Herston
Queensland 4029
Country
Australia
Secondary sponsor category [1] 264188 0
Hospital
Name [1] 264188 0
Royal Children's Hospital
Address [1] 264188 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Discipline of Paediatrics and Child Health
3rd Floor Foundation Building
Royal Children's Hospital
Herston
Queensland 4029
Country [1] 264188 0
Australia
Other collaborator category [1] 252008 0
University
Name [1] 252008 0
University of Virginia
Address [1] 252008 0
Kluge Children's Rehabilitation Centre
University of Virginia
2270 Ivy Road (Rt. 250 West)
Charlottesville, VA 22903
Country [1] 252008 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267086 0
Children's Health Service District Ethics Committee
Ethics committee address [1] 267086 0
Lvl 3 Foundation Buidling
Royal Children's Hospital
Herston
Queensland 4029
Ethics committee country [1] 267086 0
Australia
Date submitted for ethics approval [1] 267086 0
Approval date [1] 267086 0
24/02/2009
Ethics approval number [1] 267086 0

Summary
Brief summary
This population based longitudinal study of children with CP from the age of 18 months to 5 years will permit the first comprehensive evaluation of the impact of functional attainment and lifestyle factors (dietary intake and habitual physical activity) on growth, body composition and nutritional status. This study will enable more accurate prediction of the early natural history of nutritional and growth problems in young children with CP linked to activity levels and health outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32626 0
Dr Kristie Bell
Address 32626 0
Children's Nutrition Research Centre,
Child Health Research Centre,
Level 6 Centre for Child Health Research,
University of Queensland,
62 Graham Street
South Brisbane QLD 4101
Country 32626 0
Australia
Phone 32626 0
+ 61 7 3069 7451
Fax 32626 0
Email 32626 0
[email protected]
Contact person for public queries
Name 15873 0
Dr Kristie Bell
Address 15873 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Discipline of Paediatrics and Child Health
3rd Floor Foundation Building
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 15873 0
Australia
Phone 15873 0
+61 7 3636 5537
Fax 15873 0
Email 15873 0
[email protected]
Contact person for scientific queries
Name 6801 0
Dr Kristie Bell
Address 6801 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Discipline of Paediatrics and Child Health
3rd Floor Foundation Building
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 6801 0
Australia
Phone 6801 0
+61 7 3636 5537
Fax 6801 0
Email 6801 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be publicly available. All published data has been reported as a group.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
634Study protocol    https://bmcpublichealth.biomedcentral.com/articles... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 35. WALKER, J. L., BELL, K. L., BOYD, R. N. & DAVI... [More Details] 336948-(Uploaded-06-12-2018-12-26-53)-Journal results publication.pdf
Study results articleYes WALKER, J. L., BELL, K. L., STEVENSON, R. D., WEIR... [More Details] 336948-(Uploaded-06-12-2018-12-24-57)-Journal results publication.pdf
Study results articleYes BENFER, K. A., WEIR, K. A., BELL, K. L., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-26-53)-Journal results publication.pdf
Study results articleYes WALKER, J. L., BELL, K. L., STEVENSON, R. D., WEIR... [More Details] 336948-(Uploaded-06-12-2018-12-28-26)-Journal results publication.pdf
Study results articleYes OFTEDAL, S., BELL, K. L., DAVIES, P. S., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-31-16)-Journal results publication.pdf
Study results articleYes BENFER, K. A., WEIR, K. A., BELL, K. L., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-33-31)-Journal results publication.pdf
Study results articleYes BENFER, K. A., WEIR, K. A., BELL, K. L., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-35-07)-Journal results publication.pdf
Study results articleYes BENFER, K. A., WEIR, K. A., BELL, K. L., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-36-40)-Journal results publication.pdf
Study results articleYes OFTEDAL, S., DAVIES, P. S., BOYD, R. N., STEVENSON... [More Details] 336948-(Uploaded-06-12-2018-12-37-48)-Journal results publication.pdf
Study results articleYes OFTEDAL, S., DAVIES, P. S., BOYD, R. N., STEVENSON... [More Details] 336948-(Uploaded-06-12-2018-12-39-08)-Journal results publication.pdf
Study results articleYes BENFER, K. A., WEIR, K. A., WARE, R. S., DAVIES, P... [More Details] 336948-(Uploaded-06-12-2018-12-40-25)-Journal results publication.pdf
Study results articleYes BENFER, K. A., WEIR, K. A., BELL, K. L., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-41-51)-Journal results publication.pdf
Study results articleYes BENFER, K. A., WEIR, K. A., BELL, K. L., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-43-02)-Journal results publication.pdf
Study results articleYes KEAWUTAN, P., BELL, K. L., OFTEDAL, S., DAVIES, P.... [More Details] 336948-(Uploaded-06-12-2018-12-44-16)-Journal results publication.pdf
Study results articleYes KEAWUTAN, P., BELL, K. L., OFTEDAL, S., WARE, R. S... [More Details] 336948-(Uploaded-06-12-2018-12-45-20)-Journal results publication.pdf
Study results articleYes KEAWUTAN, P., BELL, K. L., OFTEDAL, S., DAVIES, P.... [More Details] 336948-(Uploaded-06-12-2018-12-46-22)-Journal results publication.pdf
Study results articleYes KEAWUTAN, P., BELL, K. L., OFTEDAL, S., DAVIES, P.... [More Details] 336948-(Uploaded-06-12-2018-12-47-17)-Journal results publication.pdf
Study results articleYes WEIR, K. A., BELL, K. L., CARISTO, F., WARE, R. S.... [More Details] 336948-(Uploaded-06-12-2018-12-48-37)-Journal results publication.pdf
Study results articleYes WALKER, J. L., BELL, K. L., BOYD, R. N. & DAVIES, ... [More Details] 336948-(Uploaded-06-12-2018-12-49-46)-Journal results publication.pdf
Study results articleYes OFTEDAL, S., BELL, K. L., DAVIES, P. S., WARE, R. ... [More Details] 336948-(Uploaded-06-12-2018-12-51-04)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDifferences in body composition according to functional ability in preschool-aged children with cerebral palsy.2015https://dx.doi.org/10.1016/j.clnu.2014.02.007
EmbaseThe Eating and Drinking Ability Classification System in a population-based sample of preschool children with cerebral palsy.2017https://dx.doi.org/10.1111/dmcn.13403
EmbaseThe use of bioelectrical impedance analysis to estimate total body water in young children with cerebral palsy.2013https://dx.doi.org/10.1016/j.clnu.2012.10.005
N.B. These documents automatically identified may not have been verified by the study sponsor.