Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000686808
Ethics application status
Approved
Date submitted
26/06/2012
Date registered
26/06/2012
Date last updated
26/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Energy balance and body composition in young children with cerebral palsy
Scientific title
Energy balance and body composition in young children with cerebral palsy
Secondary ID [1] 280735 0
Nil
Universal Trial Number (UTN)
U1111-1132-1220
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 286784 0
Condition category
Condition code
Neurological 287096 287096 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
This is an observational study. Children attended one appointment where various data collection measures were made, including details of gross motor functional ability, motor type and distribution of cerebral palsy, anthropometric measures, total energy expenditure, body composition measures, dietary intake and a clinical feeding evaluation. This appointment lasted approximately 1.5 - 2 hours. Children and parents completed additional data collection at home for total energy expenditure and dietary intake outcomes for the 10 days following the appointment.
This is a subset of a larger project investigating the growth, nutrition and physical activity of preschool aged chidlren with cerebral palsy (ACTRN 12611000616976).
Intervention code [1] 285161 0
Not applicable
Comparator / control treatment
Observation of same outcomes in a group of typically developing children.
Control group
Active

Outcomes
Primary outcome [1] 287418 0
Primary outcome 1: Differences in total energy expenditure measurements and energy requirements between children with cerebral palsy and typically developing children. This was assessed via an isotope dilution technique, in particular the doubly labelled water method.
Timepoint [1] 287418 0
Timepoint 1: cross-sectional, variables measured at appointment time and for the 10 days following the appointment.
Secondary outcome [1] 298105 0
Seconday outcome 1: Differences in body composition according to gross motor functional ability in the children with cerebral palsy and in comparison to typically developing children. Body composition was measured via isotope dilution techniques, either deuterim dilution or the doubly labelled water method. Gross motor functional ability was determined using the Gross Motor Function Classification System (GMFCS).
Timepoint [1] 298105 0
Timepoint 1: cross-sectional, variables measured at appointment time and for the 10 days following the appointment.
Secondary outcome [2] 298106 0
Secondary outcome 2: Relationships between energy intake, macronutrient intake and body composition according to gross motor functional ability in children with cerebral palsy and in comparison to typically developing children. Energy intake and macronutrient intake were determined from a three-day weighed food record kept by parents for their child. Body composition was measured via isotope dilution techniques, either deuterim dilution or the doubly labelled water method. Gross motor functional ability was determined using the Gross Motor Function Classification System (GMFCS).
Timepoint [2] 298106 0
Timepoint 2: cross-sectional, variables measured at appointment time and for the 10 days following the appointment.

Eligibility
Key inclusion criteria
Children with cerebral palsy:
* confirmed diagnosis of cerebral palsy by a physician
* aged between 1.4 and 5.1 years at time of assessment
* Any gross motor functional ability level
* residing in Queensland, Australia at the time of the study

Typically developing children:
*age matched
*residing in Queensland, Australia at the time of the study
Minimum age
1 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with cerebral palsy: if the child had a progressive or neurodegenerative lesion or a chromosomal or genetic abnormality known to affect growth or body composition.

Typically developing children: if the child had any condition or were taking any medications that altered energy metabolism or body composition

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
101
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285524 0
Government body
Name [1] 285524 0
National Health and Medical Research Council
Country [1] 285524 0
Australia
Primary sponsor type
Individual
Name
Jacqueline Walker
Address
Children's Nutrition Research Centre, School of Medicine, The University of Queensland, Old Milk Kitchen, Building 916, Cnr of Fourth and Back Rds, (Southern annexe of Edith Cavell Building ) Royal Children's Hospital, HERSTON, Qld, 4029
Country
Australia
Secondary sponsor category [1] 284360 0
University
Name [1] 284360 0
The University of Queensland
Address [1] 284360 0
The University of Queensland School of Medicine, 288 Herston Road, Herston QLD 4006
Country [1] 284360 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287535 0
Children's Health Services District Ethics Committee
Ethics committee address [1] 287535 0
Ethics committee country [1] 287535 0
Australia
Date submitted for ethics approval [1] 287535 0
19/11/2009
Approval date [1] 287535 0
08/12/2009
Ethics approval number [1] 287535 0
HREC/09/QRCH/124
Ethics committee name [2] 287536 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 287536 0
Ethics committee country [2] 287536 0
Australia
Date submitted for ethics approval [2] 287536 0
26/11/2009
Approval date [2] 287536 0
08/12/2009
Ethics approval number [2] 287536 0
2009001869

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

Contacts
Principal investigator
Name 34364 0
Address 34364 0
Country 34364 0
Phone 34364 0
Fax 34364 0
Email 34364 0
Contact person for public queries
Name 17611 0
Jacqueline Walker
Address 17611 0
Children's Nutrition Research Centre, School of Medicine, The University of Queensland, Old Milk Kitchen, Building 916, Cnr of Fourth and Back Rds, (Southern annexe of Edith Cavell Building ) Royal Children's Hospital, HERSTON, Qld, 4029
Country 17611 0
Australia
Phone 17611 0
+61 7 3646 1307
Fax 17611 0
Email 17611 0
[email protected]
Contact person for scientific queries
Name 8539 0
Jacqueline Walker
Address 8539 0
Children's Nutrition Research Centre, School of Medicine, The University of Queensland, Old Milk Kitchen, Building 916, Cnr of Fourth and Back Rds, (Southern annexe of Edith Cavell Building ) Royal Children's Hospital, HERSTON, Qld, 4029
Country 8539 0
Australia
Phone 8539 0
+61 7 3646 1307
Fax 8539 0
Email 8539 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
SourceTitleYear of PublicationDOI
EmbaseEnergy requirements in preschool-age children with cerebral palsy.2012https://dx.doi.org/10.3945/ajcn.112.043430
N.B. These documents automatically identified may not have been verified by the study sponsor.