Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000422921
Ethics application status
Approved
Date submitted
21/04/2011
Date registered
21/04/2011
Date last updated
12/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of risk factors for obesity in children with asthma
Scientific title
A study investigating the risk factors for obesity in children with asthma: The Obesity Risk factors in Children with Asthma (ORCA) study.
Secondary ID [1] 260057 0
Nil
Universal Trial Number (UTN)
Trial acronym
ORCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood asthma 265718 0
Childhood obesity 265719 0
Condition category
Condition code
Respiratory 265860 265860 0 0
Asthma
Diet and Nutrition 265861 265861 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross-sectional study. Patients referred to the Pediatric Sleep Unit, John Hunter Hospital for a polysomnography (sleep study) will be recruited. In addition to the polysomnography recording, data will be collected from eligible participants, including: resting energy expenditure (indirect calorimetry), dietary and physical activity data (questionnaires), lung function (spirometry), and levels of appetite hormones (blood sample). The assessment session will take approximately 1.5hrs.
Intervention code [1] 264472 0
Not applicable
Comparator / control treatment
Children with asthma will be compared to children without asthma.
Control group
Active

Outcomes
Primary outcome [1] 266618 0
appetite hormone levels: leptin and ghrelin as measured by plasma assay
Timepoint [1] 266618 0
at time of collection (cross-sectional design)
Primary outcome [2] 266619 0
resting energy expenditure as measured by indirect calorimetry
Timepoint [2] 266619 0
at time of collection (cross-sectional design)
Primary outcome [3] 266620 0
sleep duration and sleep efficiency as measured by polysomnograpy
Timepoint [3] 266620 0
at time of collection (cross-sectional design)
Secondary outcome [1] 276101 0
Nil
Timepoint [1] 276101 0
Nil

Eligibility
Key inclusion criteria
age 7-17yo
non-obese (BMI z-score <1.96)
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
obesity
respiratory disease other than asthma
medications that alter sleep
cardiovascular / liver/ renal disease
congenital malformations or conditions that may affect sleep

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2011
Actual
21/03/2011
Date of last participant enrolment
Anticipated
Actual
31/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264947 0
Charities/Societies/Foundations
Name [1] 264947 0
Hunter Medical Research Institute Donor Grant
Country [1] 264947 0
Australia
Primary sponsor type
Individual
Name
A/Prof Lisa Wood
Address
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 264044 0
Individual
Name [1] 264044 0
Dr Megan Jensen
Address [1] 264044 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country [1] 264044 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266907 0
Hunter New England Human Researach Ethics Committee
Ethics committee address [1] 266907 0
Ethics committee country [1] 266907 0
Australia
Date submitted for ethics approval [1] 266907 0
Approval date [1] 266907 0
09/09/2010
Ethics approval number [1] 266907 0
10/08/18/5.04

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

Contacts
Principal investigator
Name 32530 0
A/Prof Lisa Wood
Address 32530 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 32530 0
Australia
Phone 32530 0
+61 2 40420147
Fax 32530 0
+61 2 40420046
Email 32530 0
[email protected]
Contact person for public queries
Name 15777 0
Megan Jensen
Address 15777 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 15777 0
Australia
Phone 15777 0
+61 2 40420115
Fax 15777 0
+61 2 40420046
Email 15777 0
[email protected]
Contact person for scientific queries
Name 6705 0
Lisa Wood
Address 6705 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 6705 0
Australia
Phone 6705 0
+61 2 40420147
Fax 6705 0
+61 2 40420046
Email 6705 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.