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
Locked Bag 1
John Hunter Hospital
New Lambton NSW 2305
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
Obesity and asthma are two of the most common conditions affecting Australian children and adolescents. Obesity is higher in children with asthma compared to children without asthma. We propose that children with asthma may have a higher prevalence of risk factors for obesity, namely increased sleep disturbance, poor dietary and physical activity patterns and altered resting energy expenditure.
Trial website
Trial related presentations / publications
Jensen ME, Gibson PG, Collins CE, Hilton JM, Wood LG. Sleep, diet, activity, and metabolic outcomes in children with and without asthma: a cross-sectional study. American Thoracic Society, San Diego CA, USA. May 2014. Am J Resp Crit Care Med 189: A4582. Poster presentation.
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
Dr 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
A/Prof 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]

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No Supporting Document Provided



Results publications and other study-related documents

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