Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000955011
Ethics application status
Approved
Date submitted
8/11/2010
Date registered
8/11/2010
Date last updated
12/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study of obesity and inflammation in children with asthma
Scientific title
The effect of a diet induced weight loss intervention on BMI Z-score, systemic and airway inflammation in obese children with asthma: The CIAO (Children Inflammation Asthma and Obesity) study
Secondary ID [1] 253041 0
Hunter New England Human Research Ethics Committee 09/05/20/5.08
Universal Trial Number (UTN)
U1111-1117-8038
Trial acronym
CIAO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood asthma 258604 0
Childhood Obesity 258605 0
Condition category
Condition code
Respiratory 258748 258748 0 0
Asthma
Diet and Nutrition 258749 258749 0 0
Obesity
Inflammatory and Immune System 258751 258751 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 10week diet-induced weight loss intervention. Participants receive weekly support from an Accredited Practising Dietitian. Face-to-face consults are for 30-60mins in weeks 0, 1,2, 4, 6, 8, and 10 with phone consults for 10mins on alternate weeks. Individual estimated energy requirements are reduced by 2000kj with the aim of weight loss.
Intervention code [1] 257568 0
Lifestyle
Comparator / control treatment
Participants randomised to the control group continue their usual lifestyle practices for a 10week period. After this control period, participants receive the exact diet induced weight loss intervention as described above.
Control group
Active

Outcomes
Primary outcome [1] 259607 0
Reduction in BMI Z-score
Timepoint [1] 259607 0
On completion of the intervention at 10 weeks
Primary outcome [2] 259608 0
Reduction in systemic inflammation (CRP) as measured by serum assay
Timepoint [2] 259608 0
On completion of the intervention at 10 weeks
Primary outcome [3] 259609 0
change in airway inflammation as measured by induced sputum cell counts
Timepoint [3] 259609 0
On completion of the intervention at 10 weeks
Secondary outcome [1] 266249 0
change in lung function measure by lung plethysmography
Timepoint [1] 266249 0
On completion of the intervention at 10 weeks

Eligibility
Key inclusion criteria
Doctor-diagnosed stable asthma; obesity (BMI z-score equal / greater than 1.64, equating to BMI percentile equal / greater than 95th) Aged 8-17yo
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inflammatory conditions e.g. lupus, cancer
Respiratory conditions other than asthma
unstable asthma
unexplained weight change in previous 3mths
cardiovascular / liver / renal disease
secondary obesity e.g. medication
pregancy
drug / alcohol use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment. An off-site statistician completed the randomisation and emailed the assigned group to the research officer. The research officer had no part in the randomisation process but was aware of which group the participant had been assigned as they were then to administer the dietary intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table generated by statistical software package
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants were randomised to either the control or treatment group. However, the control group continued on to the treatment phase after the control period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2009
Actual
30/07/2009
Date of last participant enrolment
Anticipated
Actual
20/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258017 0
Charities/Societies/Foundations
Name [1] 258017 0
Hunter Medical Research Institute Donor Grant
Country [1] 258017 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] 257211 0
Individual
Name [1] 257211 0
Dr Megan Jensen
Address [1] 257211 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country [1] 257211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260013 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 260013 0
Locked Bag 1
John Hunter Hospital
New Lambton NSW 2305
Ethics committee country [1] 260013 0
Australia
Date submitted for ethics approval [1] 260013 0
Approval date [1] 260013 0
01/06/2009
Ethics approval number [1] 260013 0
09/05/20/5.08

Summary
Brief summary
Obesity and asthma are two of the most common conditions affecting Australian children and adolescents. Epidemiological studies have indicated a link exists between obesity and asthma. Obesity is associated with chronic systemic inflammation. Given that asthma is characterised by chronic inflammation of the airways, we hypothesise that obesity is amplifying airway inflammation and impacting adversely on clinical asthma outcomes in children and adolescents.
Trial website
Trial related presentations / publications
Publication:
1. Jensen ME, Gibson PG, Collins CE, Hilton JM, Wood LG. Diet-induced weight loss in obese children with asthma: a randomized controlled trial. Clin Exp Allergy 2013; 43:775-84.

Conference Abstracts:
1. Jensen ME, Collins CE, Gibson PG, Hilton J, Wood LG. Obesity is associated with increased airway inflammation in children with asthma. Thoracic Society of Australia and New Zealand, Brisbane, March 2010.
2. Jensen ME, Collins CE, Gibson PG, Hilton J, Wood LG. Obesity Affects Airway Inflammation in Asthmatic Children. Dietetics Association of Australia Conference. Melbourne, May 2010
3. Jensen ME, Gibson PG, Collins CE, Hilton J, Wood LG. Body composition associations with systemic and airway inflammation in children and adolescents with asthma. Australia and New Zealand Obesity Society, Sydney, Australia, October 2010.
Public notes

Contacts
Principal investigator
Name 31884 0
A/Prof Lisa Wood
Address 31884 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 31884 0
Australia
Phone 31884 0
+61 2 40420147
Fax 31884 0
Email 31884 0
lisa.wood@newcastle.edu.au
Contact person for public queries
Name 15131 0
Dr Megan Jensen
Address 15131 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 15131 0
Australia
Phone 15131 0
+61 2 40420115
Fax 15131 0
+61 2 40420046
Email 15131 0
megan.jensen@newcastle.edu.au
Contact person for scientific queries
Name 6059 0
A/Prof Lisa Wood
Address 6059 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 6059 0
Australia
Phone 6059 0
+61 2 40420147
Fax 6059 0
+61 2 40420046
Email 6059 0
lisa.wood@newcastle.edu.au

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
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Documents added automatically
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