Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
253041
0
Hunter New England Human Research Ethics Committee 09/05/20/5.08
Query!
Universal Trial Number (UTN)
U1111-1117-8038
Query!
Trial acronym
CIAO
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Childhood asthma
258604
0
Query!
Childhood Obesity
258605
0
Query!
Condition category
Condition code
Respiratory
258748
258748
0
0
Query!
Asthma
Query!
Diet and Nutrition
258749
258749
0
0
Query!
Obesity
Query!
Inflammatory and Immune System
258751
258751
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
257568
0
Lifestyle
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
259607
0
Reduction in BMI Z-score
Query!
Assessment method [1]
259607
0
Query!
Timepoint [1]
259607
0
On completion of the intervention at 10 weeks
Query!
Primary outcome [2]
259608
0
Reduction in systemic inflammation (CRP) as measured by serum assay
Query!
Assessment method [2]
259608
0
Query!
Timepoint [2]
259608
0
On completion of the intervention at 10 weeks
Query!
Primary outcome [3]
259609
0
change in airway inflammation as measured by induced sputum cell counts
Query!
Assessment method [3]
259609
0
Query!
Timepoint [3]
259609
0
On completion of the intervention at 10 weeks
Query!
Secondary outcome [1]
266249
0
change in lung function measure by lung plethysmography
Query!
Assessment method [1]
266249
0
Query!
Timepoint [1]
266249
0
On completion of the intervention at 10 weeks
Query!
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
Query!
Minimum age
8
Years
Query!
Query!
Maximum age
17
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table generated by statistical software package
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
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.
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
30/07/2009
Query!
Actual
30/07/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
20/10/2011
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
258017
0
Charities/Societies/Foundations
Query!
Name [1]
258017
0
Hunter Medical Research Institute Donor Grant
Query!
Address [1]
258017
0
Level 3, John Hunter Hospital
Lookout Rd
New Lambton NSW Australia 2305
Query!
Country [1]
258017
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
A/Prof Lisa Wood
Query!
Address
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Query!
Country
Australia
Query!
Secondary sponsor category [1]
257211
0
Individual
Query!
Name [1]
257211
0
Dr Megan Jensen
Query!
Address [1]
257211
0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Query!
Country [1]
257211
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260013
0
Hunter New England Human Research Ethics Committee
Query!
Ethics committee address [1]
260013
0
Locked Bag 1
John Hunter Hospital
New Lambton NSW 2305
Query!
Ethics committee country [1]
260013
0
Australia
Query!
Date submitted for ethics approval [1]
260013
0
Query!
Approval date [1]
260013
0
01/06/2009
Query!
Ethics approval number [1]
260013
0
09/05/20/5.08
Query!
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.
Query!
Trial website
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
31884
0
A/Prof Lisa Wood
Query!
Address
31884
0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Query!
Country
31884
0
Australia
Query!
Phone
31884
0
+61 2 40420147
Query!
Fax
31884
0
Query!
Email
31884
0
[email protected]
Query!
Contact person for public queries
Name
15131
0
Dr Megan Jensen
Query!
Address
15131
0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Query!
Country
15131
0
Australia
Query!
Phone
15131
0
+61 2 40420115
Query!
Fax
15131
0
+61 2 40420046
Query!
Email
15131
0
[email protected]
Query!
Contact person for scientific queries
Name
6059
0
A/Prof Lisa Wood
Query!
Address
6059
0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Query!
Country
6059
0
Australia
Query!
Phone
6059
0
+61 2 40420147
Query!
Fax
6059
0
+61 2 40420046
Query!
Email
6059
0
[email protected]
Query!
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.
Download to PDF