Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000851561
Ethics application status
Approved
Date submitted
22/07/2015
Date registered
14/08/2015
Date last updated
17/12/2019
Date data sharing statement initially provided
6/03/2019
Date results provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of improved diet on the risk of asthma attacks in children (the ImpACt study)
Scientific title
Evaluating the efficacy of improved diet quality to reduce the risk of exacerbations in children with asthma in a randomised controlled trial.
Secondary ID [1] 287106 0
None
Universal Trial Number (UTN)
U1111-1172-2802
Trial acronym
ImpACt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 295633 0
Condition category
Condition code
Respiratory 295912 295912 0 0
Asthma
Inflammatory and Immune System 295913 295913 0 0
Normal development and function of the immune system
Diet and Nutrition 295914 295914 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be allocated an age-appropriate high fruit and vegetable diet (that is, according to the Australian Dietary Guidelines for their age group; for 2-3 years: 3.5 combined serves per day; for 4-8 years: 6 combined serves per day; and for 9-11 years: 7 combined serves per day) and provided with weekly food hampers containing a variety of fruit and vegetable products for 6 months. Participants will be asked to limit juice intake to no more than 1/2 cup per day. No other changes will be made to the diet. Participants and their carer will have a 1 hour face-to-face consult with a dietitian at baseline, 2 weeks, 4 weeks, 3 and 6 months, where they will be counselled on their assigned dietary intervention, including the provision of recipes and ideas to help the child adhere to the dietary recommendations. Between weeks 4 and 26, the participant's carer will receive fortnightly calls from a dietitian to address any issues relating to dietary adherence.
Intervention code [1] 292355 0
Lifestyle
Intervention code [2] 292462 0
Treatment: Other
Comparator / control treatment
The control group will continue with their usual consumption of fruits and vegetables, and will receive a hamper containing foods consistent with their usual intake. To ensure they are adhering to their usual diet, participants and their carer will have a face-to-face consult with a dietitian at baseline, 2 weeks, 4 weeks, 3 and 6 months, and will receive fortnightly calls from a dietitian between weeks 4 and 26. The child and their family will be provided with an information brochure on general healthy eating for their age and a personalised consultation with a dietitian at the end of the trial.
Control group
Active

Outcomes
Primary outcome [1] 295589 0
Time to first asthma exacerbation requiring medical intervention (unscheduled GP visit, emergency department presentation, hopsitalisation, or oral corticosteroids), reported by parent and/or medical records.
Timepoint [1] 295589 0
At first occurrence of an exacerbation, that is, any point during the 6 month study period.
Secondary outcome [1] 315903 0
The rate of asthma exacerbations requiring medical intervention (unscheduled GP visit, emergency department presentation, hopsitalisation, or oral corticosteroids), over the 6-month study period, reported by parent and/or medical records
Timepoint [1] 315903 0
Assessed per-patient-month of follow-up, i.e. at 6-months or study finalisation (whichever comes first)
Secondary outcome [2] 315904 0
The change in plasma antioxidants over the 6-month period
Timepoint [2] 315904 0
Assessed at baseline, 3 months and 6 months.
Secondary outcome [3] 315905 0
The change in plasma and faecal short chain fatty acids over the 6-month period
Timepoint [3] 315905 0
Assessed at baseline, 3 months and 6 months.
Secondary outcome [4] 315906 0
The rate of viral infections, reported by parents and confirmed by polymerase chain reaction (PCR) analysis of nasal swabs, over the 6-month period
Timepoint [4] 315906 0
Assessed per-patient-month of follow-up, i.e. at 6-months or study finalisation (whichever comes first)
Secondary outcome [5] 315907 0
The change in asthma control over the 6-month period, using the childhood asthma control test (cACT)
Timepoint [5] 315907 0
Assessed weekly from randomisation for 6 months
Secondary outcome [6] 315908 0
The severity and duration of asthma exacerbations, documented using the Asthma Flare-up Diary for Young Children (ADYC) and the childhood asthma control test (cACT).
Timepoint [6] 315908 0
Assessed at each event during the 6 month study period.
Secondary outcome [7] 315909 0
The severity and duration of upper respiratory tract infections, documented by parents on the Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) and the Canadian Acute Respiratory Infection & Flu Scale (CARFIS).
Timepoint [7] 315909 0
Assessed at each event during the 6 month study period.
Secondary outcome [8] 315910 0
Innate antiviral response of rhinovirus-infected peripheral blood monocytes (PBMCs) compared to untreated PBMCs at each time-point, including the release of interferons measured via ELISA or cytometric bead array.
Timepoint [8] 315910 0
At baseline, 3 months and 6 months
Secondary outcome [9] 315911 0
The change in HDAC/ HAT activity in nuclear and cytosolic extracts from peripheral blood monocytes and granulocytes
Timepoint [9] 315911 0
At baseline, 3 months and 6 months

Eligibility
Key inclusion criteria
Physician diagosed asthma
History of one or more exacerbations in the past 6 months, or at least two in the past 12 months that resulted in medical intervention
usual F&V intake (assessed over the past week) below the current Australian Dietary Guidelines for their age group
Minimum age
3 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic respiratory condition other than asthma; clinically important medical illness, including psychiatric or behavioural disorders and chronic medical conditions requiring regular treatment with medications, likely to affect participation; chronic use of anti-inflammatory medications, e.g. low-dose systemic corticosteroids; unable or unwilling to modify diet; diagnosed intestinal disorders such as irritable bowel syndrome, inflammatory bowel disease and coeliac disease

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)
Randomisation will be carried out by an independent statistician and the participant's group allocation and number will be provided to the research dietitian on enrolment, who will assign the necessary dietary recommendations (unblinded).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out using a computerised random number generator, in variable block sizes, stratified by age group and gender. The randomisation service will be managed by an independent statistician at the Hunter Medical Research Institute.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/08/2015
Actual
28/09/2015
Date of last participant enrolment
Anticipated
Actual
12/12/2017
Date of last data collection
Anticipated
Actual
22/06/2018
Sample size
Target
78
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4059 0
Hunter Medical Research Institute - New Lambton Heights
Recruitment hospital [2] 4060 0
John Hunter Children's Hospital - New Lambton

Funding & Sponsors
Funding source category [1] 291665 0
Other Collaborative groups
Name [1] 291665 0
Hunter Medical Research Institute Donor grants
Country [1] 291665 0
Australia
Primary sponsor type
Individual
Name
A/Prof Lisa Wood
Address
Centre for Asthma & Respiratory Disease,
Level 2, West Wing, HMRI Building
Care of: the University of Newcastle
University Drive, Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 290339 0
University
Name [1] 290339 0
The University of Newcastle
Address [1] 290339 0
University Drive, Callaghan
NSW 2305
Country [1] 290339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293194 0
Hunter New England Health Research Ethics Committee
Ethics committee address [1] 293194 0
Ethics committee country [1] 293194 0
Australia
Date submitted for ethics approval [1] 293194 0
17/06/2015
Approval date [1] 293194 0
08/07/2015
Ethics approval number [1] 293194 0
15/06/17/4.03
Ethics committee name [2] 293195 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 293195 0
Ethics committee country [2] 293195 0
Australia
Date submitted for ethics approval [2] 293195 0
10/07/2015
Approval date [2] 293195 0
15/07/2015
Ethics approval number [2] 293195 0
H-2015-0256

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

Contacts
Principal investigator
Name 58850 0
Prof Lisa Wood
Address 58850 0
Centre for Asthma & Respiratory Disease,
Level 2, West Wing, HMRI Building
Care of: the University of Newcastle
University Drive, Callaghan
NSW 2308
Country 58850 0
Australia
Phone 58850 0
+61 2 40420147
Fax 58850 0
Email 58850 0
[email protected]
Contact person for public queries
Name 58851 0
Bronwyn Berthon
Address 58851 0
Centre for Asthma & Respiratory Disease,
Level 2, West Wing, HMRI Building
Care of: the University of Newcastle
University Drive, Callaghan
NSW 2308
Country 58851 0
Australia
Phone 58851 0
+61 240420116
Fax 58851 0
Email 58851 0
[email protected]
Contact person for scientific queries
Name 58852 0
Lisa Wood
Address 58852 0
Centre for Asthma & Respiratory Disease,
Level 2, West Wing, HMRI Building
Care of: the University of Newcastle
University Drive, Callaghan
NSW 2308
Country 58852 0
Australia
Phone 58852 0
+61 2 40420147
Fax 58852 0
+61 2 40420046
Email 58852 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no plan to share IPD for this trial


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.