Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001791224
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
2/11/2018
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Baby EATS Study (Babies’ eating and allergen timing study)
Scientific title
Baby EATS Study (Babies’ eating and allergen timing study):
Parental uptake of infant feeding guidelines for prevention of allergy.
Secondary ID [1] 296159 0
none
Universal Trial Number (UTN)
U1111-1220-9557
Trial acronym
Baby EATS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 309780 0
Condition category
Condition code
Inflammatory and Immune System 308572 308572 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All parents will be provided with updated ASCIA infant feeding advice relating to allergy prevention. The link to the written advice on the ASCIA website will be sent via email to each family participating in the study.
Families will be randomised into two groups:
The intervention group will receive monthly SMS reminders to include common allergens in their infants’ diets from when they start solid foods (around 4-6 months of age) until the infant is 1 year of age.
The control group will receive standard care (i.e. no SMS messages).
The intervention will be administered via electronic data base.
Intervention code [1] 312489 0
Prevention
Comparator / control treatment
Upon enrollment, all parents will be provided with updated ASCIA infant feeding advice relating to allergy prevention.
The control group will receive standard care (i.e. the standard ASCIA infant feeding advice and no SMS messages).
Control group
Active

Outcomes
Primary outcome [1] 307531 0
The primary outcome will be inclusion of egg in the infant's diet, as assessed by a food frequency questionnaire
Timepoint [1] 307531 0
at 12 months of age.
Primary outcome [2] 307581 0
The second primary outcome will be inclusion of peanut in the infant's diet as assessed by a food frequency questionnaire
Timepoint [2] 307581 0
at 12 months of age.
Primary outcome [3] 307582 0
The third primary outcome will be inclusion of wheat in the infant's diet as assessed by a food frequency questionnaire
Timepoint [3] 307582 0
at 12 months of age.
Secondary outcome [1] 352238 0
Infantile diagnosis of eczema as assessed by standard International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire
Timepoint [1] 352238 0
at 12 months of age
Secondary outcome [2] 352366 0
Infantile history of IgE and non IgE mediated food allergy as assessed by standardised questionnaire developed specifically for this study.
Timepoint [2] 352366 0
at 12 months of age
Secondary outcome [3] 352367 0
Frequency of inclusion of common allergens (egg, peanut and wheat) in the diet as assessed by food frequency questionnaire
Timepoint [3] 352367 0
at 12 months of age
Secondary outcome [4] 352368 0
Parental reasons for not including common allergens (egg, peanut and wheat) in babies diets as assessed by standardised questionnaire developed specifically for this study.
Timepoint [4] 352368 0
at 12 months of age

Eligibility
Key inclusion criteria
we will recruit parents able to give informed consent, of term infants aged 0 to 6 months of age who have not yet started solid foods
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents of infants who have known major congenital abnormalities or health issues that could significantly affect feeding behaviour.
Parents of infants with IgE mediated food allergies diagnosed prior to study enrollment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analysis: The proportion of infants consuming allergens at home in the first year of life will be compared between the intervention group and control group using logistic regression with adjustment for potential confounding factors (e.g. gestation, sex, multiple birth).

Qualitative analysis: To examine parental attitudes, barriers and enablers to feeding allergens to their infants identified from the questionnaires, qualitative analysis will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/11/2018
Actual
Date of last participant enrolment
Anticipated
28/06/2019
Actual
Date of last data collection
Anticipated
30/12/2019
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11987 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 24134 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 300752 0
Charities/Societies/Foundations
Name [1] 300752 0
Womens and Childrens Hospital Foundation
Country [1] 300752 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
GPO Box 11060, Adelaide, 5001 SA
Country
Australia
Secondary sponsor category [1] 300288 0
None
Name [1] 300288 0
Address [1] 300288 0
Country [1] 300288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301529 0
Women's and Children's Health Network Human Research Ethics Committee [EC00197]
Ethics committee address [1] 301529 0
Ethics committee country [1] 301529 0
Australia
Date submitted for ethics approval [1] 301529 0
08/06/2018
Approval date [1] 301529 0
27/06/2018
Ethics approval number [1] 301529 0
HREC/18/WCHN/77

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

Contacts
Principal investigator
Name 87302 0
Dr Merryn Netting
Address 87302 0
Healthy Mothers, Babies and Children Theme: South Australian Health and Medical Research Institute, 72 King William St, Nth Adelaide SA 5006
Country 87302 0
Australia
Phone 87302 0
+61 8 812 84403
Fax 87302 0
Email 87302 0
[email protected]
Contact person for public queries
Name 87303 0
Merryn Netting
Address 87303 0
Healthy Mothers, Babies and Children Theme: South Australian Health and Medical Research Institute, 72 King William St, Nth Adelaide SA 5006
Country 87303 0
Australia
Phone 87303 0
+61 8 812 84403
Fax 87303 0
Email 87303 0
[email protected]
Contact person for scientific queries
Name 87304 0
Merryn Netting
Address 87304 0
Healthy Mothers, Babies and Children Theme: South Australian Health and Medical Research Institute, 72 King William St, Nth Adelaide SA 5006
Country 87304 0
Australia
Phone 87304 0
+61 8 812 84403
Fax 87304 0
Email 87304 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Data will be available in accordance with SAHMRI protocols. The specifics are yet to be decided by clinical trial steering committee.


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.