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Trial registered on ANZCTR


Registration number
ACTRN12620000025932
Ethics application status
Approved
Date submitted
17/10/2019
Date registered
17/01/2020
Date last updated
17/01/2020
Date data sharing statement initially provided
17/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
SmartStartAllergy - a novel SMS and smartphone based application to monitor infants starting solid foods and support implementation of infant feeding guidelines
Scientific title
A randomised trial of an SMS and smartphone based application to promote introduction of peanut in infants by 12 months of age.
Secondary ID [1] 299577 0
None
Universal Trial Number (UTN)
Trial acronym
SSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut allergy 314852 0
Condition category
Condition code
Inflammatory and Immune System 313192 313192 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group receive SMS when their infants are 6 of age to ask if their child has started eating solid foods (6 months only). If the response is yes, a second message asks whether they have eaten foods with peanut, and then a third message asks if they have had an allergic reaction to any food.

At 9 months of age, the first SMS sent is dependent on the responses provided at 6 months. If the participant had not eaten foods with peanut at 6 months of age, the first question is "Since we contacted you 3 months ago, has *name of child* eaten foods with peanut?" If the participant had already eaten peanut at 6 months, the first question at 9 months is "Since we contacted you 3 months ago, has *name of child* had an allergic reaction to any food?".

Participants who reply "No" to the question about eating foods with peanut at 6 or 9 months of age receive a further SMS with the following advice: "Allergy prevention guidelines suggest giving peanut paste before 12 months. See bit.ly/_NAS or speak to your GP."

The shortened URL link (bit.ly/_NAS) to the website www.preventallergies.org.au, which contains publicly available resources for infant feeding and allergy prevention.

Participants will also receive a personalised link to complete a web-based questionnaire regarding introduction of common food allergens, any allergic reactions that have occurred, and risk factors for food allergy in the infant.

Participant engagement with SmartStartAllergy is assessed by determining the proportion of participants who reply to the SMS questions at each time point. The number of website visits to www.preventallergies.org.au that are directed via the shortened URL, which is not publicly promoted outside this project, is also recorded on a monthly basis.
Intervention code [1] 315832 0
Prevention
Intervention code [2] 316434 0
Treatment: Devices
Comparator / control treatment
The control group will only receive SMS at 12 months of age to assess the primary outcome for infants currently following standard care. The control group will also receive a link to complete the web-based questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 321703 0
Proportion of infants who have eaten foods containing peanut, as assessed by parent response to SMS question "Has <<name of child>> eaten foods with peanut?"
Timepoint [1] 321703 0
12 months of age
Secondary outcome [1] 375966 0
Proportion of infants with parent-reported allergic reaction to any food, as assessed by parent response to SMS question "Has <<name of child>> had an allergic reaction to any food?"
Timepoint [1] 375966 0
12 months of age
Secondary outcome [2] 375967 0
Proportion of infants who have introduced common allergenic solid foods, as assessed by parent completed study-specific web based questionnaire asking which foods their child has eaten with option for yes/no response to cow's milk, egg, fish, peanut, sesame, soy, tree nuts and wheat.
Timepoint [2] 375967 0
12 months of age
Secondary outcome [3] 375968 0
Proportion of infants with parent-reported allergic reaction to peanut, as assessed by parent completed study-specific web based questionnaire.
Timepoint [3] 375968 0
12 months of age
Secondary outcome [4] 375969 0
Proportion of infants with parent-reported allergic reaction to egg, as assessed by parent completed study-specific web based questionnaire.
Timepoint [4] 375969 0
12 months of age

Eligibility
Key inclusion criteria
Infants attending a participating general practice in Western Australia who have a valid mobile phone number registered with the practice. Parents are the respondents to the SMS and questionnaire; they are included where their mobile phone number is listed as the primary mobile phone contact for their child with the general practice. Only one parent of a child will receive the study intervention as it is only the first listed mobile phone contact for the infant that is used for the study.
Minimum age
6 Months
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants whose parents have previously opted out of receiving SMS from the participating practice. Infants older than 6 months at the time of study commencement. Parents who have not provided a contact mobile phone number for their infant at the practice will be excluded.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation 4:1 intervention:control, stratified according to participating practice. Within each practice, sequential allocation to intervention or control group according to defined ratio (4 intervention, then 1 control participant) is performed automatically by the software program without involvement of the investigators.
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
Chi-squared test for comparison of proportions in 2 groups; level of significance of p<0.05 for the primary outcome

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304061 0
Charities/Societies/Foundations
Name [1] 304061 0
Perth Children's Hospital Foundation
Address [1] 304061 0
15 Hospital Avenue
Nedlands WA 6009
Country [1] 304061 0
Australia
Primary sponsor type
Individual
Name
Michael O'Sullivan
Address
Immunology Department
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 304257 0
None
Name [1] 304257 0
Address [1] 304257 0
Country [1] 304257 0
Other collaborator category [1] 280992 0
Individual
Name [1] 280992 0
Alan Leeb
Address [1] 280992 0
Illawarra Medical Centre
229 Illawarra Cres South
Ballajura WA 6066
Country [1] 280992 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304552 0
Universtiy of Western Australia HREC
Ethics committee address [1] 304552 0
35 Stirling Highway
Crawley WA 6009
Ethics committee country [1] 304552 0
Australia
Date submitted for ethics approval [1] 304552 0
Approval date [1] 304552 0
22/02/2018
Ethics approval number [1] 304552 0
RA/4/1/9326

Summary
Brief summary
SmartStartAllergy (SSA) is a novel SMS and smartphone-based application currently integrated with general practices to promote and monitor the introduction of allergenic foods. We hypothesise that parents of infants who receive SMS when their child is 6 and 9 months of age, from their general practice that is using SSA, are more likely to feed their child peanut paste before they turn 1 compared with those who do not receive the messages.

Parents are randomised to receive automated SMSs from their general practice when their child is 6, 9 and 12 months old, or to only receive SMSs at 12 months (control group). A questionnaire, accessed via link from SMS, collects additional information about infant feeding and food allergy.

Proportions of infants who have introduced peanut by 12 months of age, based on responses from parents to an SMS question, will be compared between the two groups.
Trial website
http://www.smartstartallergy.com.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97358 0
Dr Michael O'Sullivan
Address 97358 0
Immunology Consultant
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 97358 0
Australia
Phone 97358 0
+61864562222
Fax 97358 0
Email 97358 0
michael.o'sullivan@health.wa.gov.au
Contact person for public queries
Name 97359 0
Dr Jessica Metcalfe
Address 97359 0
Immunology Clinical Research Coordinator
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 97359 0
Australia
Phone 97359 0
+61864562222
Fax 97359 0
Email 97359 0
immunology.research@health.wa.gov.au
Contact person for scientific queries
Name 97360 0
Dr Michael O'Sullivan
Address 97360 0
Immunology Consultant
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
Country 97360 0
Australia
Phone 97360 0
+61864562222
Fax 97360 0
Email 97360 0
michael.o'sullivan@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5391 0
Study protocol
Citation [1] 5391 0
Link [1] 5391 0
Email [1] 5391 0
immunology.research@health.wa.gov.au
Other [1] 5391 0
Attachment [1] 5391 0
Type [2] 5392 0
Ethical approval
Citation [2] 5392 0
Link [2] 5392 0
Email [2] 5392 0
immunology.research@health.wa.gov.au
Other [2] 5392 0
Attachment [2] 5392 0
Summary results
No Results