Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001185752
Ethics application status
Approved
Date submitted
21/10/2013
Date registered
29/10/2013
Date last updated
29/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Go Nuts! - Including non-allergic nuts in the diet of children with nut allergy
Scientific title
Does providing dietary advice improve the ingestion of non-allergic nuts in children with existing nut allergies? – a Randomised Controlled Trial.
Secondary ID [1] 283423 0
Nil known
Universal Trial Number (UTN)
U1111-1149-3599
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nut Allergy 290336 0
Condition category
Condition code
Inflammatory and Immune System 290736 290736 0 0
Allergies
Diet and Nutrition 290771 290771 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is a dietitian based written resource providing recipes and advice to help include non-allergic nuts into the diet. This is given after consent to the intervention group. The intervention group also recieve reminder text messages at monthly intervals commencing one month after consent, for 6 months (5 text messages).

Children are advised to eat the non-allergic nut, at least once per week, of an amount based on age:
1-6 years: 10g nuts =1/2 Tbs of nut paste
7-12 years: 20g nuts =1/4 cup nuts = 1 Tbs nut paste
13-18 years: 30g nuts = 1/3 cup nuts = 1.5 Tbs nut paste

The efficacy of the intervention will be determined 6 months after randomisation by a one month dietary recall of how many of the previous 4 weeks the weekly target has been met.
Intervention code [1] 288148 0
Lifestyle
Comparator / control treatment
Control group will have usual practice of verbal advice to introduce non-allergic nuts at home and a document on how to do this (intervention group will also recieve this).
Control group
Active

Outcomes
Primary outcome [1] 290735 0
To determine whether the provision of written dietary advice and reminders to parents of children with nut allergy leads to ingestion of non-allergic nuts into the diet when compared to current practice.

Assessed with monthly dietary recall at the end of the 6 month period, how many of the prior 4 weeks have nuts been ingested? has the weekly target been reached? This will be a phone questionnaire
Timepoint [1] 290735 0
6 months
Secondary outcome [1] 305114 0
To assess the changes in sensitisation to allergic and non-allergic nuts when nuts are ingested.

Children will have repeat skin prick testing at the end of the 6 month period.
Timepoint [1] 305114 0
6 months
Secondary outcome [2] 305115 0
To determine whether there is an increase in accidental exposure to allergic nuts in those who ingest non-allergic nuts.

Phone questionnaire at the end of the 6 month period of any accidental exposures or reactions. Parents also asked to immediately report any adverse reactions to any food.
Timepoint [2] 305115 0
6 months
Secondary outcome [3] 305116 0
To assess changes in quality of life of parents of children with nut allergy who ingest non-allergic nuts.

Quality of Life Survey FAQL-PB questionnaire at consent and at the end of 6 month period
Timepoint [3] 305116 0
6 months

Eligibility
Key inclusion criteria
Children between the ages of 12 months and 18 years with likely or known nut allergy as defined by positive challenge and/or positive skin prick test (>3mm)

Children will be required to have evidence that they are not allergic to at least one or more other nuts by negative skin prick testing, negative challenge or already tolerating the nut in normal dietary intake.
Minimum age
12 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or likely allergy to all nuts by positive skin prick testing or positive challenge.

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)
Potential recruits will be provided with the information sheet and consent form along with the usual written material on introducing non-allergic nuts at home. This will either be handed to them at clinic or Medical Day Unit appointment, or posted to them at home after a previous discussion in person.

Potential recruits will be contacted via phone after they have had a chance to read the information sheet and will be asked over the phone for verbal consent. If consented, both groups will also be asked to fill out and return the written consent form and a baseline quality of life questionnaire which will be included in the initial material. Baseline patient data will be collected through history over the phone and from the case notes.

Once consented, the patient details will be sent to administrative staff who will randomise the patient to either intervention or control by computer. They will post the intervention group the additional dietitian booklet. The investigators will not be aware of which group each patient is in when collecting follow up data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomised into two groups using a computer based randomisation program. Administrative staff will mail the treatment group a written booklet developed by the Immunology/Allergy Dietician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2013
Actual
Date of last participant enrolment
Anticipated
31/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 7478 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 288147 0
Hospital
Name [1] 288147 0
Women's and Children's Hospital Immunology/Allergy Department
Country [1] 288147 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital Allergy/Immunology Department
Address
Women's and Children's Hosital
72 King William Road
North Adelaide
SA
5006
Country
Australia
Secondary sponsor category [1] 286865 0
None
Name [1] 286865 0
Address [1] 286865 0
Country [1] 286865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290065 0
WCHN Human Ethics Research Committee
Ethics committee address [1] 290065 0
Level 2 Samuel Way Building
72 King William Rd
North Adelaide
SA
5006
Ethics committee country [1] 290065 0
Australia
Date submitted for ethics approval [1] 290065 0
Approval date [1] 290065 0
23/09/2013
Ethics approval number [1] 290065 0
HREC/13/WCHN/112

Summary
Brief summary
Children who have nut allergies must avoid that nut in their diet, but this can be difficult to achieve. Young children may be unable to tell different nuts apart due to similarities in appearance. Nuts can also be present in baked goods, dips, muesli bars and other foods, requiring reading of the label. Some children are also allergic to more than one nut adding complexity to this process. Having a child who is allergic to nuts can also cause anxiety around social events such as parties and school camps and can have a significant impact on quality of life of both the parents and child.

Due to the difficult nature of avoiding one type of nut, in the past it has been common for parents to avoid all nuts, either on advice of their doctor, or for their own peace of mind. More recently however, it appears that there may be benefits from having ongoing exposure to non-allergic nuts in our diets. Totally avoiding nuts we are not allergic to may increase the risk of developing an allergy to this nut later on.

Parents of children with nut allergy are now being advised to include non-allergic nuts in their child’s diet on an ongoing basis. To ingest the suggested amount of nut as often as required can be difficult. In this study, we will provide to the intervention group, a resource which aims to help parents achieve this. It contains a series of recipes and suggestions for including nuts in every day foods to provide an alternative to eating whole nuts. This group will also receive monthly text messages reminding them to include non-allergic nuts in the diet. We also hope that this will increase knowledge surrounding the intake of nuts, reduce anxiety and help to improve quality of life for these families.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43750 0
Dr Melissa Norman
Address 43750 0
Women's and Children's Hospital
72 King William Rd
North Adelaide
SA
5006
Country 43750 0
Australia
Phone 43750 0
+61 8 8161 7000
Fax 43750 0
Email 43750 0
[email protected]
Contact person for public queries
Name 43751 0
Dr Melissa Norman
Address 43751 0
Women's and Children's Hospital
72 King William Rd
North Adelaide
SA
5006
Country 43751 0
Australia
Phone 43751 0
+61 8 8161 7000
Fax 43751 0
Email 43751 0
[email protected]
Contact person for scientific queries
Name 43752 0
Dr Melissa Norman
Address 43752 0
Women's and Children's Hospital
72 King William Rd
North Adelaide
SA
5006
Country 43752 0
Australia
Phone 43752 0
+61 8 8161 7000
Fax 43752 0
Email 43752 0
[email protected]

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

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Documents added automatically
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