Synopsis

The HealthNuts study of 5,300 children is the world’s first comprehensive population-based study of food allergy with an objective measurement of true food allergy. The study will enable researchers to better understand the natural history of allergic disorders including food allergy, asthma, eczema and hay fever and the risk factors for developing these conditions in the first six years of life. The study will have important implications for clinical guidelines and public health policy.

Wave 1 – data collected from whole sample (questionnaire and Skin Prick Test (SPT) at immunisation centre). Participants who recorded any SPT wheal size greater than the negative control were invited to participate in a food challenge
Wave 2 – data collected from whole sample (questionnaire only). In addition, anyone food allergic at wave 1 food challenge or who indicated the presence of new food allergy symptoms since wave 1 were offered a food challenge
Wave 3 – data collected from whole sample (questionnaire and allergy assessment – Royal Children’s Hospital or home visit). In addition, anyone food allergic when last seen, had a positive SPT in wave 3 or who indicated the presence of new food allergy symptoms since last seen were offered a food challenge.

Summary

Study name HealthNuts
Current principal investigator/s Professor Katie Allen
Postal address HealthNuts Study, Gastro and Food Allergy, MCRI, Royal Children’s Hospital, Flemington Rd, Parkville, VIC 3052
Phone +613 8341 6266
Email health.nuts@mcri.edu.au 
Primary Institution Murdoch Children’s Research Institute
Collaborating Institution/s

The Royal Children’s Hospital; The University of Melbourne

Major funding sources

National Health and Medical Research Council
IIhan Food Allergy Foundation
AnaphylaxiStop
Australian Egg Corporation Pty.
US Department of Defense

Study website https://www.mcri.edu.au/research/projects/healthnuts
Key reference Osborne, N.J., Koplin, J.J., Martin, P.E., Gurrin, L.C., Thiele, L., Tang, M.L., Ponsonby, A-L., Dharmage, S.C. and Allen, K.J., for HealthNuts Study Investigators. (2010). The HealthNuts population-based study of paediatric food allergy: validity, safety and acceptability. Clin Exp Allergy, 40(10): 1516-22
Are data available to others outside study team? Yes, on request, with provision of an analysis plan and approval from investigator group.
Study focus Understanding the natural history of allergic disorders including food allergy, asthma, eczema and hay fever.
Sampling frame 12-month-old infants presenting for routine scheduled vaccination at local government-led immunisation clinics across Melbourne, Australia.
Year commenced 2007
Commencement sample 5300 
Annual attrition rate 19% at age 4 years 
Intergenerational? No 
Imaging No 
Linkage School Entrant Health Questionnaire
Medicare
VPDC
Australian Immunisation Register (AIR)
Biosamples? Blood
Faeces
Saliva
Newborn Screening (Guthrie) card
Ethics approval This project only (Specific consent)
Future research related to this project (Extended consent)
Any future research (Unspecified consent)

Waves

Wave Year Age (mean, range) Eligible sample
1  2007 – 2010 1 year (12.6 months)

5300 (whole cohort)
1026 (clinic/food challenge)

2  2011 – 2014 4 years

4289 (81.3%) (whole cohort)
540 (clinic/food challenge)

3  2013 6 years

To be determined (ongoing) (whole cohort)
300 (clinic/food challenge)