Approximately 6%–10% of adults carry food allergy labels. Many such labels are unverified and may be incorrect, contributing to delays in appropriate care, significant dietary restriction, anxiety and unnecessary use of emergency medications. Oral food challenges (OFCs) are the gold standard for confirming or excluding food allergy, but the current model of clinic-based challenges often has long wait times and logistical barriers. This study aims to investigate the feasibility and safety of home-based OFCs compared with standard in-clinic challenges in adults with negative skin-prick testing.

Food Challenge at HOme or in Medical Practice is a pilot multicentre randomised controlled trial enrolling 120 adults with reported food allergy labels and negative skin prick testing to the implicated food. Participants will be randomised 1:1 to undergo an OFC either at home or in-clinic. The study is designed to generate feasibility and preliminary safety data for home-based OFC, measured by the proportion of participants experiencing immune-mediated adverse events (AEs), compared with clinic-based OFC. Feasibility metrics (screening to recruitment ratio, protocol completion), non-immune AEs, protocol adherence and quality of life assessed using the Food Allergy Quality of Life Questionnaire-12 at baseline prior to OFC and 6 months post OFC will also be collected. Statistical analysis will include descriptive statistics, with comparisons between arms using risk differences and relative risks with 95% CIs.

The trial has received ethics approval from the Austin Health Human Research Ethics Committee (HREC/111750/Austin-2024). Findings will be disseminated through peer-reviewed publications and scientific meetings. Data will be presented in aggregated, de-identified form.

NCT06916819.

Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.

Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).

Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.

ACTRN12624000658516.