Preventing food allergy in infants with early introduction of complementary feeding

Research question: Does a behavioural intervention aimed at supporting parents/carers to introduce complementary feeding earlier reduce the likelihood that infants develop IgE-mediated food allergy? Background: About 1-in-20 UK pre-school children develop IgE-mediated food allergy. Avoiding food allergens is challenging leading to anxiety, impaired quality of life and cost-burden to families.

Recent randomised controlled trial (RCT) evidence suggests the current practice of delaying the introduction of foods to around 6-months (24-weeks) of age is causing food allergy.

However, one UK RCT did not significantly reduce food allergy with parents struggling to introduce large portions of six allergenic foods before 6-months. The Scandinavian PreventADALL RCT used smaller portions and was successful.

Objectives: 1) Co-produce a multi-level behavioural intervention with a diverse group of parents/carers and healthcare professionals (HCP) to support parents/carers with the introduction of allergenic foods into their infants diet from 17-weeks when developmentally ready (Work Package [WP] 1); 2) Assess the feasibility of this intervention (WP2); 3) Evaluate the effectiveness of this intervention in preventing IgE-mediated food allergies (typical presentation plus IgE-sensitisation plus/minus oral challenge) at 12-months within a cluster RCT (WP3); 4) Evaluate the cost-effectiveness of this intervention (WP4); 5) Optimise the intervention using a process analysis and plan its implementation (WP5).

Methods: WP1: Person-based approach, guided by the Medical Research Council guidance, to co-produce a complex digital intervention to support early complementary feeding.

This will specifically target barriers that parents/carers and HCPs identify and lever facilitators to successfully introduce complementary feeding.

We expect the intervention to include: (1) parent/carer website; (2) brief online training for HCP to support parents/carers with bite-sized information and signposting to the website; and (3) brief parent/carer support group (i.e., health visitors, community groups) training to facilitate the alignment of information.

WP2: The feasibility of the intervention will be assessed in four diverse UK areas to plan an effectiveness trial.

WP3&4: Intervention effectiveness and cost-effectiveness will be evaluated using a cluster RCT with 16 sites chosen to cover UK ethnic and socioeconomic diversity.

WP5: Work with collaborators/stakeholders to undertake a process analysis to understand how best to facilitate the dissemination and implementation of the intervention across the NHS.

Timelines for delivery: WP1: co-production, months 1-15 WP2: feasibility, months 1-27 WP3/4: effectiveness and cost-effectiveness, months 19-60/13-60 WP5: optimisation, dissemination and implementation, months 1-60 Anticipated impact and dissemination: If the new approach is successful, around 24,000 fewer children would develop food allergies across the UK each year reducing the impact of food allergy on families, NHS and wider society.

We would work with NHS Integrated Care Systems to introduce the intervention into routine clinical practice as an accessible website.

This would initially focus on North-East, Southcoast and Thames Valley as exemplar areas using an optimised version of the website and online training tools. Further implementation across the NHS could occur with minimal investment.

With our patient and public involvement (PPI) group, we will present the findings at relevant medical conferences, share with research participants and appropriate stakeholder groups and publish in peer reviewed medical journals.