Ready. Set. Food!, a company focused on early allergen introduction solutions, and ObvioHealth, specializing in digital clinical trial solutions, have announced the completion of recruitment for the Early Allergen System Experience (EASE) trial. The trial, which aims to explore the impact of early and consistent allergen introduction on infant health outcomes and healthcare costs, reached its target of 1,100 participants two months ahead of schedule.
The EASE trial is designed to address challenges parents face in sustaining allergen feeding and managing related costs. By using ObvioHealth's ObvioGo platform, the trial seeks to replicate real-world conditions for families introducing allergens at home. The study's rapid recruitment underscores the potential of decentralized approaches in clinical research.
Digital Recruitment Strategies
The recruitment phase, initiated in March 2024, leveraged ObvioHealth's ObvioGo app, complemented by 1nHealth's digital strategies. These tools facilitated pre-screening, eConsent, and home-based participation, reducing logistical barriers for families. 1nHealth's targeted campaigns were crucial in connecting eligible participants, ensuring an efficient and representative recruitment process. Over 30% of the enrolled participants represent minority or mixed-race backgrounds.
Curavit's Role in Study Management
With recruitment concluded, Curavit Clinical Research will manage project management and clinical oversight for the subsequent trial stages. Curavit, employing a virtual CRO model, will oversee safety, regulatory compliance, study protocol execution, and data collection. They will also monitor the infant study population as they are introduced to the investigational food product and support parents throughout the study.
Commitment to Trial Success
Ready. Set. Food!, ObvioHealth, and their partners are focused on maintaining data quality and participant support throughout the trial. The EASE trial is designed to generate insights that could transform infant health outcomes and reduce the burden of food allergies.
Ivan Jarry, CEO of ObvioHealth, stated that the ObvioGo platform will continue to capture high-quality, real-world data and maintain participant engagement through reporting tools. This approach aims to ensure data integrity and advance research that can positively impact families globally.
