Ready. Set. Food! and ObvioHealth Complete Recruitment for Infant Food Allergy Study

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Dec 11, 2024, 12:00 ET

NEW YORK, Dec. 11, 2024 /PRNewswire/ -- Ready. Set. Food!, a leader in early allergen introduction solutions, and ObvioHealth, a global leader in digital clinical trial solutions, are proud to announce the successful early recruitment of 1,100 diverse participants for the Early Allergen System Experience (EASE) trial. Achieved two months ahead of schedule, this milestone marks a critical step toward advancing research on early allergen introduction to improve infant health outcomes and reduce healthcare costs.

The EASE trial explores how early and consistent allergen introduction can address longstanding challenges parents face, such as sustaining allergen feeding and managing associated costs. By leveraging ObvioHealth's innovative ObvioGo® platform, the trial efficiently reached its recruitment goal while reflecting real-world conditions for families introducing allergens at home.

"Ready. Set. Food! thoughtfully designed this trial over the course of years with the intention to fully enroll participants using a proven decentralized approach," said Sara Koors, EVP Research & HealthCare Strategy at Ready. Set. Food!. "With the support of ObvioHealth and 1nHealth, this goal was achieved in record time bringing us closer to fulfilling our mission of saving babies from life-threatening food allergies and enabling families to better understand the behaviors necessary to improve infant health."

This study milestone marks a significant step forward for Ready. Set. Food! as a whole. "We are particularly proud of the fact that over 30% of our total enrollment is representative of minority or mixed race participants emulating the real world consumer base that we serve," said Daniel Zakowski, CEO Ready. Set. Food!. "This is important because it furthers the awareness that all babies should have access to simple solutions that make early allergen introduction easy and sustainable."

Recruitment Powered by Digital Innovation

Recruitment for the EASE trial, which launched in March 2024, was driven by ObvioHealth's ObvioGo app, with 1nHealth's targeted digital strategies and expertise. These tools enabled seamless pre-screening, eConsent, and home-based participation, removing logistical barriers for families and creating a participant-friendly experience.

1nHealth's expertise in digital recruitment played a pivotal role in connecting eligible participants through targeted campaigns, ensuring the process was efficient and reflective of real-world conditions. By adopting this decentralized approach, Ready. Set. Food! achieved its recruitment target significantly ahead of schedule, demonstrating the scalability and effectiveness of digital clinical trial solutions.

Looking Ahead: Curavit's Role in Study Management

With the recruitment phase now complete, Curavit Clinical Research will oversee project management and clinical oversight for the next stages of the trial. Curavit, a "Virtual CRO" that designs and executes decentralized clinical trials by combining a virtual site with a full range of CRO services, will manage safety and regulatory compliance and will ensure seamless execution of study protocols and data collection. Additionally, Curavit will monitor the infant study population as they are introduced to the investigational food product and support parents throughout the study.

Commitment to EASE Trial Success

Ready. Set. Food!, ObvioHealth, and their partners remain committed to supporting participants and maintaining the highest standards of integrity and data quality throughout the trial. This commitment drives groundbreaking research with the potential to transform infant health outcomes and reduce the burden of food allergies.

"As the EASE trial progresses, the ObvioGo platform will remain integral to capturing high-quality, real-world data and maintaining participant engagement through seamless reporting tools," said Ivan Jarry, CEO of ObvioHealth. "This approach ensures robust data integrity and meaningful insights, advancing research that can transform infant health outcomes. We are proud to play a role in supporting groundbreaking research that has the potential to make a lasting impact on families worldwide."

SOURCE ObvioHealth