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Clinical Trial Shows Digital Methods Are Future for Participant Recruitment

SpoonfulONE’s direct-to-patient digital trial design allowed the company to recruit more than 1,700 children from all 50 states to participate in its latest clinical study.

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The following is an edited version of the original press release.

SpoonfulONE, a science-backed line of nutritional products that makes feeding food allergens convenient, has announced the successful completion of recruitment for their latest clinical study. The INTENT study is a first-of-its-kind completely digital trial conducted in partnership with the Duke Clinical Research Institute (DCRI) to evaluate whether feeding small amounts of common food allergens to babies over time can affect food tolerance and diet diversity. The study will examine parents’ experiences of early allergen introduction in infant feeding and explore the evidence showing SpoonfulONE as a science-backed solution to make it easy for families to follow new guidelines about early allergen introduction.

The study successfully recruited more than 1,700 babies from all 50 states, primarily through a strategic partnership with the Everyday Health Group Pregnancy & Parenting (EHG P&P) platform, which includes the brands BabyCenter and What to Expect. EHG P&P has a global network of digital platforms and online communities that reach millions of families around the world, including 91% of first-time expecting moms in the U.S.

“We leveraged our national network to reach parents of children who might be eligible and interested in the INTENT Study through our emails, apps, and community platforms,” says Lindsay Dills, director of strategic programs of EHG P&P. “We saw such a strong response rate that we were able to reach the enrollment goal ahead of schedule. Their interest demonstrates how valuable this research is to today’s parents.”

Using world-leading digital health expertise, the trial aims to meet parents where it’s most convenient for them—whether that’s at home or on the go. The app-based study enables parents to complete study questionnaires and e-diaries directly in the mobile application at their convenience and includes age-targeted educational content from leading pediatric experts.

“The unique virtual nature of the study makes it convenient for parents and allows us to reach children in all 50 states,” says Dr. Wendy Sue Swanson, chief medical officer, SpoonfulONE. “Despite the COVID-19 pandemic, we cannot forget about researching other chronic diseases and imperative prevention tactics. The food allergy epidemic is ongoing, and we will not sit idle as children continue to sensitize and develop food allergies. The INTENT study will bring us more data to help understand ways to reduce food allergy rates.”

The unique direct-to-patient digital trial design of the INTENT study will be presented as a late-breaking oral presentation at the European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress, taking place July 1-3, 2022. Additional enrollment details and select baseline characteristics of the study population will also be presented.

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