INTENT Infant Feeding Clinical Trial Proves that Digital Methods are the Future for Participant Recruitment Efforts

More than 1,700 children from all 50 states will participate to help researchers learn more about early allergen feeding

MENLO PARK, Calif. , June 22, 2022 /PRNewswire/ -- SpoonfulONE, a revolutionary, science-backed line of nutritional products that makes feeding food allergens convenient, 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.

"Our partnership with the INTENT Study underscores our commitment to helping parents access cutting-edge research that addresses their families' needs. In our own research, parents have told us that food allergies are one of their top concerns when introducing solids to their babies. We also know that parents are interested in learning about clinical research on our platforms, second only behind doctors' offices, because of our established trust and relevance," said Lindsay Dills, Director of Strategic Programs of EHG P&P. "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. 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.

"We are extremely encouraged by the interest shown by parents during our recruitment phase. It is clear that parents have a deep interest in understanding food allergen introduction and novel ways to feed babies," said Dr. Wendy Sue Swanson, Chief Medical Officer, SpoonfulONE.

"The unique virtual nature of the study makes it convenient for parents and allows us to reach children in all 50 states. 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. This study adds to the company's ongoing published research, which is a major point of differentiation from other brands in the early allergen feeding category. Read more about SpoonfulONE research here.

About SpoonfulONE:

SpoonfulONE is a revolutionary, science-backed line of nutritional products that provide gentle daily exposure to 16 food allergens. Each serving of pediatrician-recommended SpoonfulONE includes the foods commonly associated with over 90% of food allergies. SpoonfulONE was invented by Before Brands and globally renowned pediatric allergist, Dr. Kari Nadeau, who also directs the Sean N. Parker Center for Allergy and Asthma Research at Stanford University's School of Medicine. The company headquarters in Menlo Park, CA, and has been backed since inception by Gurnet Point Capital along with a consortium of families from the food allergy community. In 2019, a global partnership was formed with Nestlé Health Science in which Nestlé acquired the non-U.S. rights to commercialize SpoonfulONE around the world. SpoonfulONE is sold at major retailers nationwide, on Amazon, and through SpoonfulONE.com.

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SOURCE SpoonfulONE