Pilot Study Comparing Educational Approaches for Early Introduction and Continued Feeding of Allergenic Foods in Infants

What this Trial Is About

Researchers are exploring whether early feeding of potentially allergenic foods to infants can be increased using either educational materials alone or combined with additional in-person support. This pilot study focuses on infants aged 4 to 11 months and aims to guide pediatricians and allergists on how best to support new parents in introducing allergenic foods. The study involves two groups to compare these educational approaches and their effectiveness in promoting early allergen introduction. Participants are randomly divided into two groups one receives three educational modules about food allergy and infant nutrition spaced one month apart, while the other receives the same materials plus three in-person or live video education sessions for further discussion and questions. Both groups are required or encouraged to introduce known allergenic foods at home and record intake, with supervised feeding sessions at the research clinic during the first three months. The intervention group must complete at least one supervised feeding, while the standard group has the option and must complete one if allergenic foods have not been introduced by month three. Throughout the six-month study, participants complete quizzes after each educational module, and infants undergo assessments including blood draws, skin tape strips, transepidermal water loss measurements, and stool collections at study start and end. Lactating mothers may provide nipple swabs and breast milk samples. Dietary intake is tracked via questionnaires, and anxiety and knowledge surveys are completed before and after the study. Researchers measure the age and frequency of allergenic food introduction as primary outcomes, with ongoing safety and adherence monitoring during the study period.

Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants