Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study
Stanford University
Summary
The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone or with educational materials and additional in-person support opportunities. This study will help guide what types of support pediatricians and allergists give to new parents.
Description
This 6 month study will randomly assign caretaker/child dyads into two groups; 50% will be assigned to the intervention group, the other 50% to the standard-of-care group. Using the foods of each families home and culture, participants in the standard-of-care group will be instructed through 3 packets metered one month apart of scientifically supported written, audio and video materials that are widely available to the general public. The intervention group will receive the same educational materials at the same time points as the standard-of-care group. The intervention group will additionall…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for both Infant and Caregiver/Parent Participants * Born term (37 weeks - 41 weeks gestation) * Infants with or without a family history of allergic disease * Infants with or without mild to moderate eczema * Infants who have not yet started consuming T9 foods (excluding cow's milk or soy if it is in their infant formula) * Parent or caregiver ≥ 18 years of age * Agree to infant blood draw (two) * Agree to participate in the 6 month research study Exclusion Criteria: * Infants with a physician confirmed food allergy * Infants who do not eat fully by an oral route such as…
Interventions
- BehavioralEducational Sessions and Opportunities on Early Introduction and Sustained Ingestion
The participant will attend three in person sessions on the basics of food allergy, food allergy reactions, feeding safety and readiness, fiber, ultra processed foods, diet diversity, and advancing food textures in the infant diet. The educational sessions will last 20 - 30 minutes every month for three months.
- BehavioralIn person feeding session
Participants will attend an in-person feeding of a known top 9 food allergen (hen's egg, cow's milk, peanut, tree nuts, soy, wheat, fin fish, shellfish, and sesame) to the infant at least one time, and up to two times. The clinic feeding will last 1 - 2 hours.
Location
- Stanford UniversityStanford, California