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 feasibility pilot study will randomly assign caretaker/child dyads into two groups stratified by age; 50% will be assigned to the intervention group, the other 50% to the standard-of-care group (SOC). Using the foods of each families home and culture, participants in the standard-of-care group will be instructed through 3 educational packets in early introduction and infant nutrition metered one month apart. The content includes scientifically supported written, audio and video materials that are widely available to the general public. The SOC group has the option to come to the c…
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 known allergenic 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…
Interventions
- BehavioralEducation and Opportunities on Early Introduction
The participant will receive and review three educational modules on the basics of food allergy, food allergy reactions, food allergen introduction, feeding safety and readiness, fiber, fermented food, ultra processed foods, diet diversity, and advancing food textures in the infant diet. The educational sessions will take approximately one hour to review every month for three months.
- BehavioralClinician Supervised Feeding of Known Allergenic Food
Clinician supervised feeding introduction of a known allergenic food (hen's egg, cow's milk, peanut, tree nuts, soy, wheat, fin fish, shellfish, and sesame) to the infant at least one time during the 6 month enrollment. The feeding is required for the intervention group and optional for the standard-of-care (SOC) group. Participants in the SOC group who do not introduce any known allergenic foods at home into the infant's diet by the end of 3 months enrollment will be required to return to the clinic for a clinician supervised feeding of a known allergenic food of their choice. The clinic feeding will last approximately 1 hour.
Location
- Stanford UniversityStanford, California