NCT07321522

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

Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 4 Months – 11 Months
• Healthy volunteers: Accepted

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.

Detailed 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 additionally have in-person or live-stream video opportunities instructing further about the same materials and ask questions of the research team. The intervention group will additionally have one and up to two opportunities to feed their infant in the clinical research unit one of the top 9 known US allergenic foods (Top 9) with the feeding staffed with emergency response personnel and supportive clinical care. Both groups will complete the same quiz following each educational set of materials to evaluate the helpfulness and understanding of each. Both groups will record the intake of the Top 9 for the first 3 months. Both groups will record the intake of the Top 9, fruit/vegetable, whole grains, legumes, seeds and ultra processed food intake for the second 3 months of the study. Both groups will undergo a blood draw on the infant at the first and last visits. Both groups will complete a pre and post study questionnaire. The standard-of-care group will be offered the opportunity to return to the clinic to feed a Top 9 food when their enrollment is fully completed.

Conditions

• Food Allergy

Interventions

Type	Name	Description
BEHAVIORAL	Educational 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.
BEHAVIORAL	In 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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States