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

Stanford University

Status: Not yet enrolling

Conditions: Food Allergy

Treatments: Behavioral: In person feeding session; Behavioral: Educational Sessions and Opportunities on Early Introduction and Sustained Ingestion

Study type: Interventional

Funder types: Other

Identifiers

NCT07321522

81307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 4 to 11 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 tube-fed or tube-supplemented babies
• Infants with developmental delay
• Infants with severe eczema
• Infants who are already consuming Top 9 known allergenic foods
• Infants participating in another study looking at diet, oral immunotherapy or the use of a biological agent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

The participants will be provided with three sets of educational materials to learn about early introduction of food allergens.

Enhanced Educational Opportunities

Experimental group

Description:

The participants will be provided with three sets of educational materials to learn about early introduction of food allergens, as well as 3 in-person monthly teaching sessions (up to 3 months), lasting 30 minutes to enhance the information and allow for questions. This arm will also have one to two in-clinic feedings of any of the top 9 most allergenic foods. The oral feeding portion will add an additional 1 to 2 hours at the one of the 3 visits.

Treatment:

Behavioral: Educational Sessions and Opportunities on Early Introduction and Sustained Ingestion

Behavioral: In person feeding session