Status:
RECRUITING
Childhood Activities Nutrition and Development Oversight
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Food Allergy Research & Education
Conditions:
Environmental Exposure
Eligibility:
All Genders
Up to 26 years
Phase:
NA
Brief Summary
The overall goal of this study is to understand how common conditions in childhood develop and if by providing specific health education and resources to parents/caregivers we can promote healthy deve...
Detailed Description
This study is a randomized controlled trial that will recruit parents/caregivers and infants infants living in the Greater Chicago area . The study will follow these infants until they are three years...
Eligibility Criteria
Inclusion
- Parent/guardian(s) must understand and provide informed consent
- Infant \<26 weeks of age at enrollment
- Willing to be randomized to either intervention or control
- In good general health as evidenced by medical history
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Child assigned male or female sex at birth
Exclusion
- Infant completed less than 28 weeks gestation
- Co-morbid medical diagnoses that would prevent caregivers from initiating solid foods per protocol, such as dysphagia, chronic aspiration, malformations, etc.
- Co-morbid medical diagnoses that would require specialized diet/nutritional needs, such as congenital heart disease, genetic/metabolic disorders, malignancy, etc.
- Caregivers who express unwillingness to introduce peanut, milk, egg, or cashew
- Caregivers who cannot provide informed consent in English or Spanish
- Parents planning to move away from study sites before child is 12 months of age
- Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study
- Infant with a sibling enrolled in the study
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT05258656
Start Date
March 3 2022
End Date
June 1 2028
Last Update
April 27 2025
Active Locations (2)
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1
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Rush University Medical Center
Chicago, Illinois, United States, 60612