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NCT05258656

Childhood Activities Nutrition and Development Oversight

Active, Not Recruiting
NAUp to 26InterventionalPrevention
Northwestern University
~1,800 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:InterventionControl

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
One year Assessment
Measured over ≈12 months of age

Conditions

Environmental Exposure

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Infant Development

NCT05258656

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinoisno site contact published

  • Rush University Medical Center

    Chicago, Illinoisno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ruchi S Gupta, MD MPH · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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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

What this trial measures

  • One year Assessment≈12 months of age

    Caregivers and their child will be asked to attend a research study visit with a physician around the child's 1st birthday that may involve brief examination of the child's skin, surveys about the child's medical history and diet, a supervised feeding of certain common foods, and/or collection of a blood sample.