Clinical trial NCT05258656: Childhood Activities Nutrition and Development Oversight
Official title: Childhood Activities Nutrition and Development Oversight
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Environmental Exposure
Keywords: infant development
health promotion
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Food Allergy Research & Education
First posted: 2022-02-28
Enrollment: 1800
Sex: ALL
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 development. This study will provide information and instruction on several aspects of infant care including, sleep, nutrition, building a healthy relationship with your baby, and healthy screen time use.

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 old.

The intervention arm will receive education about nutrition, resources, and specific instructions on feeding and caring for their infants. The control arm will receive education about infant development and helpful tips about infant sleep, screen time, and building healthy relationships. In addition, all caregivers will be asked to fill out surveys and come to research visits during the study period. There will be a total of 4 study visits during the three years of the study. There will be optional blood, stool, and skin testing of the child at each study visit. Two visits will take place during the first year of life, followed by visits around the child's 2nd and 3rd birthdays.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: One year Assessment
timeFrame: ≈12 months of age
Secondary outcomes:
measure: Two year assessment
timeFrame: ≈24 months of age
measure: Three year assessment
timeFrame: ≈36 months of age
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Ruchi S Gupta, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: