Childhood Activities Nutrition and Development Oversight

Not Applicable

Recruiting

• Conditions: Environmental Exposure
• Interventions: Behavioral: Control; Behavioral: Intervention

• Registration Number: NCT05258656
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-02-28
• Study Start: 2022-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control group will receive specific instructions on promoting healthy development of their infant, including guidance regarding infant sleep, screen time, and building healthy relationships.
Intervention	Intervention	The intervention group will receive education about nutrition, resources, and specific instructions on promoting healthy development of their infant, including guidance regarding infant sleep, screen time, and building healthy relationships.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Two year assessment	≈24 months of age	Caregivers and their child will be asked to attend a research study visit with a physician around the child's 2nd 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.
Three year assessment	≈36 months of age	Caregivers and their child will be asked to attend a research study visit with a physician around the child's 3rd 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.

Trial Locations

Locations (2)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States