NCT05258656

Childhood Activities Nutrition and Development Oversight

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 26 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Environmental Exposure

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2022-03-03
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2022-02-28
• Last updated: 2025-04-27

Locations

2 sites across 1 country: United States