Childhood Activities Nutrition and Development Oversight

NCT ID: NCT05258656

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2028-06-30

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.

Conditions

Environmental Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Maximum Eligible Age: 26 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Food Allergy Research & Education

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Ruchi Gupta

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruchi S Gupta, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Neeha Shrestha, MPH

Role: CONTACT

neeha.shrestha@northwestern.edu

312-503-4687

Facility Contacts

David Arzola

Role: primary

darzola@luriechildrens.org

312-503-4687

Donyea Moore

Role: primary

donyea_moore@rush.edu

312-942-5817

Other Identifiers

2021-4156

Identifier Type: -

Identifier Source: org_study_id