Promoting healthy development in infants through caregiver education
Childhood Activities Nutrition and Development Oversight
This study is testing if giving parents specific education about nutrition and infant care can help their babies develop healthier during the first three years of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | N/A to 26 Weeks |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05258656 on ClinicalTrials.gov |
What this trial studies
This study aims to understand how common childhood conditions develop and whether providing specific health education and resources to parents can promote healthy infant development. It is a randomized controlled trial involving parents and infants in the Greater Chicago area, following them until the children are three years old. The intervention group will receive targeted education on nutrition and infant care, while the control group will receive general information about infant development. Participants will complete surveys and attend four study visits over three years, with optional testing at each visit.
Who should consider this trial
Good fit: Ideal candidates include parents or guardians of infants under 26 weeks of age who are willing to participate in the study and comply with its procedures.
Not a fit: Patients with infants who have significant medical conditions or dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes and developmental milestones for infants through enhanced caregiver education.
How similar studies have performed: Other studies have shown success in similar educational interventions aimed at promoting infant health and development.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Ruchi S Gupta, MD MPH — Northwestern University Feinberg School of Medicine
- Study coordinator: Neeha Shrestha, MPH
- Email: neeha.shrestha@northwestern.edu
- Phone: 312-503-4687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.