RecruitingNot ApplicableNCT05258656

Childhood Activities Nutrition and Development Oversight


Sponsor

Northwestern University

Enrollment

1,800 participants

Start Date

Mar 3, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 26 Weeks

Inclusion Criteria6

  • 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 Criteria8

  • 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

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Interventions

BEHAVIORALIntervention

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.

BEHAVIORALControl

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.


Locations(2)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

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NCT05258656


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