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NCT Number: NCT05258656

Childhood Activities Nutrition and Development Oversight

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Environmental Exposure

Age range

Up to 26 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

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

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.

Primary outcomes

  1. One year Assessment

    Time frame: ≈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 outcomes

  1. Two year assessment

    Time frame: ≈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.

  2. Three year assessment

    Time frame: ≈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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Food Allergy Research & Education

Registry information

Acronym: CANDO

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Feb 28, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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