Childhood Activities Nutrition and Development Oversight (CANDO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Environmental Exposure
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One year Assessment	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.	≈12 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two year assessment	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.	≈24 months of age
Three year assessment	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.	≈36 months of age

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Food Allergy Research & Education
• Investigators: Principal Investigator: Ruchi S Gupta, MD MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: health promotion; infant development
• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: 2021-4156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share deidentified, limited data sets and corresponding analytic code with other researchers following the publication of the study data. The protocol, Statistical Analysis Plan, and Informed Consent Forms will also be published online as supplemental appendices and will be made available to other researchers upon request.
• IPD Sharing Time Frame: Data and supporting information will be available indefinitely upon their publication.

IPD Sharing Access Criteria

Published study datasets will be publicly available.

Requests for unpublished data will be reviewed by the PI and advisory board and approved if deemed to have scientific merit.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No