Childhood Activities Nutrition and Development Oversight
CANDO
1 other identifier
interventional
1,800
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedStudy Start
First participant enrolled
March 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 27, 2025
April 1, 2025
4.2 years
February 11, 2022
April 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Two year assessment
≈24 months of age
Three year assessment
≈36 months of age
Study Arms (2)
Intervention
EXPERIMENTALThe 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
PLACEBO COMPARATORThe 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Infant with a sibling enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- Food Allergy Research & Educationcollaborator
Study Sites (2)
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruchi S Gupta, MD MPH
Northwestern University Feinberg School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 11, 2022
First Posted
February 28, 2022
Study Start
March 3, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2028
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data and supporting information will be available indefinitely upon their publication.
- 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.
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.