Childhood Activities Nutrition and Development Oversight (CANDO)

Northwestern University

Status: Enrolling

Conditions: Environmental Exposure

Treatments: Behavioral: Intervention; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05258656

2021-4156

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,800 estimated patients

Sex: All

Ages: Under 26 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,800 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention

Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Control