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| Name | Class |
|---|---|
| Food Allergy Research & Education | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Control | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruchi S Gupta, MD MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Rush University Medical Center |
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.
Data and supporting information will be available indefinitely upon their publication.
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.
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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. |
|
| 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 |
| Chicago |
| Illinois |
| 60612 |
| United States |