Environmental ExposureCANDONCT05258656
Childhood Activities Nutrition and Development Oversight
A study testing Intervention in people with Environmental Exposure, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 26 weeksHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2022to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 26 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Environmental Exposure
- Being tested
- Intervention, Control
- Keywords
- infant development, health promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
| 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ≈12 months of age
Secondary outcomes (2)
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.
Measured: ≈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.
Measured: ≈36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start3 Mar 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Food Allergy Research & Education
- Responsible party
- Principal investigator, Ruchi Gupta, Northwestern University
- Investigators
- Ruchi S Gupta, MD MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258656
- Sponsor's protocol ID
- 2021-4156
- Acronym
- CANDO
- Status last verified
- May 2026
- First submitted
- 11 Feb 2022
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Activities Nutrition and Development Oversight
- ClinicalTrials.gov ID
- NCT05258656
- Acronym / sponsor ID
- CANDO / 2021-4156
- Conditions
- Environmental Exposure
- Keywords
- infant development, health promotion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Food Allergy Research & Education
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe 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 comparator | Behavioral: ControlThe control group will receive specific instructions on promoting healthy development of their infant, including guidance regarding infant sleep, screen time, and building healthy relationships. |
Who may qualify
- Ages
- Up to 26 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Behavioural | Intervention |
| ControlThe control group will receive specific instructions on promoting healthy development of their infant, including guidance regarding infant sleep, screen time, and building healthy relationships. | Behavioural | Control |
Primary outcome
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.
2 secondary outcomes
Two year assessment
Time frame: ≈24 months of age
Three year assessment
Time frame: ≈36 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruchi S Gupta, MD MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Environmental Exposure, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year Assessment (time frame: ≈12 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.