Diet HabitNCT03313245
Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study
An observational study of Diet Habit and Cognitive Function, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
This study aims to study the relationship between diet and cognitive function among 4-5-year-olds. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Diet Habit, Cognitive Function
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 5 years
- All sexes
- Child
Study population: 4 and 5-year-olds
Who may be able to join
- Parental consent
- Child Assent
- 4 and 5 years of age
- Absence of neurological disorders
- Normal or corrected-to-normal vision
Who cannot join
- Younger than 4 and older than 5 years of age
- Presence of neurological disorders
- Uncorrected vision
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Kinesiology and Community Health
Urbana, Illinois, 61801
Naiman A Khan, PhD, RD, 217-300-2197, nakhan2@illinois.edu
Naiman A Khan, PhD, RD
About this study
This study aims to study the relationship between diet and cognitive function among 4-5-year-olds.
Read the detailed description
Children's ability for optimal cognitive function is critical for their long-term capacity to learn and achieve scholastic success. However, there is a gap in the knowledge pertaining to the selection of appropriate cognitive tasks for studying relationships between diet and cognitive control, particularly among young children. Accordingly, this study aims to study the relationship between diet and cognitive function using a standardized neuropsychological assessment and a modified cognitive task battery.
- Conditions
- Diet Habit, Cognitive Function
- Being tested
- No Intervention/Observational Study
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention/Observational StudyOther
No Intervention/Observational Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Cognitive and Academic Development
Woodcock Johnson IV eCAD
Measured: Once at laboratory visit
Secondary outcomes (3)
Attention
2-stimulus Oddball task
Measured: Once at laboratory visit
Cognitive Flexibility
Hearts and Flowers Task
Measured: Once at laboratory visit
Diet Quality
Healthy Eating Index
Measured: 7-day average following first laboratory visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Aug 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Principal investigator, Naiman Khan, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313245
- Sponsor's protocol ID
- 16484
- Status last verified
- Oct 2018
- First submitted
- 13 Oct 2017
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study
- ClinicalTrials.gov ID
- NCT03313245
- Acronym / sponsor ID
- 16484
- Conditions
- Diet Habit, Cognitive Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 18 Oct 2017 (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.
This study aims to study the relationship between diet and cognitive function among 4-5-year-olds.
Detailed description
Children's ability for optimal cognitive function is critical for their long-term capacity to learn and achieve scholastic success. However, there is a gap in the knowledge pertaining to the selection of appropriate cognitive tasks for studying relationships between diet and cognitive control, particularly among young children. Accordingly, this study aims to study the relationship between diet and cognitive function using a standardized neuropsychological assessment and a modified cognitive task battery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- 4 and 5-year-olds
Key inclusion criteria (5 listed)
- Parental consent
- Child Assent
- 4 and 5 years of age
- Absence of neurological disorders
- Normal or corrected-to-normal vision
Key exclusion criteria (3 listed)
- Younger than 4 and older than 5 years of age
- Presence of neurological disorders
- Uncorrected vision
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 |
|---|---|---|
| No Intervention/Observational StudyNo Intervention/Observational Study | Other | – |
Primary outcome
Early Cognitive and Academic Development
Time frame: Once at laboratory visit
Woodcock Johnson IV eCAD
3 secondary outcomes
Attention
Time frame: Once at laboratory visit
Cognitive Flexibility
Time frame: Once at laboratory visit
Diet Quality
Time frame: 7-day average following first laboratory visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit and Cognitive Function, run by University of Illinois at Urbana-Champaign at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naiman A Khan, PhD, RD (2173002197, nakhan2@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Cognitive and Academic Development (time frame: Once at laboratory visit). 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 10 Oct 2018; AzTrials last refreshed its copy on 3 Nov 2026.