Diet Quality and Cognitive Control Function in Early Chil... | NCT03313245

Studies
Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study

NCT03313245

Sponsor

University of Illinois at Urbana-Champaign

Status

Unknown status

Last Update Posted

Oct 10, 2018Actual

Enrollment

104Estimated

Phase

Not provided

Conditions

Diet Habit
Cognitive Function

Interventions

No Intervention/Observational Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Oct 13, 2017

First Submission Date that Met QC Criteria

Oct 13, 2017

First Posted Date

Oct 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 10, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Naiman Khan, Assistant Professor, University of Illinois at Urbana-ChampaignPrincipal Investigator

Lead Sponsor

University of Illinois at Urbana-ChampaignOTHER

Collaborators

Name	Class
National Dairy Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention/Observational Study	Other	No Intervention/Observational Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early Cognitive and Academic Development	Woodcock Johnson IV eCAD	Once at laboratory visit

Secondary Outcomes

Measure	Description	Time Frame
Attention	2-stimulus Oddball task	Once at laboratory visit
Cognitive Flexibility	Hearts and Flowers Task	Once at laboratory visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parental consent
Child Assent
4 and 5 years of age
Absence of neurological disorders
Normal or corrected-to-normal vision

Exclusion Criteria:

Younger than 4 and older than 5 years of age
Presence of neurological disorders
Uncorrected vision

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

4 and 5-year-olds

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Naiman A Khan, PhD, RD	Contact	2173002197		nakhan2@illinois.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Kinesiology and Community Health	Recruiting	Urbana	Illinois	61801	United States

Condition Browse Module

MeSH Terms

ID	Term
D005247	Feeding Behavior

Ancestor Terms

ID	Term
D001522	Behavior, Animal
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided