Nutrition and Cognitive Function in Preadolescents | NCT02636998

Studies
Nutrition and Cognitive Function in Preadolescents

NCT02636998

Sponsor

Arkansas Children's Hospital Research Institute

Status

Active, not recruiting

Last Update Posted

Jan 29, 2025Actual

Enrollment

116Estimated

Phase

Not provided

Conditions

Healthy Children

Interventions

Not provided

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Jan 6, 2024Actual

Completion Date

Dec 2025Estimated

First Submitted Date

Jun 22, 2015

First Submission Date that Met QC Criteria

Dec 18, 2015

First Posted Date

Dec 22, 2015Estimated

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

Jan 27, 2025

Last Update Posted Date

Jan 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 is designed to evaluate cognitive function in preadolescents who have different body mass indexes.

Detailed Description

The investigators plan to document differences between normal weight and obese preadolescents on psychological and neurocognitive measures of executive function controlling for factors known to influence brain function and behavior not considered in previous studies.

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

Retention

Enrollment

116Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal weight		BMI <85th percentile
Obese		BMI > 95th percentile

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychological assessments	Standardized assessments	9-10 years
Neurocognitive measures	Brain Lab Recordings	9-10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal weight (BMI: <85th percentile) or obese (BMI: >95th percentile)
Right hand dominance
Report eating breakfast at least 4 days/week
Able to hear at least 20 dB stimulus
Visual acuity must be at least 20/40
Arithmetic Computation Task
Biological mother available to attend the enrollment study visit

Exclusion Criteria:

Full Scale IQ <80
Children taking medications or having chronic illnesses/disorders that may independently affect study outcome measures (as determined by the PI)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Preadolescents and their mothers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linda Larson-Prior, Ph.D	Arkansas Children's Nutrition Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States