Childhood Body Composition and Brain Structure and Function | NCT01822054

Studies
Childhood Body Composition and Brain Structure and Function

NCT01822054

Sponsor

Arkansas Children's Hospital Research Institute

Status

Completed

Last Update Posted

Dec 20, 2023Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Healthy

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2014Actual

First Submitted Date

Feb 26, 2013

First Submission Date that Met QC Criteria

Apr 1, 2013

First Posted Date

Apr 2, 2013Estimated

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

Dec 18, 2023

Last Update Posted Date

Dec 20, 2023Actual

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

The specific aim of this research project is to use MRI methods to evaluate and compare brain structure and function in normal weight and obese children age 8-10 years.

Detailed Description

Not provided

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

27Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain structure	We will use high resolution volumetric MRI and DTIto measure the brain structure of these children	8 - 10 years of age

Secondary Outcomes

Measure	Description	Time Frame
Brain Function	We will use high resolution fMRI to measure the brain function under different cognitive paradigms	8-10 years of age

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy normal weight or obese children
Parental report of full-term gestation
Parental report of birth weight between 5th-95th percentiles
Parental report of breastfeeding or cow's milk formula fed during infancy
Right hand dominance

Exclusion Criteria:

Maternal diabetes
Maternal alcohol, tobacco or drug use during pregnancy
Chronic sleep disorder
History of psychological or psychiatric diagnosis
History of neurological impairment or injury
Surgical implant or other foreign object in the body which may be a MRI safety concern
Dental work which may cause artifacts in MRI
Claustrophobia
High likelihood of inability to tolerate loud noise from the MRI scanner

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Healthy normal weight or obese children (age 8-10 years)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiawei Ou, PhD	Arkansas Children's Nutrition Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72203	United States

Label	Type	Description	Intervention Names
Normal weight
Obese