NCT01822054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

February 26, 2013

Last Update Submit

December 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Brain Function

    8-10 years of age

Study Arms (2)

Normal weight

Obese

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72203, United States

Location

Study Officials

  • Xiawei Ou, PhD

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

April 2, 2013

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2014

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

US(1)