Childhood Body Composition and Brain Structure and Function

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72203
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obese
Normal weight

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiawei Ou, PhD, Arkansas Children's Nutrition Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (Estimated)

April 2, 2013

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 133540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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