- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01822054
Childhood Body Composition and Brain Structure and Function
December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
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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