HealthyNCT01822054
Childhood Body Composition and Brain Structure and Function
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy normal weight or obese children (age 8-10 years)
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Dental work which may cause artifacts in MRI
- Claustrophobia
- High likelihood of inability to tolerate loud noise from the MRI scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72203
About this study
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.
- Conditions
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Not described | |
| Obese | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain structure
We will use high resolution volumetric MRI and DTIto measure the brain structure of these children
Measured: 8 - 10 years of age
Secondary outcomes (1)
Brain Function
We will use high resolution fMRI to measure the brain function under different cognitive paradigms
Measured: 8-10 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiawei Ou, PhD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822054
- Sponsor's protocol ID
- 133540
- Status last verified
- Dec 2023
- First submitted
- 26 Feb 2013
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Body Composition and Brain Structure and Function
- ClinicalTrials.gov ID
- NCT01822054
- Acronym / sponsor ID
- 133540
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | – |
| Obese | – | – |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy normal weight or obese children (age 8-10 years)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Brain Function
Time frame: 8-10 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiawei Ou, PhD principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structure (time frame: 8 - 10 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.