Brain FunctionNCT01822067
Effects of Maternal Body Composition on Offspring Brain Structure and Function
An observational study of Brain Function, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The specific aim of this study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers. Read more about this study
- Who is it for?
- Ages 11 to 17 daysHealthy volunteers can take part
- Conditions the study is for
- Brain Function
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 11 to 17 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full term neonates born from obese or lean mothers enrolled in the Glowing study (IRB#110889)
Who may be able to join
- the participant must be enrolled in the Arkansas Children's Nutrition Center (ACNC) Glowing study and be about 2 weeks of age +/- 3days
Who cannot join
- none specified
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 study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers.
- Conditions
- Brain Function
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- Non Maternal obesity | Full-term neonates at 2 weeks of age born to normal weight mothers | |
| Obese- Obese Mothers | Full-term neonates at two weeks of age born of obese mothers |
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 magnetic resonance imaging (MRI) and Diffusion tensor imaging (DTI) to measure the brain structure of 2 week old infants
Measured: Age 2 weeks
Secondary outcomes (1)
Brain Function
We will use high resolution Resting state functional magnetic resonance imaging (rsfMRI) to measure the brain function of 2 week old infants
Measured: Age 2 weeks
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 startAug 2012
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain FunctionStudies 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
- 100 participants (estimated)
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
- NCT01822067
- Sponsor's protocol ID
- 134776
- Status last verified
- Oct 2025
- First submitted
- 26 Feb 2013
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maternal Body Composition on Offspring Brain Structure and Function
- ClinicalTrials.gov ID
- NCT01822067
- Acronym / sponsor ID
- 134776
- Conditions
- Brain Function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- 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 study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight- Non Maternal obesity | – | –Full-term neonates at 2 weeks of age born to normal weight mothers |
| Obese- Obese Mothers | – | –Full-term neonates at two weeks of age born of obese mothers |
Who may qualify
- Ages
- 11 to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full term neonates born from obese or lean mothers enrolled in the Glowing study (IRB#110889)
Key inclusion criteria (1 listed)
- the participant must be enrolled in the Arkansas Children's Nutrition Center (ACNC) Glowing study and be about 2 weeks of age +/- 3days
Key exclusion criteria (1 listed)
- none specified
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: Age 2 weeks
We will use high resolution volumetric magnetic resonance imaging (MRI) and Diffusion tensor imaging (DTI) to measure the brain structure of 2 week old infants
1 secondary outcome
Brain Function
Time frame: Age 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Related trials for Brain Function
RecruitingObservational study
Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia
CAR T-cell Therapy, Autoimmune Hemolytic Anemia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2
AKG and Brain Health in Aging
Brain Aging, Cerebrovascular Function
RecruitingPhase 2
UCSD Image-Guided Cognitive-Sparing Radiosurgery for Intracranial Lesions
Brain Metastases, Adult, Neurocognitive Function
Recruiting
Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
Brain Function, Hemiarch Cardiac Procedure
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 Brain Function, 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: Age 2 weeks). 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 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.