HealthyNCT03499587
Effects of Maternal Obesity on Offspring Brain Development
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2018to 27 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant healthy volunteers
Who may be able to join
- BMI 18.5-25 or >30 with early OB visit medical records accessible
- singleton pregnancy
- about 36wks of pregnancy
- at least 18 years of age
Who cannot join
- hypertension, diabetes, or other preexisting medical conditions
- medications known to influence fetal growth
- recreational drugs, nicotine or tobacco use of alcohol use while pregnant
- pregnancy conception with assisted fertility treatment
- medical complications developed during pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.
Read the detailed description
This study will recruit pregnant women who are either obese or normal weight and otherwise healthy. We will measure their body composition, food intake and other characteristics during pregnancy. When their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. We will then compare the findings and see if their are differences.
- 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 |
|---|---|---|
| Obese pregnant women | BMI >30 with early OB visit medical records accessible | |
| Normal weight pregnant women | BMI 18.5-25 with early OB visit medical records accessible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether maternal obesity correlates with abnormal brain development in newborns
Brain will be imaged at 2wks using an MRI
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start21 Mar 2018
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Dec 2026 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499587
- Sponsor's protocol ID
- 206551
- Status last verified
- Oct 2025
- First submitted
- 9 Apr 2018
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Obesity on Offspring Brain Development
- ClinicalTrials.gov ID
- NCT03499587
- Acronym / sponsor ID
- 206551
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Dec 2026 (estimated)
- First posted
- 17 Apr 2018 (actual)
- 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 goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.
Detailed description
This study will recruit pregnant women who are either obese or normal weight and otherwise healthy. We will measure their body composition, food intake and other characteristics during pregnancy. When their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. We will then compare the findings and see if their are differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese pregnant women | – | –BMI >30 with early OB visit medical records accessible |
| Normal weight pregnant women | – | –BMI 18.5-25 with early OB visit medical records accessible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant healthy volunteers
Key inclusion criteria (4 listed)
- BMI 18.5-25 or >30 with early OB visit medical records accessible
- singleton pregnancy
- about 36wks of pregnancy
- at least 18 years of age
Key exclusion criteria (5 listed)
- hypertension, diabetes, or other preexisting medical conditions
- medications known to influence fetal growth
- recreational drugs, nicotine or tobacco use of alcohol use while pregnant
- pregnancy conception with assisted fertility treatment
- medical complications developed during pregnancy
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
Determine whether maternal obesity correlates with abnormal brain development in newborns
Time frame: 2 weeks
Brain will be imaged at 2wks using an MRI
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 5 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?
Determine whether maternal obesity correlates with abnormal brain development in newborns (time frame: 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.