ObesityMBCNCT02586714
Maternal Body Composition Regulates Placental Function
An observational study of Obesity and Pregnancy, run by National Center for Research Resources (NCRR).
Trial summary
This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2013
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women at term with singleton gestation who were normal weight, overweight, or obese.
Who may be able to join
- Healthy pregnant women at term with singleton gestation
Who cannot join
- Medical condition requiring daily medication Fetal congenital anomalies Diabetes
About this study
This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy.
Read the detailed description
This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy. This project integrates body composition analysis, nutrition, and metabolic factors to study the impact of maternal body composition and diet on placental function and fetal growth.
Research Project: The proposed enrollment of 41 pregnant women at term (>37 weeks gestation) was completed in September 2013. The subjects underwent four body composition measurements (bioelectrical impedance, skin-fold thickness, BodPod, and deuterium dilution) and dietary surveys along with a fasting blood draw. The subjects returned 2 weeks postpartum for repeat measurements along with a DEXA scan.
- Being tested
- No intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observation only
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Not described Receives: Other: No intervention | |
| Overweight | Not described Receives: Other: No intervention | |
| Obese | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare maternal body fat measurement
Subjects presented for their study visits in the morning following an overnight fast. During the first visit, at 37-38 weeks' gestation, they underwent four measures: 1) ADP, 2) TBW volume by deuterium (2H2O) dilution, 3) skin-fold thickness (SFT), and 4) bioelectrical impedance analysis (BIA). To determine maternal FM (kg) without the presence of the fetus or placenta, and to avoid radiation exposure to the fetus, subjects returned for a second study visit two weeks postpartum for repeat measurements by the above methods plus a dual-energy x-ray absorptiometry scan (DXA) scan. Statistical analysis was performed using the R package Method Comparison Regression, version 1.2.1. Estimates of mean FM (kg) were compared by analysis of variance.
Measured: 37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startJul 2012
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Nicole Marshall, National Center for Research Resources (NCRR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586714
- Sponsor's protocol ID
- 2KL2RR024141-06
- Acronym
- MBC
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2015
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Marshall NE, Murphy EJ, King JC, Haas EK, Lim JY, Wiedrick J, Thornburg KL, Purnell JQ. Comparison of multiple methods to measure maternal fat mass in late gestation. Am J Clin Nutr. 2016 Apr;103(4):1055-63. doi: 10.3945/ajcn.115.113464. Epub 2016 Feb 17.
PubMed 26888714
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Body Composition Regulates Placental Function
- ClinicalTrials.gov ID
- NCT02586714
- Acronym / sponsor ID
- MBC / 2KL2RR024141-06
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Oregon Health and Science University
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Oct 2015 (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.
This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy.
Detailed description
This study examined the relationships between maternal body composition, placental function, and fetal nutrition and body composition, and sought to determine the most accurate method of maternal body composition analysis in late pregnancy. This project integrates body composition analysis, nutrition, and metabolic factors to study the impact of maternal body composition and diet on placental function and fetal growth.
Research Project: The proposed enrollment of 41 pregnant women at term (>37 weeks gestation) was completed in September 2013. The subjects underwent four body composition measurements (bioelectrical impedance, skin-fold thickness, BodPod, and deuterium dilution) and dietary surveys along with a fasting blood draw. The subjects returned 2 weeks postpartum for repeat measurements along with a DEXA scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | Other: No intervention |
| Overweight | – | Other: No intervention |
| Obese | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women at term with singleton gestation who were normal weight, overweight, or obese.
Key inclusion criteria (1 listed)
- Healthy pregnant women at term with singleton gestation
Key exclusion criteria (1 listed)
- Medical condition requiring daily medication Fetal congenital anomalies Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservation only | Other | Normal weight, Obese, Overweight |
Primary outcome
Compare maternal body fat measurement
Time frame: 37 weeks gestation
Subjects presented for their study visits in the morning following an overnight fast. During the first visit, at 37-38 weeks' gestation, they underwent four measures: 1) ADP, 2) TBW volume by deuterium (2H2O) dilution, 3) skin-fold thickness (SFT), and 4) bioelectrical impedance analysis (BIA). To determine maternal FM (kg) without the presence of the fetus or placenta, and to avoid radiation exposure to the fetus, subjects returned for a second study visit two weeks postpartum for repeat measurements by the above methods plus a dual-energy x-ray absorptiometry scan (DXA) scan. Statistical analysis was performed using the R package Method Comparison Regression, version 1.2.1. Estimates of mean FM (kg) were compared by analysis of variance.
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 8 Jul 2025.
- Derived from this study: PubMed 26888714Marshall NE, Murphy EJ, King JC, Haas EK, Lim JY, Wiedrick J, Thornburg KL, Purnell JQ. Comparison of multiple methods to measure maternal fat mass in late gestation. Am J Clin Nutr. 2016 Apr;103(4):1055-63. doi: 10.3945/ajcn.115.113464. Epub 2016 Feb 17.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Pregnancy, run by National Center for Research Resources (NCRR).
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: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare maternal body fat measurement (time frame: 37 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586714, which also lists 1 linked publication.
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 8 Jul 2025.