ObesityFEMANCT00715754
Antecedents of Obesity: Fetal Measures of Adiposity
An observational study of Obesity, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound can predict infant adiposity by air displacement plethysmography at birth. Read more about this study
- Who is it for?
- Ages 24 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born at the University of Utah Hospital, whose mothers received prenatal care also at the University of Utah Hospital.
Who may be able to join
- Infants of mothers between the ages of 18 and 45, planning child birth at the University of Utah Hospital, and willing to provide parental permission for the child to participate in the study.
Who cannot join
- Infants of mothers under the age of 18, over the age of 45, planning child birth at another facility other than the University of Utah Hospital, or who are not willing to provide permission for the child to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antecedents of Obesity: Fetal Measures of Adiposity, "A Plan for Obesity Disaster Management"
The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound can predict infant adiposity by air displacement plethysmography at birth.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Adiposity at 24-72 Hours Following Birth
Adiposity as measured by air displacement plethysmography
Measured: 24-72 hours following birth
Fetal Abdominal Circumference
Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.
Measured: 35 weeks gestation
Estimated Fetal Weight Percentile
Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.
Measured: 35 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Moyer-Mileur, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715754
- Sponsor's protocol ID
- 18858
- Acronym
- FEMA
- Status last verified
- Dec 2017
- First submitted
- 10 Jul 2008
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antecedents of Obesity: Fetal Measures of Adiposity, "A Plan for Obesity Disaster Management"
- ClinicalTrials.gov ID
- NCT00715754
- Acronym / sponsor ID
- FEMA / 18858
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound can predict infant adiposity by air displacement plethysmography at birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born at the University of Utah Hospital, whose mothers received prenatal care also at the University of Utah Hospital.
Key inclusion criteria (1 listed)
- Infants of mothers between the ages of 18 and 45, planning child birth at the University of Utah Hospital, and willing to provide parental permission for the child to participate in the study.
Key exclusion criteria (1 listed)
- Infants of mothers under the age of 18, over the age of 45, planning child birth at another facility other than the University of Utah Hospital, or who are not willing to provide permission for the child to participate in the study.
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
Infant Adiposity at 24-72 Hours Following Birth
Time frame: 24-72 hours following birth
Adiposity as measured by air displacement plethysmography
Fetal Abdominal Circumference
Time frame: 35 weeks gestation
Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.
Estimated Fetal Weight Percentile
Time frame: 35 weeks gestation
Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Laurie Moyer-Mileur, PhD principal investigator
University of Utah
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 Obesity, run by University of Utah 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: finished, as of the sponsor's last update on 23 Jan 2018. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Infant Adiposity at 24-72 Hours Following Birth (time frame: 24-72 hours following birth). The study lists 3 primary outcomes in all. 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 23 Jan 2018.