ObesityNCT00634764
Predictors of Maternal Weight Gain and Neonatal Body Composition
An observational study of Obesity, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Obesity is a significant health issue in the United States with 30% of the US population considered obese defined as a body mass index above 30 kg/m2. Obesity is associated with long term health complications including diabetes and cardiovascular disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jul 2008
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of pregnant women who present for prenatal care at MUSC's Cannon Place clinic or Prenatal Wellness Center prior to 16 weeks gestational age.
Who may be able to join
- Women must be obtaining prenatal care at Cannon Place clinic or at the Prenatal Wellness Center
- Enrolled for prenatal care at less than 16 weeks gestational age
- Singleton pregnancy without fetal abnormalities
- Ability to provide informed consent
- Subjects must complete prenatal visits when data will be collected, and be willing and able to attend three GCRC study visits
- Maternal age >18 and <45
- Neonate born to mother enrolled in trial
Who cannot join
- Subjects with diabetes, hypertension, prior preterm birth, chronic respiratory disease (asthma on daily medication, COPD, cystic fibrosis) or maternal cardiac disease
- Subjects currently taking insulin sensitizing medications (metformin)
- Subject unable to perform MedGem procedure
- Neonates delivered prior to 34 weeks gestational age will be excluded from analysis by the DEXA scan
- Neonates with fetal anomalies diagnoses in the antenatal period or postpartum will not be included in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Resting Metabolic Rate, Insulin Resistance, and Attitude Towards Weight Gain During Pregnancy to Predict Maternal Weight Gain and Neonatal Body Composition.
Obesity is a significant health issue in the United States with 30% of the US population considered obese defined as a body mass index above 30 kg/m2. Obesity is associated with long term health complications including diabetes and cardiovascular disorders. During pregnancy, obesity is associated with an increased risk of fetal macrosomia and birth injury, as well as increased risk of gestational diabetes, preeclampsia, cesarean birth, and preterm birth. The intrauterine environment has been purported to influence the early childhood and lifelong risk of obesity and the metabolic syndrome (obesity, hyperlipidemia, and insulin resistance [IR]). The Institute of Medicine guidelines for maternal weight gain in pregnancy provide an estimate for population goals, but may be inadequate for individual patient needs. Other factors, such as the degree of maternal IR and resting metabolic rate (RMR) may be more predictive of actual nutritional needs during pregnancy. A better determination of caloric and exercise needs may allow the development of more specific dietary recommendations during pregnancy. Optimal nutrition will result in improved maternal and neonatal outcomes. As the intrauterine environment may have important impacts on neonatal and childhood metabolic and cardiovascular outcomes, creation of a favorable intrauterine environment through optimal maternal nutritional and exercise guidelines may reduce well documented problems such as fetal macrosomia, birth injury, cesarean delivery, and later predisposition toward childhood obesity.
The goal of this pilot trial therefore is to correlate maternal resting metabolic rate, dietary characteristics, and insulin resistance levels with fetal birth weight and body composition in an effort to determine which factors are associated with excessive fat mass in the neonate, placing them at increased lifetime risk of obesity.
We hypothesize that women with lower resting metabolic rates (RMR) in the first trimester will demonstrate a greater maternal weight gain, when adjusted for caloric intake and activity. It is also hypothesized that for a given RMR, the degree of maternal insulin resistance (IR) predicts birthweight adjusted for a given caloric intake. A third hypothesis is that women with increased insulin resistance (measured by HOMA) will result in neonates with larger birth weights and a greater degree of neonatal fat mass as measure by DEXA scan, adjusted for RMR and diet characteristics.
- Conditions
- Obesity
- Keywords
- Maternal weight gain, Neonatal birth weight, Weight gain attitude, Pregnancy, Body fat, Maternal Behavior, Birth outcomes
- Medical subject headings
- Obesity, Gestational Weight Gain
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 |
|---|---|---|
| Pregnant | Pregnant women who present to MUSC's Cannon Place or Prenatal Wellness Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight gain, resting metabolic rate (kcal/day)
Measured: During gestation
Neonatal birth weight (gram), ponderal index
Measured: After birth
Secondary outcomes (1)
Maternal diet composition, exercise evaluation, insulin resistance, weight gain attitude
Measured: During gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startNov 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- William Goodnight, MD, Principal investigator, Medical University of South CarolinaDonna Johnson, Study chair, Medical University of South Carolina, Obstetrics-Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634764
- Sponsor's protocol ID
- HR # 16751
- Other IDs
- GCR Protocol # 769
- Status last verified
- May 2018
- First submitted
- 19 Feb 2008
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Metabolic Rate, Insulin Resistance, and Attitude Towards Weight Gain During Pregnancy to Predict Maternal Weight Gain and Neonatal Body Composition.
- ClinicalTrials.gov ID
- NCT00634764
- Acronym / sponsor ID
- HR # 16751
- Conditions
- Obesity
- Keywords
- Maternal weight gain, Neonatal birth weight, Weight gain attitude, Pregnancy, Body fat, Maternal Behavior, Birth outcomes
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Nov 2006 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Mar 2008 (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.
Obesity is a significant health issue in the United States with 30% of the US population considered obese defined as a body mass index above 30 kg/m2. Obesity is associated with long term health complications including diabetes and cardiovascular disorders. During pregnancy, obesity is associated with an increased risk of fetal macrosomia and birth injury, as well as increased risk of gestational diabetes, preeclampsia, cesarean birth, and preterm birth. The intrauterine environment has been purported to influence the early childhood and lifelong risk of obesity and the metabolic syndrome (obesity, hyperlipidemia, and insulin resistance [IR]). The Institute of Medicine guidelines for maternal weight gain in pregnancy provide an estimate for population goals, but may be inadequate for individual patient needs. Other factors, such as the degree of maternal IR and resting metabolic rate (RMR) may be more predictive of actual nutritional needs during pregnancy. A better determination of caloric and exercise needs may allow the development of more specific dietary recommendations during pregnancy. Optimal nutrition will result in improved maternal and neonatal outcomes. As the intrauterine environment may have important impacts on neonatal and childhood metabolic and cardiovascular outcomes, creation of a favorable intrauterine environment through optimal maternal nutritional and exercise guidelines may reduce well documented problems such as fetal macrosomia, birth injury, cesarean delivery, and later predisposition toward childhood obesity.
The goal of this pilot trial therefore is to correlate maternal resting metabolic rate, dietary characteristics, and insulin resistance levels with fetal birth weight and body composition in an effort to determine which factors are associated with excessive fat mass in the neonate, placing them at increased lifetime risk of obesity.
We hypothesize that women with lower resting metabolic rates (RMR) in the first trimester will demonstrate a greater maternal weight gain, when adjusted for caloric intake and activity. It is also hypothesized that for a given RMR, the degree of maternal insulin resistance (IR) predicts birthweight adjusted for a given caloric intake. A third hypothesis is that women with increased insulin resistance (measured by HOMA) will result in neonates with larger birth weights and a greater degree of neonatal fat mass as measure by DEXA scan, adjusted for RMR and diet characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant | – | –Pregnant women who present to MUSC's Cannon Place or Prenatal Wellness Center |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of pregnant women who present for prenatal care at MUSC's Cannon Place clinic or Prenatal Wellness Center prior to 16 weeks gestational age.
Key inclusion criteria (7 listed)
- Women must be obtaining prenatal care at Cannon Place clinic or at the Prenatal Wellness Center
- Enrolled for prenatal care at less than 16 weeks gestational age
- Singleton pregnancy without fetal abnormalities
- Ability to provide informed consent
- Subjects must complete prenatal visits when data will be collected, and be willing and able to attend three GCRC study visits
Key exclusion criteria (5 listed)
- Subjects with diabetes, hypertension, prior preterm birth, chronic respiratory disease (asthma on daily medication, COPD, cystic fibrosis) or maternal cardiac disease
- Subjects currently taking insulin sensitizing medications (metformin)
- Subject unable to perform MedGem procedure
- Neonates delivered prior to 34 weeks gestational age will be excluded from analysis by the DEXA scan
- Neonates with fetal anomalies diagnoses in the antenatal period or postpartum will not be included 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
Maternal weight gain, resting metabolic rate (kcal/day)
Time frame: During gestation
Neonatal birth weight (gram), ponderal index
Time frame: After birth
1 secondary outcome
Maternal diet composition, exercise evaluation, insulin resistance, weight gain attitude
Time frame: During gestation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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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.
William Goodnight, MD principal investigator
Medical University of South Carolina
Donna Johnson study chair
Medical University of South Carolina, Obstetrics-Gynecology
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 Medical University of South Carolina 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 7 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: stopped early, as of the sponsor's last update on 18 May 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?
The study was stopped early. Results are not available in the source record.
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?
Maternal weight gain, resting metabolic rate (kcal/day) (time frame: During gestation). The study lists 2 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 18 May 2018.