Predictors of Maternal Weight Gain and Neonatal Body Composition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00634764
Recruitment Status : Terminated
First Posted : March 13, 2008
Last Update Posted : May 18, 2018
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Medical University of South Carolina

Brief 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. 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.

Condition or disease

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Resting Metabolic Rate, Insulin Resistance, and Attitude Towards Weight Gain During Pregnancy to Predict Maternal Weight Gain and Neonatal Body Composition.
Actual Study Start Date : November 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Pregnant women who present to MUSC's Cannon Place or Prenatal Wellness Center

Primary Outcome Measures :
  1. Maternal weight gain, resting metabolic rate (kcal/day) [ Time Frame: During gestation ]
  2. Neonatal birth weight (gram), ponderal index [ Time Frame: After birth ]

Secondary Outcome Measures :
  1. Maternal diet composition, exercise evaluation, insulin resistance, weight gain attitude [ Time Frame: During gestation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00634764

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Center for Research Resources (NCRR)
Principal Investigator: William Goodnight, MD Medical University of South Carolina
Study Chair: Donna Johnson Medical University of South Carolina, Obstetrics-Gynecology

Responsible Party: Medical University of South Carolina Identifier: NCT00634764     History of Changes
Other Study ID Numbers: HR # 16751
GCR Protocol # 769
First Posted: March 13, 2008    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Keywords provided by Medical University of South Carolina:
Maternal weight gain
Neonatal birth weight
Weight gain attitude
Body fat
Maternal Behavior
Birth outcomes

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms