Predictors of Maternal Weight Gain and Neonatal Body Composition

Sponsor

Medical University of South Carolina (Other)

Overall Status

Terminated

CT.gov ID

NCT00634764

Collaborator

National Center for Research Resources (NCRR) (NIH)

Enrollment

Location

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Obesity

Study Design

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 :

Nov 1, 2006

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Pregnant Pregnant women who present to MUSC's Cannon Place or Prenatal Wellness Center

Outcome Measures

Primary Outcome Measures

Maternal weight gain, resting metabolic rate (kcal/day) [During gestation]
Neonatal birth weight (gram), ponderal index [After birth]

Secondary Outcome Measures

Maternal diet composition, exercise evaluation, insulin resistance, weight gain attitude [During gestation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

Principal Investigator: William Goodnight, MD, Medical University of South Carolina
Study Chair: Donna Johnson, Medical University of South Carolina, Obstetrics-Gynecology