Predictors of Maternal Weight Gain and Neonatal Body Composition

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00634764
First received: February 19, 2008
Last updated: July 18, 2008
Last verified: July 2008
  Purpose

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
Obesity

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Maternal weight gain, resting metabolic rate (kcal/day) [ Time Frame: During gestation ] [ Designated as safety issue: Yes ]
  • Neonatal birth weight (gram), ponderal index [ Time Frame: After birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maternal diet composition, exercise evaluation, insulin resistance, weight gain attitude [ Time Frame: During gestation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2006
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant
Pregnant women who present to MUSC's Cannon Place or Prenatal Wellness Center

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634764

Contacts
Contact: William Goodnight, MD 8437924500 goodniwh@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: William Goodnight, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: William Goodnight, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00634764     History of Changes
Other Study ID Numbers: HR # 16751, GCR Protocol # 769
Study First Received: February 19, 2008
Last Updated: July 18, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014