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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 19, 2008 | ||||
| Last Updated Date | July 18, 2008 | ||||
| Start Date ICMJE | November 2006 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00634764 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Maternal diet composition, exercise evaluation, insulin resistance, weight gain attitude [ Time Frame: During gestation ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Predictors of Maternal Weight Gain and Neonatal Body Composition | ||||
| Official Title ICMJE | Resting Metabolic Rate, Insulin Resistance, and Attitude Towards Weight Gain During Pregnancy to Predict Maternal Weight Gain and Neonatal Body Composition. | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | Pregnant women who present to MUSC's Cannon Place or Prenatal Wellness Center | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | October 2008 | ||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00634764 | ||||
| Responsible Party | William Goodnight, MD, Medical University of South Carolina | ||||
| Study ID Numbers ICMJE | HR # 16751, GCR Protocol # 769 | ||||
| Study Sponsor ICMJE | Medical University of South Carolina | ||||
| Collaborators ICMJE | National Center for Research Resources (NCRR) | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of South Carolina | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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