Ease of Access to Nutritional Services and the Effect on Maternal Weight in an Obese Urban Population
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Weight gain
研究概览
简要总结
The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. There are many studies that have shown that obesity has a negative impact on pregnancy. However, currently there are only a few small studies that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on maternal weight gain and pregnancy outcomes. This study will compare two groups of pregnant women with a BMI of 30 or greater. The investigators hypothesize that access to nutritional services will lead to decreased weight gain during pregnancy and improved pregnancy outcomes.
详细描述
The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. Approximately one fourth of women in the United States are overweight and nearly one third are considered to be obese. Pregnancy places obese women at increased risk for several adverse events in the antepartum, intrapartum, and postpartum period. There are many studies that have shown that obesity in pregnancy has a negative impact on pregnancy. However, currently there are few studies in the United States that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on pregnancy outcomes. This study will be a randomized controlled study that will compare two groups of pregnant women with a BMI of 30 or greater one of which has access to nutritional services along with routine prenatal care while the other gets only routine prenatal care. The investigators hypothesize that the obese parturient who has access to nutritional services will have decreased weight gain during pregnancy and ultimately have improved pregnancy outcomes. This will help to guide future care for the obese parturient in the urban population who may have limited access to services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primigravid women
- •age 19-40yrs
- •less than or equal to 18 weeks gestation at time of enrollment
- •body mass index (BMI) greater than or equal to 30
排除标准
- •multiparous women
- •less than 19 yrs of age or older than 40
- •greater than 18 weeks gestation at time of enrollment
- •body mass index (BMI) less than 30
- •any significant past medical history including hypertension, diabetes, renal disease, coagulopathy
- •past surgical history of gastric bypass/weight loss surgery
结局指标
主要结局
Weight gain
时间窗: one year
change in weight from baseline prepregnancy weight
次要结局
- Birth weight(40 weeks)
- Fetal anomalies(40 weeks)
- Hypertensive disease of pregnancy(40 weeks)
- Gestational diabetes(40 weeks)
- Neonatal intensive care admission(28 days)
- APGAR scores(At birth)
- Mode of delivery(40 weeks)
- Intrauterine Fetal Demise(40 weeks)
- Neonatal Death(28 days)
研究者
Erin M. Murphy, MD
Principal Investigator
Abington Memorial Hospital