Does Dietary and Lifestyle Counseling Prevent Excessive Weight Gain During Pregnancy? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.
研究概览
简要总结
The purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.
详细描述
Excessive gestational weight gain is common with about one third of women gaining more weight in pregnancy than is recommended. Unfortunately, the prevalence of excessive gestational weight gain is increasing. Gestational weight gain greater than that recommended by the Institute of Medicine (IOM) is associated with increased risk of gestational complications (hypertension, diabetes, and preeclampsia), infant macrosomia, and complications in delivery including increased risk of cesarean delivery. Currently, there is no evidence-based prenatal counseling protocol available to prevent excessive gestational weight gain. We hypothesize that consistent counseling on appropriate pregnancy diet, weight gain, and the potential complications of excessive gestational weight gain will result in fewer women gaining above the IOM recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Establish prenatal care at 6 - 16 weeks gestation
- •18-49 years of age
- •Receive their entire prenatal care at the Resident Obstetrics Clinic
- •English and/or Spanish speaking
- •Singleton gestation.
排除标准
- •Establish prenatal care >16 weeks gestation
- •Non-English or non-Spanish speaking
- •Multiple gestation pregnancy
- •Preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight
- •Delivery at institution other than CMC-Main
- •Pregnancy ending in a premature delivery (< 37 weeks)
- •Limited prenatal care (<4 visits)
结局指标
主要结局
The investigators primary outcome is the rate of adherence to the IOM guidelines between our study groups.
时间窗: 3 - 6 months
次要结局
- The investigators secondary outcomes will include the effect of weight gain on mode of delivery, rate of operative vaginal delivery, infant weight, and the incidence of preeclampsia, GDM, vaginal/perineal lacerations, and shoulder dystocia.(3 - 6 months)