Weight Management for Improved Pregnancy Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Maternal Weight Change
研究概览
简要总结
This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 30 or more
- •Less than 20 weeks gestation
- •member of Kaiser Permanente Northwest (NW)
- •receive pre-natal care at Kaiser Permanente NW
- •speaks English
排除标准
- •no current treatment for cancer
- •no bariatric surgery
- •no current renal disease
- •no multiple birth anticipated
- •no hyperemesis requiring hospitalization
- •no diabetes (type 1 or 2)
结局指标
主要结局
Maternal Weight Change
时间窗: baseline to 2 weeks post partum
We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.
次要结局
- Large for Gestational Age (LGA)(At birth)
- Pregnancy Weight Change(baseline to 34 weeks gestation)