Preventing Excessive Gestational Weight Gain in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 4
- 主要终点
- Weight Gain Per Week of Observation
研究概览
简要总结
The purpose of this study is to study the effects of a multicomponent lifestyle intervention that includes partial meal replacements as a means to prevent excessive gestational weight gain in obese women. The primary hypothesis is that the intervention will reduce the rate of gestational weight gain compared with standard care.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years old
- •< 16 weeks gestation
- •BMI >= 25
- •Willing to consent
排除标准
- •Pregnant with Twins
- •Untreated medical or psychological problem
- •Inability to be physically active
结局指标
主要结局
Weight Gain Per Week of Observation
时间窗: 13 weeks gestation, 35 weeks gestation
Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.
次要结局
- Number of Women Exceeding IOM Guidelines as a Proportion of Total Number of Women in Each Group.(13 weeks, 40 weeks)
- Offspring Weight Gain(1 week, 6 months, 12 months)
- Changes in Maternal Glucose(13 weeks gestation, 34 weeks gestation)
- Kcals/Day(13 weeks gestation, 34 weeks gestation)
- Changes in Offspring Dietary Intake(1 week, 6 months, 12 months)
- Number of Women at or Below Prepregnancy Weight as a Proportion of the Total Number of Participants in Each Group(48-56 weeks post delivery)
研究者
Suzanne Phelan
Principle Investigator
California Polytechnic State University-San Luis Obispo