Interventions to Reduce Excess Weight Gain in Pregnancy in Overweight and Obese Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Maternal and Infant Body Weight Change
研究概览
简要总结
The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years
- •In first trimester of pregnancy
- •Must be willing to not join any other weight control program while in the study
- •BMI of 25-40 kg/m2
- •Willingness and ability to attend support group meetings either in person or via web
- •Must be able to read, speak, and understand English
排除标准
- •Carrying multiple fetuses
- •Gestational diabetes mellitus at study entry
- •Type 2 diabetes mellitus or blood glucose >125 mg/dl at screening
- •Self reported current substance abuse
- •Current smoking
- •Alchol consumption of more than 1 drink per day
- •Preexisting medical conditions (includes bariatric surgery) or use of medications that would impact study involvement or outcomes testing
- •Eating disorder in the past 2 years
- •Depression or diagnosis of bipolar disorder
- •Concurrent participation in any other research study that would impact participation in this investigation
研究组 & 干预措施
Fiber Cereal
Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided high fiber cereal to manage hunger.
干预措施: Intervention to reduce excess weight gain during pregnancy (Behavioral)
Control Group
Women assigned to this arm of the study will receive routine clinical care and no additional interventions.
Resistant Starch
Women assigned to this arm will receive the group based behavioral intervention plus the recommendation to consume provided resistant starch to control hunger
干预措施: Intervention to reduce excess weight gain during pregnancy (Behavioral)
结局指标
主要结局
Maternal and Infant Body Weight Change
时间窗: From first trimester through 1 year post-partum
* Maternal non-fasting weight measured at all prenatal clinic and study visits. * Infant weight measured at birth and all pediatric clinic visits through 1 year.
次要结局
- Infant Outcomes(From birth through first year)
- Maternal and Perinatal Outcomes(First trimester through 1 year post-partum)
研究者
Susan Roberts
Director, Energy Metabolism Laboratory
Tufts University