PrepareD: Examining Post-Delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Child body mass index (BMI) from birth up to 5 years of age
研究概览
简要总结
The goal of PrepareD is to examine whether the prepregnancy weight-loss intervention administered during the Prepare trial [NCT02346162] has an influence in the postnatal period. PrepareD is a cohort study (no intervention) that will address new specific aims through one in-person visit with mothers and children, dietary recalls, actigraphy, and the use of medical record weights. The goal is to collect data when the child is 3 years old. However, due to the COVID-19 pandemic, the investigators expanded the data collection window in order to collect data up to when the child is 5 years old. The investigators hypothesize that intervening on women before pregnancy is the key to breaking the multigenerational cycle of obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mother must be a Prepare [NCT02346162] participant who has experienced a viable pregnancy during the Prepare trial
- •Child must be the first viable offspring born to a Prepare participant after consent into the Prepare study
排除标准
- 未提供
结局指标
主要结局
Child body mass index (BMI) from birth up to 5 years of age
时间窗: Birth up to 5 years of age
All child weights, lengths (before age 2), and heights (after age 2) recorded in the electronic medical record (EMR) between delivery and up to 5 years of age will be collected. Child weight and height between 3 years 0 months of age up until 5 years of age will be measured at an in-person research visit. Weight in kilograms (kg) and height in meters (m) will be combined to report BMI in kg/m\^2.
Mother postpartum weight retention (PPWR) in pounds at 5 weeks and 1 year postpartum
时间窗: 5 weeks and 1 year after delivery
All weights recorded for the mother in the EMR between delivery and up to 5 weeks and 1 year postpartum will be collected. PPWR at 5 weeks and 1 year after delivery will be obtained by subtracting mother's 5-week postpartum weight (in lbs) and 1-year postpartum weight (in lbs) from mother's weight (in lbs) at delivery, respectively.
次要结局
- Healthy Eating Index (HEI) score for mother and child(At study visit, when child is 3-4 years of age)
- Daily activity level for mother and child(At study visit, when child is 3-4 years of age)