Promoting Health in Pregnancy and Postpartum Among Overweight/Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Gestational weight gain in pounds
研究概览
简要总结
The purpose of this study is to examine the impact of a lifestyle intervention on gestational weight gain, postpartum weight loss, and other secondary outcomes relative to a usual care control group.
详细描述
Our study will address the following specific aims: (1) examine the impact of a lifestyle intervention on gestational weight gain and postpartum weight loss in overweight and obese women, (2) examine the impact of the intervention on physical activity (PA), dietary intake, and quality of life (QOL), (3) examine race differences in total gestational weight gain, PA, dietary intake, and QOL; and (4) examine the impact of the intervention on offspring adiposity.
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •White or African American woman
- •Overweight or obese (prepregnancy BMI: 25-45 kg/m2)
- •≤ 16 wks gestation at screening
- •Age 18-44 years
- •No plan to move out of the greater Columbia area in next 18 months
- •Regular and consistent telephone access
- •Availability for telephone calls
- •Willing to accept random assignment
排除标准
- •Uncontrolled hypertension
- •Fetal anomaly
- •Taking insulin for diabetes
- •Uncontrolled or untreated thyroid disease
- •Mental health or substance-abuse hospitalization in last 6 months
- •Multiple gestation
- •Persistent bleeding in the first trimester
- •History of more than 3 miscarriages
- •History of an eating disorder or current eating disorder
- •History of an incompetent cervix
- •Physical disability that prevents exercise
- •Told by health care provider not to exercise
- •Any other medical conditions that might be a contraindication to exercise or dietary change
结局指标
主要结局
Gestational weight gain in pounds
时间窗: Delivery
Defined as delivery room weight minus pre-pregnancy weight
次要结局
- Dietary intake(12 months postpartum)
- Depressive Symptoms(12 months postpartum)
- Child Adiposity(12 months postpartum)
- Gestational weight gain category(Delivery)
- Postpartum weight retention(Weight retained at the 12 month postpartum visit)
- Health-Related Quality of Life(12 months postpartum)
- Physical Activity(12 months postpartum)
研究者
Sara Wilcox
Professor
University of South Carolina