Healthy Living in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,286
- 试验地点
- 6
- 主要终点
- Gestational weight gain
研究概览
简要总结
Multicenter and multidisciplinary public health project in 10 regions of Bavaria, a federal state of Germany, targeting maternal and fetal health. The objective of this trial is to evaluate the efficacy of a lifestyle intervention program focusing on diet, physical activity and weight monitoring during pregnancy. The intervention comprises 4 individual counseling sessions addressing healthy living. Primary outcome: gestational weight gain. Secondary outcomes are pregnancy and obstetric complications like gestational diabetes and rate of caesarean sections as well as offspring health.
The lifestyle intervention program is adapted to the German health care system to allow an immediate implementation after successful evaluation.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational age ≤ 12th week of gestation
- •Age: 18 years to 43 years
- •Prepregnancy BMI ≥ 18.5 kg/m2 and ≤ 40.0 kg/m2
- •Sufficient German language skills
- •Written informed consent
排除标准
- •Multiple pregnancy
- •Any condition preventing physical activity such as placenta praevia, persistent bleeding, cervical incompetence
- •Prepregnancy diabetes or early diagnosed gestational diabetes
- •Uncontrolled chronic diseases (e.g. thyroid dysfunction)
- •Psychiatric or psychosomatic diseases
- •Any condition that may interfere with the study protocol
结局指标
主要结局
Gestational weight gain
时间窗: 4 years
Proportion of pregnant women showing excessive gestational weight gain according to Institute of Medicine (IOM) guidelines
次要结局
未报告次要终点