Generation R Next - Optimaal Opgroeien
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,750
- 试验地点
- 1
- 主要终点
- High birthweight/large-for-gestational-age
研究概览
简要总结
The aim of this randomized controlled trial is to improve birth outcomes and long-term outcomes in mother and child by optimizing lifestyle,nutrition and stress experience in the preconception period and early pregnancy in women and men
The main research question that will be addressed is: Does an intervention focused on optimizing preconception and early pregnancy lifestyle, nutrition and stress improve the birth outcomes and long-term outcomes in mother and child?
Participants will receive an individual lifestyle consultation at the start of the study. Depending on their study arm, participants will receive an additional lifestyle program focused on health during preconception and early pregnancy, coping with stress and adherence to a healthy(er) lifestyle. The given advices are based on national guidelines.
Researchers will compare the intervention group and control group to see if (adherence to) this lifestyle program improve birth outcomes and long-term outcomes in mother and child.
详细描述
Preconception and early pregnancy are critical periods for health and wellbeing across the full life course in the offspring. Improving lifestyle, nutrition and stress in both women and their partners already from the preconception period onwards may have beneficial effects on the offspring.
This RCT will include preconception/early pregnancy integrated life style intervention focused on a healthy weight (BMI: 18.5-25 kg/m2), stopping alcohol/smoking/drugs, supplementing folic acid and vitamin D, a healthy diet (weekly fish, iron and vitamin C rich food) and stress reduction. Reducing stress appears to be effective for improving (maternal) health and reducing risk behavior. Mind-body therapy, a combination of yoga exercises and mindfulness seems to be a popular intervention, especially among pregnant women or women of childbearing age from various ethnic backgrounds.
The use of the preconception consultation is not yet optimal. This is partly due to the difficulty of reaching (vulnerable) groups and the limited insight regarding the efficacy.
The aim of this randomized controlled trial is to improve birth outcomes and long-term outcomes in mother and child by optimizing lifestyle in the preconception period and early pregnancy in women and men. The main research question is whether an intervention focused on optimizing preconception and early pregnancy lifestyle, nutrition and stress improves the birth outcomes and long-term outcomes in mother and child?
This RCT will be embedded in the available Generation R Next research infrastructure.
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
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women and their parents:
- •Planning a pregnancy or early pregnancy up to < 12 weeks
- •With the presence of at least one of the predetermined risk factors
- •Residential address in the municipality of Rotterdam and expected residential address in the municipality of Rotterdam at the birth of their child
- •Consent for participation
排除标准
- •Women and their partners:
- •Temporary or complete withdrawal from participation
- •Gestational age > 12+0 at study entry
结局指标
主要结局
High birthweight/large-for-gestational-age
时间窗: Assessed at birth
Birthweight above 90th percentile corrected for gestational age
Birth weight
时间窗: Assessed at birth
Birth weight measured continuously
Low Apgar-score
时间窗: Assessed at birth
Apgar-score assessed 5 minutes after birth, below 7 is considered as low with higher chance on worse outcome (scale: 0-10)
Preterm birth
时间窗: Assessed at birth
Birth of the child before 37 weeks of pregnancy
Low birthweight/small-for-gestational-age
时间窗: Assessed at birth
Birthweight below 10th percentile corrected for gestational age
次要结局
- Time to pregnancy (mother)(At delivery)
- Adherence to lifestyle advice (partner)(During pregnancy and early childhood, until 12 months)
- Social support (partner)(During pregnancy and early childhood, until 12 months)
- Growth and adiposity (child)(1, 3, 6 and 12 months of age)
- Overall health (child)(1, 6 and 12 months of age)
- Social support (mother)(During pregnancy and early childhood, until 12 months)
- Weight maintenance after 6 and 12 months pregnancy (mother)(12 months after birth of the child)
- Adherence to lifestyle advice (mother)(During pregnancy and early childhood, until 12 months)
- Experience of stress (mother)(During pregnancy and early childhood, until 12 months)
- Occurrence of gestational hypertensive disorders during pregnancy (mother)(At delivery)
- Development and behavior (child)(1, 3, 6 and 12 months of age)
- Weight gain during pregnancy (mother)(During pregnancy and early childhood, until 12 months)
- Occurrence of miscarriage (mother)(At delivery)
- Glucose metabolism and diabetes during pregnancy (mother)(At delivery)
- Experience of stress (partner)(During pregnancy and early childhood, until 12 months)
- Sleep/wake rhythm (partner)(During pregnancy and early childhood, until 12 months)
- Sleep/wake rhythm (mother)(During pregnancy and early childhood, until 12 months)
研究者
Vincent Jaddoe
Prof. dr.
Erasmus Medical Center