Generation R Next - Optimaal Opgroeien
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Early
- Sponsor
- Erasmus Medical Center
- Enrollment
- 1750
- Primary Endpoint
- High birthweight/large-for-gestational-age
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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. Prior to randomization, the intervention and control groups will be offered an individual lifestyle consultation for both women and men, and, if pregnant, an early pregnancy ultrasound. After randomization, there will be two groups: the intervention group and the control group. Both groups will receive standard care, including an individual lifestyle consultation in line with current national standards for preconception and early pregnancy. The intervention group will additionally attend three group sessions (online and physical) focused on health during preconception and early pregnancy, coping with stress and adherence to a healthy lifestyle. The advices are based on national guidelines for health during the preconception period and early pregnancy. Compliance with the prescribed advice is encouraged via newly developed digital platform
Investigators
Vincent Jaddoe
Prof. dr.
Erasmus Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Women and their partners:
- •Temporary or complete withdrawal from participation
- •Gestational age \> 12+0 at study entry
Outcomes
Primary Outcomes
High birthweight/large-for-gestational-age
Time Frame: Assessed at birth
Birthweight above 90th percentile corrected for gestational age
Birth weight
Time Frame: Assessed at birth
Birth weight measured continuously
Low Apgar-score
Time Frame: 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
Time Frame: Assessed at birth
Birth of the child before 37 weeks of pregnancy
Low birthweight/small-for-gestational-age
Time Frame: Assessed at birth
Birthweight below 10th percentile corrected for gestational age
Secondary Outcomes
- Sleep/wake rhythm (mother)(During pregnancy and early childhood, until 12 months)
- 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)
- Sleep/wake rhythm (partner)(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)