Lifestyle Factors, Outcome, Adverse Birth, Preconception Care, Pregnancy Complications, Pregnancy Early, Pregnancy Outcome, Risk Reduction Behavior
Conditions
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
Interventions
OTHERStandard care
Individual lifestyle consultation
OTHERLifestyle program
Lifestyle program focusing on lifestyle advice, coping with stress and adherence to a healthy(er) lifestyle. This program consists of 3 group sessions and an online platform.
Sponsors
INDIGO Rijnmond
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Bevordering van Volkskracht
Stichting Achmea Gezondheidszor
Bernard van Leer Foundation
Ministerie van Volksgezondheid, Welzijn en Sport
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Block randomisation with stratification factor: pregnancy status (yes/no)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth | Assessed at birth | Birth of the child before 37 weeks of pregnancy |
| Low birthweight/small-for-gestational-age | Assessed at birth | Birthweight below 10th percentile corrected for gestational age |
| High birthweight/large-for-gestational-age | Assessed at birth | Birthweight above 90th percentile corrected for gestational age |
| Low Apgar-score | 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) |
| Birth weight | Assessed at birth | Birth weight measured continuously |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight maintenance after 6 and 12 months pregnancy (mother) | 12 months after birth of the child | Weight maintenance after 6 and 12 months of pregnancy assessed via questionnaires during the study period |
| Time to pregnancy (mother) | At delivery | Time to pregnancy assessed via questionnaires regarding menstrual period and conception during the study period |
| Occurrence of miscarriage (mother) | At delivery | Occurrence of miscarriage assessed via questionnaires during the study period |
| Glucose metabolism and diabetes during pregnancy (mother) | At delivery | Glucose metabolism assessed via taken blood samples (measured: glucose in mmol/L, normal range: 4-8 mmol/L) at visits in first trimester and 30 weeks of pregnancy |
| Occurrence of gestational hypertensive disorders during pregnancy (mother) | At delivery | Occurrence of gestational hypertensive disorders assessed via questionnaires during the study period and with blood pressure measurements during the pregnancy visits at the research center measured in systolic and diastolic millimetre of mercury (mmHg). Cutoff values: 140 systolic and 80 diastolic. |
| Adherence to lifestyle advice (partner) | During pregnancy and early childhood, until 12 months | Lifestyle changes assessed via questionnaires during the study period |
| Adherence to lifestyle advice (mother) | During pregnancy and early childhood, until 12 months | Lifestyle changes assessed via questionnaires during the study period |
| Social support (partner) | During pregnancy and early childhood, until 12 months | Social support assessed via questionnaires during the study period with the Adaptive Functioning Scales Spouse/Partner. 6 items with 6-point Likert scale. |
| Experience of stress (partner) | During pregnancy and early childhood, until 12 months | Experience of stress assessed via questionnaires during the study period with the brief symptom inventory (BSI). 53 items with 5-point Likert scale. |
| Growth and adiposity (child) | 1, 3, 6 and 12 months of age | Growth of the child assessed via questionnaires during the study period and via weight and height measurements at the consultation office (unit: kilograms and centimeters) |
| Development and behavior (child) | 1, 3, 6 and 12 months of age | Development and behavior of the child assessed via questionnaires during the study period (Child Development Inventory. 30 items) and via behavioral assessment at the consultation office. |
| Overall health (child) | 1, 6 and 12 months of age | Overall health of the child assessed via questionnaires during the study period |
| Sleep/wake rhythm (partner) | During pregnancy and early childhood, until 12 months | Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items |
| Sleep/wake rhythm (mother) | During pregnancy and early childhood, until 12 months | Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items |
| Social support (mother) | During pregnancy and early childhood, until 12 months | Social support assessed via questionnaires during the study period with the Adaptive Functioning Scales Spouse/Partner. 6 items with 6-point Likert scale. |
| Experience of stress (mother) | During pregnancy and early childhood, until 12 months | Experience of stress assessed via questionnaires during the study period with the brief symptom inventory (BSI). 53 items with 5-point Likert scale. |
| Weight gain during pregnancy (mother) | During pregnancy and early childhood, until 12 months | Weight gain during pregnancy assessed via questionnaires during the study period and with weight measurements during the pregnancy visits at the research center measured in kilogram |
Countries
Netherlands
Contacts
Primary ContactVincent Jaddoe, Dr,.
Outcome results
None listed