Pregnancy Complications Clinical Trial
Official title:
Generation R Next - Optimaal Opgroeien
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.
Status | Recruiting |
Enrollment | 1750 |
Est. completion date | November 8, 2030 |
Est. primary completion date | May 8, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus MC | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Bernard van Leer Foundation, INDIGO Rijnmond, Ministerie van Volksgezondheid, Welzijn en Sport, Stichting Achmea Gezondheidszor, Stichting Bevordering van Volkskracht, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preterm birth | Birth of the child before 37 weeks of pregnancy | Assessed at birth | |
Primary | Low birthweight/small-for-gestational-age | Birthweight below 10th percentile corrected for gestational age | Assessed at birth | |
Primary | High birthweight/large-for-gestational-age | Birthweight above 90th percentile corrected for gestational age | Assessed at birth | |
Primary | Low Apgar-score | Apgar-score assessed 5 minutes after birth, below 7 is considered as low with higher chance on worse outcome (scale: 0-10) | Assessed at birth | |
Primary | Birth weight | Birth weight measured continuously | Assessed at birth | |
Secondary | Adherence to lifestyle advice (mother) | Lifestyle changes assessed via questionnaires during the study period | During pregnancy and early childhood, until 12 months | |
Secondary | Sleep/wake rhythm (mother) | Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items | During pregnancy and early childhood, until 12 months | |
Secondary | Sleep/wake rhythm (mother) | Sleep/wake rhythm assessed via questionnaires during the study period with the General Sleep Disturbances Questionnaire. 22 items, responses are given on an eight-point scale ranging from 0 (no days) to 7 (every day). The total score for the scale ranges between 0 and 154, with higher scores indicating a higher frequency of sleep disturbances. | During pregnancy and early childhood, until 12 months | |
Secondary | Social support (mother) | Social support assessed via questionnaires during the study period with the Adaptive Functioning Scales Spouse/Partner. 6 items with 6-point Likert scale. | During pregnancy and early childhood, until 12 months | |
Secondary | Experience of stress (mother) | Experience of stress assessed via questionnaires during the study period with the brief symptom inventory (BSI). 53 items with 5-point Likert scale. | During pregnancy and early childhood, until 12 months | |
Secondary | Weight gain during pregnancy (mother) | 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 | During pregnancy and early childhood, until 12 months | |
Secondary | Weight maintenance after 6 and 12 months pregnancy (mother) | Weight maintenance after 6 and 12 months of pregnancy assessed via questionnaires during the study period | 12 months after birth of the child | |
Secondary | Time to pregnancy (mother) | Time to pregnancy assessed via questionnaires regarding menstrual period and conception during the study period | At delivery | |
Secondary | Occurrence of miscarriage (mother) | Occurrence of miscarriage assessed via questionnaires during the study period | At delivery | |
Secondary | Glucose metabolism and diabetes during pregnancy (mother) | 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 | At delivery | |
Secondary | Occurrence of gestational hypertensive disorders during pregnancy (mother) | 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. | At delivery | |
Secondary | Adherence to lifestyle advice (partner) | Lifestyle changes assessed via questionnaires during the study period | During pregnancy and early childhood, until 12 months | |
Secondary | Sleep/wake rhythm (partner) | Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items | During pregnancy and early childhood, until 12 months | |
Secondary | Sleep/wake rhythm (partner) | Sleep/wake rhythm assessed via questionnaires during the study period with the General Sleep Disturbances Questionnaire. 22 items, responses are given on an eight-point scale ranging from 0 (no days) to 7 (every day). The total score for the scale ranges between 0 and 154, with higher scores indicating a higher frequency of sleep disturbances. | During pregnancy and early childhood, until 12 months | |
Secondary | Social support (partner) | Social support assessed via questionnaires during the study period with the Adaptive Functioning Scales Spouse/Partner. 6 items with 6-point Likert scale. | During pregnancy and early childhood, until 12 months | |
Secondary | Experience of stress (partner) | Experience of stress assessed via questionnaires during the study period with the brief symptom inventory (BSI). 53 items with 5-point Likert scale. | During pregnancy and early childhood, until 12 months | |
Secondary | Growth and adiposity (child) | 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) | 1, 3, 6 and 12 months of age | |
Secondary | Development and behavior (child) | 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. | 1, 3, 6 and 12 months of age | |
Secondary | Overall health (child) | Overall health of the child assessed via questionnaires during the study period | 1, 6 and 12 months of age |
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