Generation R Next - Optimaal Opgroeien

Study Overview
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Brief Summary
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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
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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

Official Title
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Generation R Next - Optimaal Opgroeien

Conditions
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Outcome, Adverse Birth, Lifestyle Factors, Preconception Care, Pregnancy Complications, Pregnancy Early, Pregnancy Outcome, Risk Reduction Behavior

Intervention / Treatment
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* Other: Standard care
* Other: Lifestyle program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomisation with stratification factor: pregnancy status (yes/no)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard care and additional lifestyle program<br>3 lifestyle group sessions (1 physical and 2 online) and additional online platform and individual consultation given at the research center by trained employees | Other: Standard care<br>* Individual lifestyle consultation<br>Other: Lifestyle program<br>* 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.<br>|
| Other: Standard care<br>Individual consultation given at the research center by trained employees | Other: Standard care<br>* Individual lifestyle consultation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth | Birth of the child before 37 weeks of pregnancy | Assessed at birth | 
| Low birthweight/small-for-gestational-age | Birthweight below 10th percentile corrected for gestational age | Assessed at birth | 
| High birthweight/large-for-gestational-age | Birthweight above 90th percentile corrected for gestational age | Assessed at birth | 
| 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 | 
| Birth weight | Birth weight measured continuously | Assessed at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to lifestyle advice (mother) | Lifestyle changes assessed via questionnaires during the study period | During pregnancy and early childhood, until 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Time to pregnancy (mother) | Time to pregnancy assessed via questionnaires regarding menstrual period and conception during the study period | At delivery | 
| Occurrence of miscarriage (mother) | Occurrence of miscarriage assessed via questionnaires during the study period | At delivery | 
| 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 | 
| 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 | 
| Adherence to lifestyle advice (partner) | Lifestyle changes assessed via questionnaires during the study period | During pregnancy and early childhood, until 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Overall health (child) | Overall health of the child assessed via questionnaires during the study period | 1, 6 and 12 months of age |