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NCT Number: NCT05870878

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.

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Key information

Conditions

Pregnancy Early Behavior Female Urogenital Diseases and Pregnancy Complications Lifestyle Factors Outcome, Adverse Birth Preconception Care Pregnancy Complications Pregnancy Outcome Risk Reduction Behavior Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

Individual lifestyle consultation

Lifestyle program

Other

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.

Primary outcomes

  1. Preterm birth

    Time frame: Assessed at birth

    Birth of the child before 37 weeks of pregnancy

  2. Low birthweight/small-for-gestational-age

    Time frame: Assessed at birth

    Birthweight below 10th percentile corrected for gestational age

  3. High birthweight/large-for-gestational-age

    Time frame: Assessed at birth

    Birthweight above 90th percentile corrected for gestational age

  4. 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)

  5. Birth weight

    Time frame: Assessed at birth

    Birth weight measured continuously

Secondary outcomes

  1. Adherence to lifestyle advice (mother)

    Time frame: During pregnancy and early childhood, until 12 months

    Lifestyle changes assessed via questionnaires during the study period

  2. Sleep/wake rhythm (mother)

    Time frame: 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

  3. Sleep/wake rhythm (mother)

    Time frame: During pregnancy and early childhood, until 12 months

    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.

  4. Social support (mother)

    Time frame: 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.

  5. Experience of stress (mother)

    Time frame: 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.

  6. Weight gain during pregnancy (mother)

    Time frame: 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

  7. Weight maintenance after 6 and 12 months pregnancy (mother)

    Time frame: 12 months after birth of the child

    Weight maintenance after 6 and 12 months of pregnancy assessed via questionnaires during the study period

  8. Time to pregnancy (mother)

    Time frame: At delivery

    Time to pregnancy assessed via questionnaires regarding menstrual period and conception during the study period

  9. Occurrence of miscarriage (mother)

    Time frame: At delivery

    Occurrence of miscarriage assessed via questionnaires during the study period

  10. Glucose metabolism and diabetes during pregnancy (mother)

    Time frame: 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

  11. Occurrence of gestational hypertensive disorders during pregnancy (mother)

    Time frame: 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.

  12. Adherence to lifestyle advice (partner)

    Time frame: During pregnancy and early childhood, until 12 months

    Lifestyle changes assessed via questionnaires during the study period

  13. Sleep/wake rhythm (partner)

    Time frame: 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

  14. Sleep/wake rhythm (partner)

    Time frame: During pregnancy and early childhood, until 12 months

    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.

  15. Social support (partner)

    Time frame: 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.

  16. Experience of stress (partner)

    Time frame: 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.

  17. Growth and adiposity (child)

    Time frame: 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)

  18. Development and behavior (child)

    Time frame: 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.

  19. Overall health (child)

    Time frame: 1, 6 and 12 months of age

    Overall health of the child assessed via questionnaires during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent Jaddoe, Dr,.

CONTACT

[email protected]

+31107043405

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
May 23, 2023
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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