Generation R Next - Optimaal Opgroeien

Pregnancy Complications Clinical Trial

Official title:

Generation R Next - Optimaal Opgroeien

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870878
• Other study ID #: MEC-2022-0440, NL81446.078.22
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: November 8, 2030

Study information

• Verified date: May 2023
• Source: Erasmus Medical Center
• Contact: Vincent Jaddoe, Dr,.
• Phone: +31107043405
• Email: v.jaddoe[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lifestyle Factors
• Preconception Care
• Pregnancy Complications
• Pregnancy Early
• Pregnancy Outcome
• Risk Reduction Behavior

Intervention

Other:
• Standard care
Individual lifestyle consultation
• Lifestyle 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.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (7)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

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