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Generation R Next - Optimaal Opgroeien

Primary Purpose

Pregnancy Early, Outcome, Adverse Birth, Lifestyle Factors

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Standard care
Lifestyle program
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Early

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Erasmus MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Standard care and additional lifestyle program

Standard care

Arm Description

3 lifestyle group sessions (1 physical and 2 online) and additional online platform and individual consultation given at the research center by trained employees

Individual consultation given at the research center by trained employees

Outcomes

Primary Outcome Measures

Preterm birth
Birth of the child before 37 weeks of pregnancy
Low birthweight/small-for-gestational-age
Birthweight below 10th percentile corrected for gestational age
High birthweight/large-for-gestational-age
Birthweight above 90th percentile corrected for gestational age
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)
Birth weight
Birth weight measured continuously

Secondary Outcome Measures

Adherence to lifestyle advice (mother)
Lifestyle changes assessed via questionnaires during the study period
Sleep/wake rhythm (mother)
Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items
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.
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.
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.
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
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
Time to pregnancy (mother)
Time to pregnancy assessed via questionnaires regarding menstrual period and conception during the study period
Occurrence of miscarriage (mother)
Occurrence of miscarriage assessed via questionnaires during the study period
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
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.
Adherence to lifestyle advice (partner)
Lifestyle changes assessed via questionnaires during the study period
Sleep/wake rhythm (partner)
Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items
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.
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.
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.
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)
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.
Overall health (child)
Overall health of the child assessed via questionnaires during the study period

Full Information

First Posted
March 25, 2023
Last Updated
May 13, 2023
Sponsor
Erasmus Medical Center
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05870878
Brief Title
Generation R Next - Optimaal Opgroeien
Official Title
Generation R Next - Optimaal Opgroeien
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
May 8, 2026 (Anticipated)
Study Completion Date
November 8, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Early, Outcome, Adverse Birth, Lifestyle Factors, Preconception Care, Pregnancy Outcome, Pregnancy Complications, Risk Reduction Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Block randomisation with stratification factor: pregnancy status (yes/no)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care and additional lifestyle program
Arm Type
Experimental
Arm Description
3 lifestyle group sessions (1 physical and 2 online) and additional online platform and individual consultation given at the research center by trained employees
Arm Title
Standard care
Arm Type
Other
Arm Description
Individual consultation given at the research center by trained employees
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Individual lifestyle consultation
Intervention Type
Other
Intervention Name(s)
Lifestyle program
Intervention Description
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 Outcome Measure Information:
Title
Preterm birth
Description
Birth of the child before 37 weeks of pregnancy
Time Frame
Assessed at birth
Title
Low birthweight/small-for-gestational-age
Description
Birthweight below 10th percentile corrected for gestational age
Time Frame
Assessed at birth
Title
High birthweight/large-for-gestational-age
Description
Birthweight above 90th percentile corrected for gestational age
Time Frame
Assessed at birth
Title
Low Apgar-score
Description
Apgar-score assessed 5 minutes after birth, below 7 is considered as low with higher chance on worse outcome (scale: 0-10)
Time Frame
Assessed at birth
Title
Birth weight
Description
Birth weight measured continuously
Time Frame
Assessed at birth
Secondary Outcome Measure Information:
Title
Adherence to lifestyle advice (mother)
Description
Lifestyle changes assessed via questionnaires during the study period
Time Frame
During pregnancy and early childhood, until 12 months
Title
Sleep/wake rhythm (mother)
Description
Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items
Time Frame
During pregnancy and early childhood, until 12 months
Title
Sleep/wake rhythm (mother)
Description
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.
Time Frame
During pregnancy and early childhood, until 12 months
Title
Social support (mother)
Description
Social support assessed via questionnaires during the study period with the Adaptive Functioning Scales Spouse/Partner. 6 items with 6-point Likert scale.
Time Frame
During pregnancy and early childhood, until 12 months
Title
Experience of stress (mother)
Description
Experience of stress assessed via questionnaires during the study period with the brief symptom inventory (BSI). 53 items with 5-point Likert scale.
Time Frame
During pregnancy and early childhood, until 12 months
Title
Weight gain during pregnancy (mother)
Description
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
Time Frame
During pregnancy and early childhood, until 12 months
Title
Weight maintenance after 6 and 12 months pregnancy (mother)
Description
Weight maintenance after 6 and 12 months of pregnancy assessed via questionnaires during the study period
Time Frame
12 months after birth of the child
Title
Time to pregnancy (mother)
Description
Time to pregnancy assessed via questionnaires regarding menstrual period and conception during the study period
Time Frame
At delivery
Title
Occurrence of miscarriage (mother)
Description
Occurrence of miscarriage assessed via questionnaires during the study period
Time Frame
At delivery
Title
Glucose metabolism and diabetes during pregnancy (mother)
Description
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
Time Frame
At delivery
Title
Occurrence of gestational hypertensive disorders during pregnancy (mother)
Description
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.
Time Frame
At delivery
Title
Adherence to lifestyle advice (partner)
Description
Lifestyle changes assessed via questionnaires during the study period
Time Frame
During pregnancy and early childhood, until 12 months
Title
Sleep/wake rhythm (partner)
Description
Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items
Time Frame
During pregnancy and early childhood, until 12 months
Title
Sleep/wake rhythm (partner)
Description
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.
Time Frame
During pregnancy and early childhood, until 12 months
Title
Social support (partner)
Description
Social support assessed via questionnaires during the study period with the Adaptive Functioning Scales Spouse/Partner. 6 items with 6-point Likert scale.
Time Frame
During pregnancy and early childhood, until 12 months
Title
Experience of stress (partner)
Description
Experience of stress assessed via questionnaires during the study period with the brief symptom inventory (BSI). 53 items with 5-point Likert scale.
Time Frame
During pregnancy and early childhood, until 12 months
Title
Growth and adiposity (child)
Description
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)
Time Frame
1, 3, 6 and 12 months of age
Title
Development and behavior (child)
Description
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.
Time Frame
1, 3, 6 and 12 months of age
Title
Overall health (child)
Description
Overall health of the child assessed via questionnaires during the study period
Time Frame
1, 6 and 12 months of age

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Jaddoe, Dr,.
Phone
+31107043405
Email
v.jaddoe@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Jaddoe, Prof.dr.
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015CN
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Jaddoe, MD,PhD
Phone
+31107043405
Email
v.jaddoe@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Romy Gaillard, MD,PhD
Phone
+31107043405
Email
r.gaillard@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Generation R Next - Optimaal Opgroeien

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