Pregnancy EarlyNCT05870878
Generation R Next - Optimaal Opgroeien
A study testing Lifestyle program in people with Pregnancy Early and Outcome, Adverse Birth, run by Erasmus Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Early, Outcome, Adverse Birth, Lifestyle Factors
- What is being tested?
- Lifestyle program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,750 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jan 2023to 8 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women and their partners:
- Temporary or complete withdrawal from participation
- Gestational age > 12+0 at study entry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, 3015CN
Vincent Jaddoe, MD,PhD, +31107043405, v.jaddoe@erasmusmc.nl
Romy Gaillard, MD,PhD, +31107043405, r.gaillard@erasmusmc.nl
About this study
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?
Read more
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.
Read the 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
- Conditions
- Pregnancy Early, Outcome, Adverse Birth, Lifestyle Factors, Preconception Care, Pregnancy Outcome, Pregnancy Complications
- Being tested
- Standard care, Lifestyle program
- Medical subject headings
- Pregnancy Complications, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
Individual lifestyle consultation
Lifestyle programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care and additional lifestyle program | Experimental | 3 lifestyle group sessions (1 physical and 2 online) and additional online platform and individual consultation given at the research center by trained employees Receives: Other: Standard care; Other: Lifestyle program |
| Standard care | Other | Individual consultation given at the research center by trained employees Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth
Birth of the child before 37 weeks of pregnancy
Measured: Assessed at birth
Low birthweight/small-for-gestational-age
Birthweight below 10th percentile corrected for gestational age
Measured: Assessed at birth
High birthweight/large-for-gestational-age
Birthweight above 90th percentile corrected for gestational age
Measured: 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)
Measured: Assessed at birth
Birth weight
Birth weight measured continuously
Measured: Assessed at birth
Secondary outcomes (19)
Adherence to lifestyle advice (mother)
Lifestyle changes assessed via questionnaires during the study period
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At delivery
Occurrence of miscarriage (mother)
Occurrence of miscarriage assessed via questionnaires during the study period
Measured: 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
Measured: 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.
Measured: At delivery
Adherence to lifestyle advice (partner)
Lifestyle changes assessed via questionnaires during the study period
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 1, 3, 6 and 12 months of age
Overall health (child)
Overall health of the child assessed via questionnaires during the study period
Measured: 1, 6 and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start19 Jan 2023
- Primary completion8 May 2026 (estimated)
- Study completion8 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy EarlyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomisation with stratification factor: pregnancy status (yes/no)
- Masking
- None (open label)
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Vincent Jaddoe, Erasmus Medical Center
- Investigators
- Vincent Jaddoe, Prof.dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870878
- Sponsor's protocol ID
- MEC-2022-0440, NL81446.078.22
- Status last verified
- Aug 2024
- First submitted
- 25 Mar 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation R Next - Optimaal Opgroeien
- ClinicalTrials.gov ID
- NCT05870878
- Acronym / sponsor ID
- MEC-2022-0440, NL81446.078.22
- Conditions
- Pregnancy Early, Outcome, Adverse Birth, Lifestyle Factors, Preconception Care, Pregnancy Outcome, Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- 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
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 8 May 2026 (estimated)
- Study completion
- 8 Nov 2030 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomisation with stratification factor: pregnancy status (yes/no)
| Arm | Type | Receives |
|---|---|---|
| Standard care and additional lifestyle program | Experimental | Other: Standard care, Other: Lifestyle program3 lifestyle group sessions (1 physical and 2 online) and additional online platform and individual consultation given at the research center by trained employees |
| Standard care | Other | Other: Standard careIndividual consultation given at the research center by trained employees |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Temporary or complete withdrawal from participation
- Gestational age > 12+0 at study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careIndividual lifestyle consultation | Other | Standard care, Standard care and additional lifestyle program |
| Lifestyle programLifestyle 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. | Other | Standard care and additional lifestyle program |
Primary outcome
Preterm birth
Time frame: Assessed at birth
Birth of the child before 37 weeks of pregnancy
Low birthweight/small-for-gestational-age
Time frame: Assessed at birth
Birthweight below 10th percentile corrected for gestational age
High birthweight/large-for-gestational-age
Time frame: Assessed at birth
Birthweight above 90th percentile corrected for gestational age
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)
Birth weight
Time frame: Assessed at birth
Birth weight measured continuously
19 secondary outcomes
Adherence to lifestyle advice (mother)
Time frame: During pregnancy and early childhood, until 12 months
Sleep/wake rhythm (mother)
Time frame: During pregnancy and early childhood, until 12 months
Sleep/wake rhythm (mother)
Time frame: During pregnancy and early childhood, until 12 months
Social support (mother)
Time frame: During pregnancy and early childhood, until 12 months
Experience of stress (mother)
Time frame: During pregnancy and early childhood, until 12 months
Weight gain during pregnancy (mother)
Time frame: During pregnancy and early childhood, until 12 months
Weight maintenance after 6 and 12 months pregnancy (mother)
Time frame: 12 months after birth of the child
Time to pregnancy (mother)
Time frame: At delivery
Occurrence of miscarriage (mother)
Time frame: At delivery
Glucose metabolism and diabetes during pregnancy (mother)
Time frame: At delivery
Occurrence of gestational hypertensive disorders during pregnancy (mother)
Time frame: At delivery
Adherence to lifestyle advice (partner)
Time frame: During pregnancy and early childhood, until 12 months
Sleep/wake rhythm (partner)
Time frame: During pregnancy and early childhood, until 12 months
Sleep/wake rhythm (partner)
Time frame: During pregnancy and early childhood, until 12 months
Social support (partner)
Time frame: During pregnancy and early childhood, until 12 months
Experience of stress (partner)
Time frame: During pregnancy and early childhood, until 12 months
Growth and adiposity (child)
Time frame: 1, 3, 6 and 12 months of age
Development and behavior (child)
Time frame: 1, 3, 6 and 12 months of age
Overall health (child)
Time frame: 1, 6 and 12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Jaddoe, Prof.dr. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle program in people with Pregnancy Early and Outcome, Adverse Birth, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Jaddoe, Dr,. (+31107043405, v.jaddoe@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth (time frame: Assessed at birth). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.