Improving birth outcomes through lifestyle changes before and during early pregnancy
Official title: Generation R Next - Optimaal Opgroeien
Run by Erasmus Medical Center · NCT05870878 · Data updated 2026-11-12
This study is testing whether helping women improve their lifestyle, nutrition, and stress management before and during early pregnancy can lead to better birth outcomes for both mothers and babies.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 1750 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Status | Recruiting |
| Started | January 19, 2023 |
| Main results expected | May 8, 2026 |
| Study ends | November 8, 2030 |
| Registry record updated | September 4, 2024 |
| Trial ID | NCT05870878 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women planning a pregnancy or in early pregnancy (up to 12 weeks) who have at least one predetermined risk factor and reside in Rotterdam.
✕Probably not a fit
Patients who are beyond 12 weeks of gestation or do not meet the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to enhance birth and long-term outcomes for mothers and children by optimizing lifestyle, nutrition, and stress management during the preconception period and early pregnancy. Participants will receive individual lifestyle consultations and may engage in a tailored lifestyle program that includes dietary recommendations, stress reduction techniques, and adherence to healthy behaviors. The study will compare outcomes between an intervention group and a control group to assess the effectiveness of these lifestyle modifications on birth outcomes and maternal health.
Why it matters
Potential benefit: If successful, this intervention could lead to healthier pregnancies and improved long-term health for both mothers and their children.
How similar studies have gone: Other studies have shown promising results with lifestyle interventions in preconception and early pregnancy, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Erasmus MC
Rotterdam, Netherlands Recruiting
Study contacts
- Principal investigator: Vincent Jaddoe, Prof.dr. — Erasmus Medical Center
- Study coordinator: Vincent Jaddoe, Dr,.
- Email: v.jaddoe@erasmusmc.nl
- Phone: +31107043405
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.