Clinical trial Recruiting at 1 site Interventional Women only

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 typeInterventional
SexWomen only
Enrollment1750 (estimated)
SponsorErasmus Medical Center
Academic / other
Locations1 site (Rotterdam)
StatusRecruiting
StartedJanuary 19, 2023
Main results expectedMay 8, 2026
Study endsNovember 8, 2030
Registry record updatedSeptember 4, 2024
Trial IDNCT05870878 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.