Improving birth outcomes through lifestyle changes before and during early pregnancy
Generation R Next - Optimaal Opgroeien
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1750 (estimated) |
| Sex | Female |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05870878 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are beyond 12 weeks of gestation or do not meet the inclusion criteria may not benefit from this study.
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 performed: Other studies have shown promising results with lifestyle interventions in preconception and early pregnancy, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Rotterdam
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.