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NCT05870878

Generation R Next - Optimaal Opgroeien

Recruiting now NA Last updated 4 September 2024
What this trial tests

NA trial testing Standard care in Pregnancy Early in 1,750 participants. Currently enrolling.

Timeline
19 January 2023
Primary endpoint
8 May 2026
8 November 2030

Quick facts

Lead sponsorErasmus Medical Center
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,750
Start date19 January 2023
Primary completion8 May 2026
Estimated completion8 November 2030
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Erasmus Medical Center

Who can join

Eligibility, female only, with Pregnancy Early or Outcome, Adverse Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Standard care

Trials testing the same drug.

Other Erasmus Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05870878.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing