Actively Recruiting

Phase Not Applicable
FEMALE
Healthy Volunteers
NCT05870878

Generation R Next - Optimaal Opgroeien

Led by Erasmus Medical Center · Updated on 2024-09-04

1750

Participants Needed

1

Research Sites

407 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

I

INDIGO Rijnmond

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Generation R Next - Optimaal Opgroeien

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women and their partners planning a pregnancy or in early pregnancy up to less than 12 weeks
  • Presence of at least one predetermined risk factor
  • Residential address in the municipality of Rotterdam and expected residence there at the birth of their child
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • Temporary or complete withdrawal from participation
  • Gestational age greater than 12 weeks plus 0 days at study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, Netherlands, 3015CN

Actively Recruiting

Loading map...

Research Team

V

Vincent Jaddoe, Dr,.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here