Generation R Next - Optimaal Opgroeien

Summary

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

• Pregnancy Early
• Outcome, Adverse Birth
• Lifestyle Factors
• Preconception Care
• Pregnancy Outcome
• Pregnancy Complications
• Risk Reduction Behavior

Interventions

OTHER

Standard care

Individual lifestyle consultation

OTHER

Lifestyle program

Lifestyle program focusing on lifestyle advice, coping with stress and adherence to a healthy(er) lifestyle. This program consists of 3 group sessions and an online platform.

Sponsors & Collaborators

• INDIGO Rijnmond

  collaborator UNKNOWN

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Stichting Bevordering van Volkskracht

  collaborator UNKNOWN

• Stichting Achmea Gezondheidszor

  collaborator OTHER

• Bernard van Leer Foundation

  collaborator UNKNOWN

• Ministerie van Volksgezondheid, Welzijn en Sport

  collaborator UNKNOWN

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Vincent Jaddoe, Prof.dr. · Erasmus Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-19

Primary Completion

2026-05-08

Completion

2030-11-08

Countries

• Netherlands

Study Locations