Generation R Next - Optimaal Opgroeien

NCT05870878 | Recruiting

• 1 other identifier: MEC-2022-0440, NL81446.078.22
• Study Type: interventional
• Target: 1,750
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Preterm birth

  Birth of the child before 37 weeks of pregnancy

  Assessed at birth

• Low birthweight/small-for-gestational-age

  Birthweight below 10th percentile corrected for gestational age

  Assessed at birth

• High birthweight/large-for-gestational-age

  Birthweight above 90th percentile corrected for gestational age

  Assessed at birth

• Low Apgar-score

  Apgar-score assessed 5 minutes after birth, below 7 is considered as low with higher chance on worse outcome (scale: 0-10)

  Assessed at birth

• Birth weight

  Birth weight measured continuously

  Assessed at birth

Secondary Outcomes (19)

• Adherence to lifestyle advice (mother)

  During pregnancy and early childhood, until 12 months

• Sleep/wake rhythm (mother)

  During pregnancy and early childhood, until 12 months

• Sleep/wake rhythm (mother)

  During pregnancy and early childhood, until 12 months

• Social support (mother)

  During pregnancy and early childhood, until 12 months

• Experience of stress (mother)

  During pregnancy and early childhood, until 12 months

Study Arms (2)

Standard care and additional lifestyle program

EXPERIMENTAL

3 lifestyle group sessions (1 physical and 2 online) and additional online platform and individual consultation given at the research center by trained employees

Other: Standard care; Other: Lifestyle program

Standard care

OTHER

Individual consultation given at the research center by trained employees

Other: Standard care

Interventions

Standard care OTHER

Individual lifestyle consultation

Standard care; Standard care and additional lifestyle program

Lifestyle program OTHER

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.

Standard care and additional lifestyle program

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women and their partners:
• Temporary or complete withdrawal from participation
• Gestational age \> 12+0 at study entry

Sponsors & Collaborators

• Erasmus Medical Center: lead
• INDIGO Rijnmond: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Stichting Bevordering van Volkskracht: collaborator
• Stichting Achmea Gezondheidszor: collaborator
• Bernard van Leer Foundation: collaborator
• Ministerie van Volksgezondheid, Welzijn en Sport: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, 3015CN, Netherlands

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Risk Reduction Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Vincent Jaddoe, Prof.dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Jaddoe, Dr,.

CONTACT

+31107043405; v.jaddoe@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Block randomisation with stratification factor: pregnancy status (yes/no)

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: May 23, 2023
• Study Start: January 19, 2023
• Primary Completion (Estimated): May 8, 2026
• Study Completion (Estimated): November 8, 2030
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)