Generation R Next - Optimaal Opgroeien

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-19

Study Completion Date

2030-11-08

Brief Summary

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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.

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Detailed Description

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Preconception and early pregnancy are critical periods for health and wellbeing across the full life course in the offspring. Improving lifestyle, nutrition and stress in both women and their partners already from the preconception period onwards may have beneficial effects on the offspring.

This RCT will include preconception/early pregnancy integrated life style intervention focused on a healthy weight (BMI: 18.5-25 kg/m2), stopping alcohol/smoking/drugs, supplementing folic acid and vitamin D, a healthy diet (weekly fish, iron and vitamin C rich food) and stress reduction. Reducing stress appears to be effective for improving (maternal) health and reducing risk behavior. Mind-body therapy, a combination of yoga exercises and mindfulness seems to be a popular intervention, especially among pregnant women or women of childbearing age from various ethnic backgrounds.

The use of the preconception consultation is not yet optimal. This is partly due to the difficulty of reaching (vulnerable) groups and the limited insight regarding the efficacy.

The aim of this randomized controlled trial is to improve birth outcomes and long-term outcomes in mother and child by optimizing lifestyle in the preconception period and early pregnancy in women and men. The main research question is whether an intervention focused on optimizing preconception and early pregnancy lifestyle, nutrition and stress improves the birth outcomes and long-term outcomes in mother and child?

This RCT will be embedded in the available Generation R Next research infrastructure.

Prior to randomization, the intervention and control groups will be offered an individual lifestyle consultation for both women and men, and, if pregnant, an early pregnancy ultrasound. After randomization, there will be two groups: the intervention group and the control group. Both groups will receive standard care, including an individual lifestyle consultation in line with current national standards for preconception and early pregnancy. The intervention group will additionally attend three group sessions (online and physical) focused on health during preconception and early pregnancy, coping with stress and adherence to a healthy lifestyle. The advices are based on national guidelines for health during the preconception period and early pregnancy. Compliance with the prescribed advice is encouraged via newly developed digital platform

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard care and additional lifestyle program

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

Group Type EXPERIMENTAL

Standard care

Intervention Type OTHER

Individual lifestyle consultation

Lifestyle program

Intervention Type 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

Individual consultation given at the research center by trained employees

Group Type OTHER

Standard care

Intervention Type OTHER

Individual lifestyle consultation

Interventions

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Standard care

Individual lifestyle consultation

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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