Clinical trial NCT05870878: Generation R Next - Optimaal Opgroeien
Official title: Generation R Next - Optimaal Opgroeien
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Early
Outcome, Adverse Birth
Lifestyle Factors
Preconception Care
Pregnancy Outcome
Pregnancy Complications
Risk Reduction Behavior
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: INDIGO Rijnmond
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Stichting Bevordering van Volkskracht
name: Stichting Achmea Gezondheidszor
name: Bernard van Leer Foundation
name: Ministerie van Volksgezondheid, Welzijn en Sport
First posted: 2023-05-23
Enrollment: 1750
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomisation with stratification factor: pregnancy status (yes/no)
Primary purpose: PREVENTION

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.

Detailed description: 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

Eligibility criteria: 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

Exclusion Criteria:

Women and their partners:

* Temporary or complete withdrawal from participation
* Gestational age \> 12+0 at study entry

Primary outcomes:
measure: Preterm birth
timeFrame: Assessed at birth
measure: Low birthweight/small-for-gestational-age
timeFrame: Assessed at birth
measure: High birthweight/large-for-gestational-age
timeFrame: Assessed at birth
measure: Low Apgar-score
timeFrame: Assessed at birth
measure: Birth weight
timeFrame: Assessed at birth
Secondary outcomes:
measure: Adherence to lifestyle advice (mother)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Sleep/wake rhythm (mother)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Sleep/wake rhythm (mother)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Social support (mother)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Experience of stress (mother)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Weight gain during pregnancy (mother)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Weight maintenance after 6 and 12 months pregnancy (mother)
timeFrame: 12 months after birth of the child
measure: Time to pregnancy (mother)
timeFrame: At delivery
measure: Occurrence of miscarriage (mother)
timeFrame: At delivery
measure: Glucose metabolism and diabetes during pregnancy (mother)
timeFrame: At delivery
measure: Occurrence of gestational hypertensive disorders during pregnancy (mother)
timeFrame: At delivery
measure: Adherence to lifestyle advice (partner)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Sleep/wake rhythm (partner)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Sleep/wake rhythm (partner)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Social support (partner)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Experience of stress (partner)
timeFrame: During pregnancy and early childhood, until 12 months
measure: Growth and adiposity (child)
timeFrame: 1, 3, 6 and 12 months of age
measure: Development and behavior (child)
timeFrame: 1, 3, 6 and 12 months of age
measure: Overall health (child)
timeFrame: 1, 6 and 12 months of age
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Vincent Jaddoe, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
References: