Actively Recruiting
Generation R Next - Optimizing Lifestyle for Healthy Pregnancy and Birth Outcomes
Led by Erasmus Medical Center · Updated on 2024-09-04
1750
Participants Needed
1
Research Sites
235 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
This research aims to improve birth and long-term outcomes for mothers and children by focusing on lifestyle, nutrition, and stress management during the preconception period and early pregnancy. The trial evaluates whether an intervention that optimizes these factors in both women and their partners can lead to better health outcomes. It is a randomized controlled trial embedded within the Generation R Next research infrastructure. Participants first receive an individual lifestyle consultation. Then, depending on the study group, they either receive standard care alone or standard care plus a lifestyle program. The lifestyle program includes three group sessions (one physical and two online) and access to a digital platform, focusing on healthy weight, stopping harmful habits, proper supplementation, a balanced diet, and stress reduction through mind-body therapies like yoga and mindfulness. Throughout the study, researchers will monitor birth outcomes such as preterm birth, birth weight, and Apgar scores. They will also assess adherence to lifestyle advice, sleep patterns, stress experience, social support, pregnancy weight changes, and child development up to 12 months after birth. Participants are encouraged to follow the lifestyle recommendations, and the study follows them from preconception or early pregnancy until one year after childbirth.
CONDITIONS
Brief Title
Generation R Next - Optimaal Opgroeien
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 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 childbirth
- Consent to participate in the study
You will not qualify if you...
- Temporary or complete withdrawal from participation
- Gestational age greater than 12 weeks at study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks (preconception or early pregnancy)
Participants receive an individual lifestyle consultation and, if pregnant, an early pregnancy ultrasound before randomization.
1 visit (in-person)
Duration - From preconception or early pregnancy until birth
Participants receive standard care including individual lifestyle consultations. Those in the intervention group attend three group lifestyle sessions (online and physical) and use an online platform focusing on healthy lifestyle, stress coping, and nutrition during preconception and early pregnancy.
3 group sessions (1 physical and 2 online) plus individual consultations
Duration - Up to 12 months after birth
Participants and their children are monitored for adherence to lifestyle advice, health outcomes, and development up to 12 months after birth.
Assessments at 1, 3, 6, and 12 months after birth
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, Netherlands, 3015CN
Actively Recruiting
Research Team
V
Vincent Jaddoe, Dr,.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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