NCT07270640 Lifestyle Intervention to Improve Twin Pregnancy Outcomes
| NCT ID | NCT07270640 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Twin Pregnancy, Dichorionic |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 81 participants in total. It began in 2025-12-05 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial to is assess the benefits of holistic lifestyle interventions, including nutrition, physical activities, and mindfulness, aiming to reduce preterm birth in twins, potentially revolutionizing twin care globally. An initial integrated pilot study is be conducted to assess and refine the intervention methods. The primary objective of the pilot study is to evaluate feasibility. If deemed feasible, the full study will be implemented, incorporating data from pilot study participants into the main study. Objective of the full study: To evaluate if a multi-component lifestyle extends gestational age at delivery by one week. Additional objective: to evaluate if the intervention positively influences multiple secondary outcomes including pregnancy complications, neonatal and maternal outcomes, and maternal quality of life.
Eligibility Criteria
Inclusion Criteria: * Prior to any randomization or intervention, participants must have provided voluntary written informed consent. * Diagnosis of dichorionic twin pregnancies must align with the acceptance criteria. * Participants must be recruited before the 14th week of gestation. * Proficiency in Dutch, English, or French is required.- Exclusion Criteria: * Participant has a history of pre-existing diseases or condition impacting their diet: 1. pre-gestational diabetes 2. severe heart disease, 3. chronic renal disease, 4. celiac disease, 5. inflammatory bowel disease, 6. post-bariatric surgery * Participant has a history of pre-existing diseases or conditions impacting their physical activity ability: 1. Chronic Obstructive Pulmonary Disease (COPD) 2. Severe Asthma. 3. Fibromyalgia 4. Osteoarthritis 5. Chronic Pain Syndromes 6. Spinal Cord Injuries. 7. Multiple Sclerosis (MS) 8. Parkinson's Disease 9. History of a Stroke 10. Drug resistance Epilepsy * Participants identified with mental vulnerabilities requiring specific care pathways by Born in Belgium (BIB) or local screening tool. * Participants with a History of Mental Health Disorders 1. Post-Traumatic Stress Disorder (PTSD) 2. Anxiety Disorders 3. Depressive Disorders 4. Bipolar Disorder 5. Obsessive-Compulsive Disorder (OCD) 6. Schizophrenia or schizoaffective disorder * Inability to give informed consent * No knowledge of Dutch, English or French * First trimester diagnosis of severe congenital anomaly in one or both twins * First trimester foetal demise of one or both twins * Rupture of membranes prior to recruitment * Participation in any other interventional Study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07270640 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Twin Pregnancy, Dichorionic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07270640 currently recruiting?
Yes, NCT07270640 is actively recruiting participants. Contact the research team at lifetwin@uzleuven.be for enrollment information.
Where is the NCT07270640 trial being conducted?
This trial is being conducted at Brussels, Belgium, Genk, Belgium, Leuven, Belgium, Liège, Belgium.
Who is sponsoring the NCT07270640 clinical trial?
NCT07270640 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 81 participants.