Lifestyle program to improve outcomes in dichorionic twin pregnancies
Lifestyle Intervention to Improve Twin Pregnancy Outcomes: an Integrated Pilot Study for a Multicentric Randomized Controlled Trial
This program will test whether a combined nutrition, exercise, and mindfulness plan for people pregnant with dichorionic twins can extend pregnancy and reduce preterm birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 4 sites (Brussels and 3 other locations) |
| Trial ID | NCT07270640 on ClinicalTrials.gov |
What this trial studies
This interventional project delivers a multi-component lifestyle program—nutrition guidance, tailored physical activity, and mindfulness—to people with dichorionic twin pregnancies recruited before 14 weeks' gestation. An initial integrated pilot phase will test feasibility and, if feasible, pilot participants will be rolled into the full study. The primary goal of the full study is to see if the intervention can extend gestational age at delivery by about one week, with secondary outcomes including pregnancy complications, maternal quality of life, and neonatal outcomes. Participants must be able to communicate in Dutch, English, or French and those with pre-existing conditions that limit diet or physical activity are excluded.
Who should consider this trial
Good fit: People pregnant with dichorionic twins enrolled before 14 weeks who speak Dutch, English, or French and do not have listed medical exclusions are the intended participants.
Not a fit: Those with pre-existing conditions that affect diet or physical activity (for example pre-gestational diabetes, severe heart or renal disease, celiac disease, COPD, severe asthma, neurological or musculoskeletal disorders) or those recruited after 14 weeks are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could prolong pregnancy by roughly one week and lower preterm birth rates, potentially improving neonatal health for twins.
How similar studies have performed: Lifestyle interventions have shown modest benefits in singleton pregnancies, but strong, replicated evidence in dichorionic twin pregnancies is limited, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels and 3 other locations
- CHU Brugmann — Brussels, Belgium (Not_yet_recruiting)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Hôpital de la Citadelle — Liège, Belgium (Not_yet_recruiting)
Study contacts
- Study coordinator: Prof. Dr. Roland Devlieger
- Email: lifetwin@uzleuven.be
- Phone: +3216344200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.