Lifestyle Intervention to Improve Twin Pregnancy Outcomes

Recruiting now · Not applicable

Conditions studied: Twin Pregnancy, Dichorionic

In brief

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.

Key facts

Study ID

NCT07270640

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

81

Starts

2025-12-05

Expected to finish

2027-06-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.-

You may not qualify if…

• Participant has a history of pre-existing diseases or condition impacting their diet:
• pre-gestational diabetes
• severe heart disease,
• chronic renal disease,
• celiac disease,
• inflammatory bowel disease,
• post-bariatric surgery
• Participant has a history of pre-existing diseases or conditions impacting their physical activity ability:
• Chronic Obstructive Pulmonary Disease (COPD)
• Severe Asthma.
• Fibromyalgia
• Osteoarthritis
• Chronic Pain Syndromes
• Spinal Cord Injuries.
• Multiple Sclerosis (MS)
• Parkinson's Disease
• History of a Stroke
• 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
• Post-Traumatic Stress Disorder (PTSD)
• Anxiety Disorders
• Depressive Disorders
• Bipolar Disorder
• Obsessive-Compulsive Disorder (OCD)

Where it is running

• CHU Brugmann — Brussels, Belgium (enrolling)
• Ziekenhuis Oost-Limburg — Genk, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Hôpital de la Citadelle — Liège, Belgium (enrolling)

Full record on ClinicalTrials.gov

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