Lifestyle program to improve outcomes in dichorionic twin pregnancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Brugmann
  Brussels, Belgium Recruiting
• Ziekenhuis Oost-Limburg
  Genk, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Hôpital de la Citadelle
  Liège, Belgium Recruiting

Study contacts

• Study coordinator: Prof. Dr. Roland Devlieger
• Email: lifetwin@uzleuven.be
• Phone: +3216344200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.