Lifestyle Intervention to Improve Twin Pregnancy Outcomes

Lifestyle Intervention to Improve Twin Pregnancy Outcomes: an Integrated Pilot Study for a Multicentric Randomized Controlled Trial

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.

For the pilot study, we aim to include 81 pregnant women across 4 sites. This sample size is based on pragmatic considerations, while ensuring diverse representation, including individuals from low socioeconomic status backgrounds and high-risk groups. For the full trial, in total 274 women are needed to detect a clinically meaningful difference in gestational age at delivery, the primary outcome.

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