Lifestyle Intervention to Improve Twin Pregnancy Outcomes (LIFETWIN)

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Twin Pregnancy, Dichorionic

Treatments

Behavioral: LIFETWIN

Study type

Interventional

Funder types

Other

Identifiers

NCT07270640

S68251

Details and patient eligibility

About

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.

Enrollment

81 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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