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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Lifestyle coaching sessions |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIFETWIN | Behavioral | The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction. |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational age at delivery (main) | The primary outcome is gestational age at delivery, measured in weeks and days. This is calculated based on the last menstrual period and confirmed via early ultrasound dating (before 13 weeks and 6 days) for spontaneous pregnancies or based on embryo age at transfer for IVF patients. The study aims to evaluate whether a multi-component lifestyle intervention can delay delivery by at least one week, thereby enhancing pregnancy outcomes. Gestational age data will be collected from medical records to ensure accuracy and consistency. | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight (main) | Birth weight in grams and percentile. | Delivery |
| Small for gestational age (main) | Small for gestational age in at least one twin, defined as below the 10th percentile according to twins' nomograms |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal mortality (main) | Maternal mortality- defined as death of the mother during pregnancy or within 42 days postpartum, due to any cause related to or aggravated by pregnancy or its management. | within 42 days postpartum |
| Caesarean section delivery (main) |
Inclusion Criteria:
Exclusion Criteria:
Participant has a history of pre-existing diseases or condition impacting their diet:
Participant has a history of pre-existing diseases or conditions impacting their physical activity ability:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Roland Devlieger | Contact | +3216344200 | lifetwin@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brugmann | Recruiting | Brussels | 1020 | Belgium |
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First, a pilot phase (n = 81) is installed to evaluate feasibility. After evaluation and if necessary protocol amendments, a full trial will be rolled out (n = 274)
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| Delivery |
| Offspring mortality (main) | Offspring mortality- defined as the death of one or both twins occurring at any time from foetal viability (24 weeks' gestation) until 28 days postpartum (neonatal period). | 24 weeks -28 days postpartum |
| Offspring infection (main) | Offspring infection- defined as neonatal sepsis, congenital pneumonia, neonatal meningitis, or necrotizing enterocolitis (NEC) with infection within the first 72 hours of delivery. | within the first 72 hours of delivery |
| Early neurodevelopmental morbidity (main) | Early neurodevelopmental morbidity- defined as diagnosis of Intraventricular haemorrhage (IVH) Grade III-IV, periventricular leukomalacia (PVL), hypoxic-ischemic encephalopathy (HIE), and neonatal seizures. | 6 weeks postpartum |
| Gastrointestinal morbidity (main) | Gastrointestinal morbidity- defined as diagnosis of NEC and spontaneous perforation. | 6 weeks postpartum |
| Respiratory morbidity (main) | Respiratory morbidity- defined as diagnosis of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), transient tachypnoea of the newborn (TTN) or persistent pulmonary hypertension of the newborn (PPHN) | 6 weeks postpartum |
| NICU admission (main) | Any admission to the Neonatal intensive care unit (NICU) within 72 hours of delivery. | within 72 hours of delivery |
| Number of days in the NICU (main) | Number of days in the NICU | 6 weeks postpartum |
| Gestational weight gain (main) | Gestational Weight Gain (GWG) corrected to pregnancy duration. | from 14 weeks pregnancy to delivery |
| Maternal quality of life (main) | Maternal quality of Life based on questionnaire EQ-5D-5L. | Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum |
| Postpartum weight (main) | Postpartum weight recorded 6 weeks postpartum | 6 weeks postpartum |
| delivery |
| Premature rupture of the membranes (main) | before week 34 |
| Maternal number of days in hospitalization after delivery (main) | 6 weeks postpartum |
| Maternal pregnancy related hypertension (main) | Maternal pregnancy related hypertension- defines as Pregnancy-induced hypertension or preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP). | from 14 weeks of pregnancy to delivery |
| Maternal gestational diabetes mellitus (main) | Maternal gestational diabetes mellitus as defined by diagnosis of diabetes after week 20 in a two-step approach according to the Carpenter/Coustan criteria. | from week 20 of pregnancy to delivery |
| maternal anaemia (main) | Maternal anaemia defined by haemoglobin under 10 g/dL during pregnancy. | from 14 weeks of pregnancy to delivery |
| Food consumption change (main) | Food consumption change based on 32-item semi-quantitative Food Frequency Questionnaire | before 14 weeks, 32-34 weeks of pregnancy and 6 weeks postpartum |
| Physical activity (main) | Physical activity level based on the Kaiser Physical Activity Survey. | before 14 weeks, 32-34 weeks, 6 weeks postpartum |
| Change in lifestyle habits (main) | Change in lifestyle habits based on Lifestyle behaviour questionnaire. | before 14 weeks, 32-34 weeks, 6 weeks postpartum |
| Neonatal number of days in hospitalization after delivery (main) | 6 weeks after birth |
| Number of recruited participants (pilot) | Recruitment Success (RE-AIM Principle: Reach and Adoption): assessment the ability to recruit participants over the course of the pilot. Recruitment efforts will focus on engaging a diverse demographic, particularly including women from low SES and high-risk backgrounds. | through pilot study completion, an average of 1.5 years |
| Training and retention of study midwifes (pilot) | Midwife Engagement (RE-AIM Principle: Adoption): Midwives at all centres will undergo a two-day training program tailored to the LIFETWIN intervention. Retention and engagement of midwives will be monitored throughout the pilot study. | through pilot study completion, an average of 1.5 years |
| Consistency of intervention delivery (pilot) | Intervention Fidelity (RE-AIM Principle: Implementation): We will assess how consistently the intervention (8 lifestyle sessions) can be delivered during the pilot study, both face-to-face and remotely, ensuring quality and adherence across all pilot centres. | through pilot study completion, an average of 1.5 years |
| The number of participants retained throughout the pilot study (pilot) | Participant Retention (RE-AIM Principle: Maintenance): Monitor retention rates of participants throughout the pilot study period, with reasons for lack of adherence and dropout carefully recorded. This will help us understand both the feasibility of maintaining participant engagement and the practical challenges in long-term implementation | through pilot study completion, an average of 1.5 years |
| Qualitative feedback on experiences with the intervention (pilot) | Qualitative Feedback (RE-AIM Principle: Maintenance): Midwives and participants will be interviewed during/after the pilot phase, to assess how the intervention is perceived, experienced, and sustained over time. Insights from this feedback will be critical for informing the next phase of the study (i.e. the main trial), especially regarding long-term adoption and sustainability. | through pilot study completion, an average of 1.5 years |
| Ziekenhuis Oost-Limburg | Recruiting | Genk | 3600 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
|
| Hôpital de la Citadelle | Recruiting | Liège | 4000 | Belgium |
|