[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613749":3},{"organization":4,"outcomesModule":7,"designInfo":111,"detailedDescription":63,"studyPopulation":63,"armGroups":118,"interventions":129,"overallOfficials":63,"centralContacts":135,"locations":141,"responsibleParty":200,"collaborators":63,"id":202,"slug":63,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":132,"eligibilityCriteria":207,"healthyVolunteers":203,"sex":208,"minAge":209,"maxAge":63,"enrollmentInfo":210,"targetDuration":63,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":144,"whyStopped":63,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20,24,28,32,35,38,42,45,49,53],{"measure":15,"description":16,"timeFrame":12},"Birth weight (main)","Birth weight in grams and percentile.",{"measure":18,"description":19,"timeFrame":12},"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":21,"description":22,"timeFrame":23},"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",{"measure":25,"description":26,"timeFrame":27},"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",{"measure":29,"description":30,"timeFrame":31},"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",{"measure":33,"description":34,"timeFrame":31},"Gastrointestinal morbidity (main)","Gastrointestinal morbidity- defined as diagnosis of NEC and spontaneous perforation.",{"measure":36,"description":37,"timeFrame":31},"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)",{"measure":39,"description":40,"timeFrame":41},"NICU admission (main)","Any admission to the Neonatal intensive care unit (NICU) within 72 hours of delivery.","within 72 hours of delivery",{"measure":43,"description":44,"timeFrame":31},"Number of days in the NICU (main)","Number of days in the NICU",{"measure":46,"description":47,"timeFrame":48},"Gestational weight gain (main)","Gestational Weight Gain (GWG) corrected to pregnancy duration.","from 14 weeks pregnancy to delivery",{"measure":50,"description":51,"timeFrame":52},"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",{"measure":54,"description":55,"timeFrame":31},"Postpartum weight (main)","Postpartum weight recorded 6 weeks postpartum",[57,61,65,68,70,74,78,81,85,89,92,95,99,102,105,108],{"measure":58,"description":59,"timeFrame":60},"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",{"measure":62,"description":63,"timeFrame":64},"Caesarean section delivery (main)",null,"delivery",{"measure":66,"description":63,"timeFrame":67},"Premature rupture of the membranes (main)","before week 34",{"measure":69,"description":63,"timeFrame":31},"Maternal number of days in hospitalization after delivery (main)",{"measure":71,"description":72,"timeFrame":73},"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",{"measure":75,"description":76,"timeFrame":77},"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\u002FCoustan criteria.","from week 20 of pregnancy to delivery",{"measure":79,"description":80,"timeFrame":73},"maternal anaemia (main)","Maternal anaemia defined by haemoglobin under 10 g\u002FdL during pregnancy.",{"measure":82,"description":83,"timeFrame":84},"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",{"measure":86,"description":87,"timeFrame":88},"Physical activity (main)","Physical activity level based on the Kaiser Physical Activity Survey.","before 14 weeks, 32-34 weeks, 6 weeks postpartum",{"measure":90,"description":91,"timeFrame":88},"Change in lifestyle habits (main)","Change in lifestyle habits based on Lifestyle behaviour questionnaire.",{"measure":93,"description":63,"timeFrame":94},"Neonatal number of days in hospitalization after delivery (main)","6 weeks after birth",{"measure":96,"description":97,"timeFrame":98},"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",{"measure":100,"description":101,"timeFrame":98},"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.",{"measure":103,"description":104,"timeFrame":98},"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.",{"measure":106,"description":107,"timeFrame":98},"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",{"measure":109,"description":110,"timeFrame":98},"Qualitative feedback on experiences with the intervention (pilot)","Qualitative Feedback (RE-AIM Principle: Maintenance): Midwives and participants will be interviewed during\u002Fafter 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.",{"allocation":112,"interventionModel":113,"interventionModelDescription":114,"primaryPurpose":115,"observationalModel":63,"timePerspective":63,"maskingInfo":116},"RANDOMIZED","PARALLEL","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)","PREVENTION",{"masking":117,"maskingDescription":63,"whoMasked":63},"NONE",[119,125],{"label":120,"type":121,"description":122,"interventionNames":123},"Intervention","EXPERIMENTAL","Lifestyle coaching sessions",[124],"Behavioral: LIFETWIN",{"label":126,"type":127,"description":128,"interventionNames":63},"Control","NO_INTERVENTION","Standard of care",[130],{"type":131,"name":132,"description":133,"armGroupLabels":134,"otherNames":63},"BEHAVIORAL","LIFETWIN","The LIFETWIN intervention provides 8 coaching sessions to women during pregnancy, focusing on nutrition (including multivitamin intake), physical activity and stress reduction.",[120],[136],{"name":137,"role":138,"phone":139,"phoneExt":63,"email":140},"Prof. Dr. Roland Devlieger","CONTACT","+3216344200","lifetwin@uzleuven.be",[142,160,174,187],{"facility":143,"status":144,"city":145,"state":63,"zip":146,"country":147,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":154,"contacts":155},"CHU Brugmann","RECRUITING","Brussels","1020","Belgium","BE",{"type":150,"coordinates":151},"Point",[152,153],4.34878,50.85045,{"lat":153,"lon":152},[156,158],{"name":157,"role":138,"phone":139,"phoneExt":63,"email":140},"Jacques Jani, MD, PhD",{"name":157,"role":159,"phone":63,"phoneExt":63,"email":63},"PRINCIPAL_INVESTIGATOR",{"facility":161,"status":144,"city":162,"state":63,"zip":163,"country":147,"countryCode":148,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Ziekenhuis Oost-Limburg","Genk","3600",{"type":150,"coordinates":165},[166,167],5.50082,50.965,{"lat":167,"lon":166},[170,172],{"name":171,"role":138,"phone":139,"phoneExt":63,"email":140},"Dr. Tinne Mesens",{"name":173,"role":159,"phone":63,"phoneExt":63,"email":63},"Tinne Mesens, MD",{"facility":175,"status":144,"city":176,"state":63,"zip":177,"country":147,"countryCode":148,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"UZ Leuven","Leuven","3000",{"type":150,"coordinates":179},[180,181],4.70093,50.87959,{"lat":181,"lon":180},[184,185],{"name":137,"role":138,"phone":139,"phoneExt":63,"email":140},{"name":186,"role":159,"phone":63,"phoneExt":63,"email":63},"Roland Devlieger, MD, PhD",{"facility":188,"status":144,"city":189,"state":63,"zip":190,"country":147,"countryCode":148,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Hôpital de la Citadelle","Liège","4000",{"type":150,"coordinates":192},[193,194],5.56749,50.63373,{"lat":194,"lon":193},[197,199],{"name":198,"role":138,"phone":139,"phoneExt":63,"email":140},"Laure Noël, MD",{"name":198,"role":159,"phone":63,"phoneExt":63,"email":63},{"type":201,"investigatorFullName":63,"investigatorTitle":63,"investigatorAffiliation":63,"oldNameTitle":63,"oldOrganization":63},"SPONSOR","100613749",false,"NCT07270640","Lifestyle Intervention to Improve Twin Pregnancy Outcomes","Lifestyle Intervention to Improve Twin Pregnancy Outcomes: an Integrated Pilot Study for a Multicentric Randomized Controlled Trial","Inclusion Criteria:\n\n* Prior to any randomization or intervention, participants must have provided voluntary written informed consent.\n* Diagnosis of dichorionic twin pregnancies must align with the acceptance criteria.\n* Participants must be recruited before the 14th week of gestation.\n* Proficiency in Dutch, English, or French is required.-\n\nExclusion Criteria:\n\n* Participant has a history of pre-existing diseases or condition impacting their diet:\n\n  1. pre-gestational diabetes\n  2. severe heart disease,\n  3. chronic renal disease,\n  4. celiac disease,\n  5. inflammatory bowel disease,\n  6. post-bariatric surgery\n* Participant has a history of pre-existing diseases or conditions impacting their physical activity ability:\n\n  1. Chronic Obstructive Pulmonary Disease (COPD)\n  2. Severe Asthma.\n  3. Fibromyalgia\n  4. Osteoarthritis\n  5. Chronic Pain Syndromes\n  6. Spinal Cord Injuries.\n  7. Multiple Sclerosis (MS)\n  8. Parkinson's Disease\n  9. History of a Stroke\n  10. Drug resistance Epilepsy\n* Participants identified with mental vulnerabilities requiring specific care pathways by Born in Belgium (BIB) or local screening tool.\n* Participants with a History of Mental Health Disorders\n\n  1. Post-Traumatic Stress Disorder (PTSD)\n  2. Anxiety Disorders\n  3. Depressive Disorders\n  4. Bipolar Disorder\n  5. Obsessive-Compulsive Disorder (OCD)\n  6. Schizophrenia or schizoaffective disorder\n* Inability to give informed consent\n* No knowledge of Dutch, English or French\n* First trimester diagnosis of severe congenital anomaly in one or both twins\n* First trimester foetal demise of one or both twins\n* Rupture of membranes prior to recruitment\n* Participation in any other interventional Study","FEMALE","18 Years",{"count":211,"type":212},81,"ESTIMATED","INTERVENTIONAL",[215],"NA","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.\n\nAn 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.\n\nObjective 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.",[218],"Twin Pregnancy, Dichorionic",[220,221,222],"twin pregnancy","dichorionic","lifestyle interventions","2026-06-23",{"date":225,"type":226},"2026-06-26","ACTUAL",{"date":228,"type":226},"2025-12-05",{"date":230,"type":212},"2027-06",{"name":5,"class":6},4]