[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539853":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":201,"collaborators":205,"id":214,"slug":215,"hasResults":216,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":216,"sex":222,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":25,"studyType":228,"phases":229,"briefSummary":231,"conditions":232,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Copenhagen University Hospital, Hvidovre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive weight loss intervention","EXPERIMENTAL","The intensive weight loss intervention (IWL) includes total dietary replacements, behavioural support, and weight loss medication. The intervention consists of three phases: induction, weight loss continuation, maintenance, and it will lasts two years in total.",[13],"Behavioral: Intensive weight loss intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Bariatric surgery","ACTIVE_COMPARATOR","Bariatric surgery: Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)",[19],"Procedure: Bariatric surgery",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"PROCEDURE","Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)",[15],[31],{"name":32,"affiliation":33,"role":34},"Carsten Dirksen, Ass Professor","Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Kirstine N Bojsen-Møller, MD, PhD","CONTACT","+45 3862 3862","kirstine.nyvold.bojsen-moeller@regionh.dk",{"name":42,"role":38,"phone":25,"phoneExt":25,"email":43},"Susan Jebb, Professor","lightbar@phc.ox.ac.uk",[45,61,73,85,97,112,124,136,144,152,164,169,177,189],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Steno Diabetes Center Aarhus, Aarhus Universitets Hospital","RECRUITING","Aarhus","8200","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],10.21076,56.15674,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":25,"phoneExt":25,"email":25},"Jens Bruun",{"facility":62,"status":47,"city":63,"state":25,"zip":64,"country":50,"countryCode":51,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"The Department of Medicine and Department of Surgery, University Hospital of South West Jutland","Esbjerg","6700",{"type":53,"coordinates":66},[67,68],8.45187,55.47028,{"lat":68,"lon":67},[71],{"name":72,"role":38,"phone":25,"phoneExt":25,"email":25},"Claus Borg Juhl",{"facility":74,"status":47,"city":75,"state":25,"zip":76,"country":50,"countryCode":51,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre","Hvidovre","2650",{"type":53,"coordinates":78},[79,80],12.47708,55.64297,{"lat":80,"lon":79},[83],{"name":84,"role":38,"phone":25,"phoneExt":25,"email":25},"Kirstine N Bojsen-Møller",{"facility":86,"status":47,"city":87,"state":25,"zip":88,"country":50,"countryCode":51,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Department of Surgery, Viborg Regional Hospital","Viborg","8800",{"type":53,"coordinates":90},[91,92],9.40201,56.45319,{"lat":92,"lon":91},[95],{"name":96,"role":38,"phone":25,"phoneExt":25,"email":25},"Peter Rask",{"facility":98,"status":47,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"St Richard's Hospital","Chichester","Sussex","PO19 6SE","United Kingdom","UK",{"type":53,"coordinates":105},[106,107],-0.78003,50.83673,{"lat":107,"lon":106},[110],{"name":111,"role":38,"phone":25,"phoneExt":25,"email":25},"Richard Newton",{"facility":113,"status":47,"city":114,"state":25,"zip":115,"country":102,"countryCode":103,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Hartlands Hospital, University Hospitals Birmingham NHS Foundation Trust","Birmingham","B9 5SS",{"type":53,"coordinates":117},[118,119],-1.89983,52.48142,{"lat":119,"lon":118},[122],{"name":123,"role":38,"phone":25,"phoneExt":25,"email":25},"Tom Wiggins",{"facility":125,"status":47,"city":126,"state":25,"zip":127,"country":102,"countryCode":103,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Southmead Hospital, North Bristol NHS Trust","Bristol","BS10 5NB",{"type":53,"coordinates":129},[130,131],-2.59665,51.45523,{"lat":131,"lon":130},[134],{"name":135,"role":38,"phone":25,"phoneExt":25,"email":25},"Dimitri Pournaras",{"facility":137,"status":47,"city":138,"state":25,"zip":25,"country":102,"countryCode":103,"cosmosGeoPoint":139,"geoPoint":143,"contacts":25},"University Hospital Coventry","Coventry",{"type":53,"coordinates":140},[141,142],-1.51217,52.40656,{"lat":142,"lon":141},{"facility":145,"status":47,"city":146,"state":25,"zip":25,"country":102,"countryCode":103,"cosmosGeoPoint":147,"geoPoint":151,"contacts":25},"Huddersfield Royal Infirmary","Huddersfield",{"type":53,"coordinates":148},[149,150],-1.78416,53.64904,{"lat":150,"lon":149},{"facility":153,"status":47,"city":154,"state":25,"zip":155,"country":102,"countryCode":103,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"The Whittington Hospital","London","N19 5NF",{"type":53,"coordinates":157},[158,159],-0.12574,51.50853,{"lat":159,"lon":158},[162],{"name":163,"role":38,"phone":25,"phoneExt":25,"email":25},"Chetan Parmer",{"facility":165,"status":47,"city":154,"state":25,"zip":25,"country":102,"countryCode":103,"cosmosGeoPoint":166,"geoPoint":168,"contacts":25},"King's College Hospital",{"type":53,"coordinates":167},[158,159],{"lat":159,"lon":158},{"facility":170,"status":47,"city":171,"state":25,"zip":25,"country":102,"countryCode":103,"cosmosGeoPoint":172,"geoPoint":176,"contacts":25},"Luton and Dunstable University Hospital","Luton",{"type":53,"coordinates":173},[174,175],-0.41748,51.87967,{"lat":175,"lon":174},{"facility":178,"status":47,"city":179,"state":25,"zip":180,"country":102,"countryCode":103,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Sunderland Royal Hospital","Sunderland","SR4 7TP",{"type":53,"coordinates":182},[183,184],-1.38222,54.90465,{"lat":184,"lon":183},[187],{"name":188,"role":38,"phone":25,"phoneExt":25,"email":25},"Aya Musbahi",{"facility":190,"status":47,"city":191,"state":25,"zip":192,"country":102,"countryCode":103,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Musgrove Park Hospital, Somerset Foundation NHS Trust","Taunton","TA1 5DA",{"type":53,"coordinates":194},[195,196],-3.10293,51.01494,{"lat":196,"lon":195},[199],{"name":200,"role":38,"phone":25,"phoneExt":25,"email":25},"Richard Welbourn",{"type":202,"investigatorFullName":203,"investigatorTitle":204,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Carsten Dirksen","Associate Professor",[206,208,210,212],{"name":207,"class":6},"University of Copenhagen",{"name":209,"class":6},"University of Southern Denmark",{"name":211,"class":6},"University of Oxford",{"name":213,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research","100539853","intensive-weight-loss-intervention-versus-bariatric-surgery-for-adults-with-severe-and-complex-obesity-the-lightbar-randomised-trial-100539853",false,"NCT06309238","Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial","Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 4","LightBAR","Please note that participants need to be invited in order to take part in the trial.\n\nInclusion Criteria:\n\n* Aged 18 to 60 years (inclusive) at time of screening.\n* Eligible for and willing to undergo bariatric surgery, i.e., fulfilment of criteria for bariatric surgery from the respective national health authorities:\n\n  * DK: BMI ≥ 35 kg\u002Fm2 with one or more of the following: T2D, severe hypertension, sleep apnoea requiring treatment, symptomatic arthrosis in lower extremities, female infertility related to overweight, or BMI\\>40 kg\u002Fm2 with other strong medical reasons for weight loss (28). Prior to surgery, an 8% weight loss is required as well as smoking cessation.\n  * UK: BMI of 35 kg\u002Fm2 to 40 kg\u002Fm2 and other significant disease (e.g., type 2 diabetes or high blood pressure), or BMI ≥40 kg\u002Fm2. Has been or is willing to receive intensive management in a specialist tier 3 obesity service (29).\n* Fit for anaesthesia and surgery.\n* Informed consent.\n\nExclusion Criteria:\n\n* Prior bariatric or hiatal surgery, not including intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \\>1 year before screening.\n* Use of any WLM (including liraglutide and semaglutide for diabetes) within last 3 months.\n* Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring basal bolus insulin therapy or insulin pump therapy (for Denmark) and any diabetes requiring insulin therapy (for UK), phenylketonuria, or other conditions requiring strict adherence to special diets).\n* Conditions that contraindicate or complicate treatment with GLP-1 receptor analogues (including history of pancreatitis or known allergies).\n* Conditions that contraindicate or complicate bariatric surgery (GI motility disorders, large abdominal wall hernia, large hiatus hernia (\\>5cm), Crohn's disease, liver cirrhosis, or other conditions preventing laparoscopic bariatric surgery e.g. multiple previous abdominal surgery).\n* Conditions that contraindicate or complicate study adherence and bariatric surgery (mental disorder, unstable psychiatric disease, recent history of alcohol\u002Fmedication abuse, cancer treatment within 5 years).\n* Pregnant or planning pregnancy in the next two years or currently breast feeding.\n* Not achieving a 5% weight loss within 12 weeks prior to randomisation.\n* People taking part in other research involving multidisciplinary obesity treatment that would compromise their participation in this trial.\n* Another member of the household enrolled in the trial.\n* Diagnosis of or treatment for severe eating disorder within the last 6 months.","ALL","18 Years","60 Years",{"count":226,"type":227},500,"ESTIMATED","INTERVENTIONAL",[230],"NA","With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option.",[233],"Obesity","2026-08-20",{"date":236,"type":237},"2026-08-21","ACTUAL",{"date":239,"type":237},"2024-05-08",{"date":241,"type":227},"2048-12",{"name":203,"class":6},14]