protocolSection identificationModule nctId: NCT06309238, orgStudyIdInfo id: LightBAR, briefTitle: Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial, acronym: LightBAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2048-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Carsten Dirksen, class: OTHER, collaborators name: University of Copenhagen, collaborators name: University of Southern Denmark, collaborators name: University of Oxford, collaborators name: University of Bristol, collaborators name: Copenhagen Trial Unit, Center for Clinical Intervention Research, descriptionModule briefSummary: 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., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions.Blinded outcome assessment will be employed for the primary outcome and anywhere else possible. When assessing clinical outcomes, the participants will be asked not to disclose their assigned intervention group to the outcome assessor. Further, they will be provided with a plain white t-shirt, or similar, to wear during clinical assessments to cover the presence of surgical scars.Statisticians and investigators drawing conclusions will be fully blinded. We will conduct the statistical analyses with the intervention groups coded as e.g., 'A' and 'B'. We will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Intensive weight loss intervention, interventions name: Bariatric surgery, outcomesModule primaryOutcomes measure: MetS-Z, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Gait speed, secondaryOutcomes measure: Short-Form-36, mental component score, otherOutcomes measure: SAE, otherOutcomes measure: Proportion of participants with at least one adverse events (AE) of special interest. Each of the AE will also be assessed individually exploratorily., otherOutcomes measure: Cardiometabolic health - metabolic syndrome, otherOutcomes measure: Cardiometabolic health - blood pressure, otherOutcomes measure: Cardiometabolic health - pulse, otherOutcomes measure: Cardiometabolic health - glucose, otherOutcomes measure: Cardiometabolic health - Hb1Ac, otherOutcomes measure: Cardiometabolic health - insulin, otherOutcomes measure: Cardiometabolic health - HOMA2-IR, otherOutcomes measure: Cardiometabolic health - lipids, otherOutcomes measure: Cardiometabolic health - eGFR, otherOutcomes measure: Cardiometabolic health - hsCRP, otherOutcomes measure: Cardiometabolic health - Fib-4, otherOutcomes measure: Cardiometabolic health - proteinuria, otherOutcomes measure: Cardiometabolic health - TSH, otherOutcomes measure: Weight and body composition - weight loss, otherOutcomes measure: Weight and body composition - waist circumference, otherOutcomes measure: Weight and body composition - body fat and lean body mass, otherOutcomes measure: Physical functioning - sedentary and active, otherOutcomes measure: Physical functioning - sit to stand test, otherOutcomes measure: Medication use, otherOutcomes measure: Micronutrient status, assessed as proportion of participants with deficiency, otherOutcomes measure: Bone mineral density (BMD) assessed by DXA, otherOutcomes measure: Sleep - ESS, otherOutcomes measure: Sleep - sleep and wake time, otherOutcomes measure: Sleep - sleep movement, otherOutcomes measure: Health-related quality of life and mental health - EQ-5D-5L, index score, otherOutcomes measure: Health-related quality of life and mental health - EQ-5D-5L, VAS, otherOutcomes measure: Health-related quality of life and mental health - SF-36, otherOutcomes measure: Health-related quality of life and mental health - EDE-Q, otherOutcomes measure: Health-related quality of life and mental health - WBIS-M, otherOutcomes measure: Health-related quality of life and mental health - MDI, otherOutcomes measure: Labour market attachment - WPAI, otherOutcomes measure: Labour market attachment - days of sick leave, otherOutcomes measure: Continuous glucose monitoring - hypoglycaemic range, otherOutcomes measure: Continuous glucose monitoring - hypoglycaemic events, otherOutcomes measure: Continuous glucose monitoring - glucose variability, otherOutcomes measure: Continuous glucose monitoring - hypoglycaemic symptoms, otherOutcomes measure: Pending additional funding: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs bariatric surgery, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - costs, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - QALY, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - healthcare costs, otherOutcomes measure: Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios, otherOutcomes measure: Long-term effects - mortality and major cardiovascular disease (CVD), otherOutcomes measure: Long-term effects - prescription patterns, otherOutcomes measure: Long-term effect - incident cancer, otherOutcomes measure: Long-term effect - surgical procedures, otherOutcomes measure: Long-term effect - fracture risk, otherOutcomes measure: Long-term effect - health economic and labour market attachment, employment status, otherOutcomes measure: Long-term effect - health economic and labour market attachment, salary, otherOutcomes measure: Long-term effect - health economic and labour market attachment, absence, otherOutcomes measure: Long-term effect - health economic and labour market attachment, sick leave, otherOutcomes measure: Long-term effect - health economic and labour market attachment, long-term sick leave, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Steno Diabetes Center Aarhus, Aarhus Universitets Hospital, status: NOT_YET_RECRUITING, city: Aarhus, zip: 8200, country: Denmark, contacts name: Jens Bruun, role: CONTACT, geoPoint lat: 56.15674, lon: 10.21076, locations facility: The Department of Medicine and Department of Surgery, University Hospital of South West Jutland, status: NOT_YET_RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, contacts name: Claus Borg Juhl, role: CONTACT, geoPoint lat: 55.47028, lon: 8.45187, locations facility: The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre, status: RECRUITING, city: Hvidovre, zip: 2650, country: Denmark, contacts name: Kirstine N Bojsen-Møller, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, locations facility: The Department of Medicine and the Department of Surgery, Zealand University Hospital Køge, status: NOT_YET_RECRUITING, city: Køge, zip: 4600, country: Denmark, contacts name: Merethe Hansen, role: CONTACT, geoPoint lat: 55.45802, lon: 12.18214, locations facility: Department of Surgery, Viborg Regional Hospital, status: NOT_YET_RECRUITING, city: Viborg, zip: 8800, country: Denmark, contacts name: Peter Rask, role: CONTACT, geoPoint lat: 56.45319, lon: 9.40201, locations facility: Southmead Hospital, North Bristol NHS Trust, status: NOT_YET_RECRUITING, city: Bristol, zip: BS10 5NB, country: United Kingdom, contacts name: Dimitri Pournaras, role: CONTACT, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Southampton, zip: SO16 6YD, country: United Kingdom, contacts name: James Byrne, role: CONTACT, geoPoint lat: 50.90395, lon: -1.40428, locations facility: Musgrove Park Hospital, Somerset Foundation NHS Trust, status: NOT_YET_RECRUITING, city: Taunton, zip: TA1 5DA, country: United Kingdom, contacts name: Richard Welbourn, role: CONTACT, geoPoint lat: 51.01494, lon: -3.10293, hasResults: False