protocolSection identificationModule nctId: NCT06321458, orgStudyIdInfo id: LightWAY, briefTitle: Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity, acronym: LightWAY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2048-12, studyFirstPostDateStruct date: 2024-03-20, 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: In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed.Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee 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., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Intensive weight loss intervention, interventions name: Usual care, outcomesModule primaryOutcomes measure: MetS-Z, primaryOutcomes measure: Weight, secondaryOutcomes measure: Short-Form-36, mental component score, secondaryOutcomes measure: Gait speed, secondaryOutcomes measure: Weight loss (20%), otherOutcomes measure: SAE, otherOutcomes measure: Incident eating disorders, otherOutcomes measure: Bone mineral density (BMD) assessed by DXA, otherOutcomes measure: Body composition - waist circumference, otherOutcomes measure: Body composition - fat percentage, otherOutcomes measure: Body composition - weight loss (10%), otherOutcomes measure: Physical functioning - SENS, otherOutcomes measure: Physical functioning - SF-36, otherOutcomes measure: Physical functioning - sit to stand test, otherOutcomes measure: Sleep, otherOutcomes measure: Medications during the intervention period, otherOutcomes measure: Metabolic health - blood pressure, otherOutcomes measure: Metabolic health - pulse, otherOutcomes measure: Metabolic health - Hb1Ac, otherOutcomes measure: Metabolic health - insulin, otherOutcomes measure: Metabolic health - HOMA2-IR, otherOutcomes measure: Metabolic health - lipids, otherOutcomes measure: Metabolic health - eGFR, otherOutcomes measure: Metabolic health - hsCRP, otherOutcomes measure: Metabolic health - Fib4, otherOutcomes measure: Metabolic health - proteinuria, otherOutcomes measure: Metabolic health - TSH, otherOutcomes measure: Mental health - MDI, otherOutcomes measure: Mental health - WBIS-M, otherOutcomes measure: Mental health - EDE-Q, otherOutcomes measure: Labour market attachment - WPAI, otherOutcomes measure: Labour market attachment - days of sick leave, otherOutcomes measure: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, index score, otherOutcomes measure: Health economy: Within-trial cost-effectiveness analysis - quality of life, VAS, 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 effects - incident cancer, otherOutcomes measure: Long-term effects - fracture risk, otherOutcomes measure: Long-term effects - health economic and labour market attachment, employment status, otherOutcomes measure: Long-term effects - health economic and labour market attachment, salary, otherOutcomes measure: Long-term effects - health economic and labour market attachment, absence, otherOutcomes measure: Long-term effects - health economic and labour market attachment, sick leave, otherOutcomes measure: Long-term effects - health economic and labour market attachment, long-term sick leave, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet, status: NOT_YET_RECRUITING, city: Frederiksberg, zip: 2000, country: Denmark, contacts name: Addie J Frederiksen, role: CONTACT, geoPoint lat: 55.67938, lon: 12.53463, locations facility: The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg, status: NOT_YET_RECRUITING, city: Frederiksberg, zip: 2000, country: Denmark, contacts name: Sofus C Larsen, role: CONTACT, geoPoint lat: 55.67938, lon: 12.53463, locations facility: Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse, status: NOT_YET_RECRUITING, city: Hvidovre, zip: 2650, country: Denmark, contacts name: Maria Bleiback Clausen, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, 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: Carsten Dirksen, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, locations facility: Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering, status: NOT_YET_RECRUITING, city: Søborg, zip: 2860, country: Denmark, contacts name: Julie Borgen Braget, role: CONTACT, geoPoint lat: 56.08481, lon: 12.31803, locations facility: IHR CRN: Thames Valley and South Midlands, status: NOT_YET_RECRUITING, city: Oxford, country: United Kingdom, contacts name: Susan Jebb, role: CONTACT, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False