Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT06321432
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2024-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "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.\n\nStatisticians 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 ill 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', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2048-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety - SAE', 'timeFrame': '104 weeks after randomisation', 'description': 'Proportion of participants that experienced at least one serious adverse event (according to ICH-GCP guidelines)'}, {'measure': 'Safety - eating disorder', 'timeFrame': '104 weeks after randomisation', 'description': 'Proportion of participants with incident eating disorders during the intervention period'}, {'measure': 'Safety - bone mineral density (BMD) assessed by DXA', 'timeFrame': '104 weeks after randomisation', 'description': '1. Bone mineral density (g/cm²) of hip (total hip and femoral neck).\n2. Bone mineral density (g/cm²) of lumbar region.'}, {'measure': 'Body composition - waist circumference', 'timeFrame': '104 weeks after randomisation', 'description': 'Waist circumference (cm)'}, {'measure': 'Body composition - fat percentage', 'timeFrame': '104 weeks after randomisation', 'description': '* Body fat percentage\n* Visceral fat percentage\n* Subcutaneous fat percentage'}, {'measure': 'Body composition - weight loss (10%)', 'timeFrame': '104 weeks after randomisation', 'description': 'Proportion of participants with weight loss ≥10%'}, {'measure': 'Physical functioning - SENS', 'timeFrame': '104 weeks after randomisation', 'description': 'Objectively measured moderate to vigorous physical activity (MVPA) using SENS Motion accelerometers (hours/day)'}, {'measure': 'Physical functioning - SF-36', 'timeFrame': '104 weeks after randomisation', 'description': 'Short Form 36 (SF-36) physical component score (scale from 0-100, higher scores indicate better physical health)'}, {'measure': 'Physical functioning - sit to stand test', 'timeFrame': '104 weeks after randomisation', 'description': 'Number of sit to stands completed 30 Second Sit to Stand test'}, {'measure': 'Physical functioning - quality of life', 'timeFrame': '104 weeks after randomisation', 'description': 'EQ-5D-5L (the 5-level EQ-5D version), index score (score between -1 and 1, higher scores indicate better health)'}, {'measure': 'Sleep', 'timeFrame': '104 weeks after randomisation', 'description': 'Sleep duration using SENS Motion accelerometers (hours/day)'}, {'measure': 'Medications during the intervention period', 'timeFrame': '104 weeks after randomisation', 'description': '1. Proportion of participants prescribed glucose-lowering medications during the intervention period (number, type)\n2. Proportion of participants prescribed lipid-lowering medications during the intervention period (number, type)\n3. Proportion of participants prescribed blood pressure-lowering medications during the intervention period (number, type)\n4. Proportion of participants prescribed medication for pain relief during the intervention period (number, type)\n5. Proportion of participants prescribed medications for psychiatric disorders (number, type)'}, {'measure': 'Metabolic health - blood pressure', 'timeFrame': '104 weeks after randomisation', 'description': 'Systolic and diastolic blood pressure (mmHg)'}, {'measure': 'Metabolic health - pulse', 'timeFrame': '104 weeks after randomisation', 'description': 'Pulse rate (beats per minute)'}, {'measure': 'Metabolic health - glucose', 'timeFrame': '104 weeks after randomisation', 'description': 'Fasting glucose concentration (mmol/l)'}, {'measure': 'Metabolic health - Hb1Ac', 'timeFrame': '104 weeks after randomisation', 'description': 'Haemoglobin A1c (mmol/mol)'}, {'measure': 'Metabolic health - insulin', 'timeFrame': '104 weeks after randomisation', 'description': 'Fasting insulin concentration (pmol/L)'}, {'measure': 'Metabolic health - HOMA2-IR', 'timeFrame': '104 weeks after randomisation', 'description': 'HOMA2-IR (calculated from glucose and C-peptide concentration) (ratio)'}, {'measure': 'Metabolic health - lipids', 'timeFrame': '104 weeks after randomisation', 'description': 'Fasting lipid profile (HDL, LDL and triglycerides) (mmol/L)'}, {'measure': 'Metabolic health - eGFR', 'timeFrame': '104 weeks after randomisation', 'description': 'Estimated Glomerular Filtration Rate (eGFR), creatinine (µmol/L), calculated from creatinine, sex and years'}, {'measure': 'Metabolic health - hsCRP', 'timeFrame': '104 weeks after randomisation', 'description': 'High-sensitivity C-reactive protein (hsCRP), mg/L'}, {'measure': 'Metabolic health - Fib4', 'timeFrame': '104 weeks after randomisation', 'description': 'Fib-4 (ALT/AST/platelets) (ratio)'}, {'measure': 'Metabolic health - Proteinuria', 'timeFrame': '104 weeks after randomisation', 'description': 'Proteinuria, measured as urine albumin/creatinine (ratio)'}, {'measure': 'Metabolic health - TSH', 'timeFrame': '104 weeks after randomisation', 'description': 'Thyroid-stimulating hormone (IU/L)'}, {'measure': 'Mental health - MDI', 'timeFrame': '104 weeks after randomisation', 'description': 'Major Depression Inventory (MDI) (scale from 0-50, higher scores indicate more symptoms of depression)'}, {'measure': 'Mental health - WBIS-M', 'timeFrame': '104 weeks after randomisation', 'description': 'Weight Bias Internalization Scale (WBIS-M) score (scale from 1-7, higher scores indicate higher degree of internalised weight bias)'}, {'measure': 'Mental health - EDE-Q', 'timeFrame': '104 weeks after randomisation', 'description': 'Eating Disorder Examination Questionnaire (EDE-Q) score (scale from 0 to 6, higher scores indicate higher degree of eating disorder)'}, {'measure': 'Labour market attachment - WPAI', 'timeFrame': '104 weeks after randomisation', 'description': 'Work productivity and impairment (WPAI) score points (scale from 0-100, higher scores indicate more limitations in ability to work and lower productivity)'}, {'measure': 'Labour market attachment - days of sick leave', 'timeFrame': '104 weeks after randomisation', 'description': 'Self-reported number of days sick leave during follow-up'}, {'measure': "Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care", 'timeFrame': '104 weeks after randomisation', 'description': '1. Common gene variants with low to moderate effect on the phenotype for the construction of aggregate genetic risk scores\n2. Rare variants with potential functional effects in genes known to harbour high-impact obesity variants e.g. MC4R, LEP, LEPR, POMC, PCSK1, SIM1, NTRK2, MC3R, MRAP2, BDNF, SH2B1, KSR2'}, {'measure': 'Health economy: Within-trial cost-effectiveness analysis - quality of life', 'timeFrame': '104 weeks after randomisation', 'description': 'Quality of life (measured using the 5-level EQ-5D version (EQ-5D-5L), VAS score (scale from 0-100, higher scores indicate better health)'}, {'measure': 'Health economy: Within-trial cost-effectiveness analysis - costs', 'timeFrame': '104 weeks after randomisation', 'description': '24-month costs, DKK'}, {'measure': 'Health economy: Within-trial cost-effectiveness analysis - QALY', 'timeFrame': '104 weeks after randomisation', 'description': 'Incremental cost per quality-adjusted-life-year (QALY) gained, DKK'}, {'measure': 'Health economy: Model-based cost-effectiveness analysis - QALY', 'timeFrame': '104 weeks after randomisation', 'description': 'Predicted lifetime QALYs gained'}, {'measure': 'Health economy: Model-based cost-effectiveness analysis - healthcare costs', 'timeFrame': '104 weeks after randomisation', 'description': 'Predicted lifetime healthcare costs, DKK'}, {'measure': 'Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios', 'timeFrame': '104 weeks after randomisation', 'description': 'Long-term incremental cost effectiveness ratios'}, {'measure': 'Long-term effects - mortality and major cardiovascular disease (CVD)', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': '* Proportion of participants who die from any cause\n* Proportion of participants with a major CVD outcome consisting of any of the following (each of the components will be assessed exploratively): myocardial infarction, stroke, hospitalisation for angina, coronary-artery bypass grafting, percutaneous coronary intervention, hospitalisation for heart failure, peripheral vascular disease'}, {'measure': 'Long-term effects - prescription patterns', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': '1. Proportion of participants on glucose-lowering medications\n2. Proportion of participants on lipid-lowering medications\n3. Proportion of participants on blood pressure-lowering medications\n4. Proportion of participants on medication for pain relief\n5. Proportion of participants on weight loss medication\n6. Proportion of participants on medication used for psychiatric disorders (antidepressants, anxiolytics, antipsychotics)'}, {'measure': 'Long-term effects - incident cancer', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': '1. Proportion of participants with any diagnosis of cancer\n2. Proportion of participants with cancers known to be associated with obesity: GI tract including liver and kidney and reproduction organs (including breast for women and prostate for men)'}, {'measure': 'Long-term effects - fracture risk', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': '1. Proportion of participants with major osteoporotic fracture (hip, spine, wrist)\n2. Proportion of participants with any fracture'}, {'measure': 'Long-term effects - health economic and labour market attachment, employment status', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': 'Employment status each participant'}, {'measure': 'Long-term effects - health economic and labour market attachment, salary', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': 'Salary for each participant'}, {'measure': 'Long-term effects - health economic and labour market attachment, absence', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': 'Number of absence days'}, {'measure': 'Long-term effects - health economic and labour market attachment, sick leave', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': 'Proportion of participants with any sick leave'}, {'measure': 'Long-term effects - health economic and labour market attachment, long-term sick leave', 'timeFrame': '5, 10 and 20 years after randomisation', 'description': 'Proportion of participants with long-term sick leave (more than 4 weeks continuous sickness absence)'}], 'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': '104 weeks after randomisation', 'description': 'Weight (kg)'}], 'secondaryOutcomes': [{'measure': 'Weight loss (20%)', 'timeFrame': '104 weeks after randomisation', 'description': 'Proportion of participants with weight loss ≥20%'}, {'measure': 'Short-Form-36, mental component score', 'timeFrame': '104 weeks after randomisation', 'description': 'Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health)'}, {'measure': 'Gait speed', 'timeFrame': '104 weeks after randomisation', 'description': '4-metre gait speed (m/s)'}, {'measure': 'MetS-Z', 'timeFrame': '104 weeks after randomisation', 'description': 'Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '41093354', 'type': 'DERIVED', 'citation': 'Larsen SC, Heitmann BL, Wane S, Wielsoe S, Lindschou J, Jakobsen JC, Engstrom J, Specht IO, Christiansen AL, Jensen AKG, Bojsen-Moller KN, Bandholm T, Overbeck G, Kousgaard MB, Albury C, Reventlow S, Olsen KR, Kongstad LP, Madsbad S, Jebb SA, Dirksen C, Aveyard P, Waldorff FB; LightCOM team. Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial. BMJ Open. 2025 Oct 15;15(10):e107155. doi: 10.1136/bmjopen-2025-107155.'}], 'seeAlsoLinks': [{'url': 'https://www.regionh.dk/lightcom/uk/Pages/default.aspx', 'label': 'LightCOM website'}]}, '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 obesity class I or uncomplicated obesity class II or higher.', 'detailedDescription': "In the LightCARE trial, an intensive weight loss (IWL) intervention will compared with usual care. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication in three phases:\n\n* Induction' phase (week 0-12 after randomisation): total dietary replacement (TDR) programme and behavioural support with weight loss medication (WLM) if rate of weight loss is insufficient.\n* Weight loss continuation' phase (week 13-32 after randomisation): progression of dietary programme including reduction in use of TDR products, reintroduction of healthy foods, with behavioural support, introduction of physical activity, WLM (as required).\n* Maintenance' phase (week 33-104 after randomisation): Continued healthy diet and physical activity with WLM (if required), with return to induction phase if weight regain occurs induction, weight loss continuation, maintenance.\n\nUsual care will differ between the two countries (Denmark and the United Kingdom).\n\nIn Denmark, participants will receive a pamphlet on current obesity management guidelines from the Danish National Board of Health, and will be advised to contact their GP for potential referral to local municipality-based obesity management programmes. Furthermore, a notification will be sent to the participant's GP, informing that the participant has been enrolled in the trial and is randomised to usual care. The availability and structure of current obesity programmes varies between municipalities.\n\nIn the United Kingdom, participants will be offered to discuss weight management programmes available in their area with their GP practice; the programmes available referral routes vary slightly from place to place. Tier 2 weight management services are mostly commissioned by local authority, and therefore differ slightly across the 333 local authorities in England. These local community-based weight management services provide diet, nutrition, behavioural advice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Please note that participants need to be invited in order to take part in the trial.\n\nInclusion Criteria:\n\n1. Age ≥18 years and ≤60 years old at screening.\n2. BMI ≥30 kg/m2 or ≥27.5 kg/m2 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds (as reported by the participants).\n3. Informed consent.\n\nExclusion Criteria:\n\n1. Has severe and complex obesity, i.e., obesity class II (BMI≥35 if white or 32.5 if non-white) with one or more of these specific adiposity-related comorbidities: cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea (Appendix 1).\n2. Intending to become pregnant in the next two years, or pregnant, or breastfeeding.\n3. Use of WLM or GLP-1 agonist treatment within the last 3 months.\n4. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.\n5. Prior bariatric surgery, not including laparoscopic gastric banding, intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \\>1 year before screening.\n6. Diagnosis or treatment for eating disorder within the last 6 months.\n7. Any other disease that markedly compromises the participant's ability to adhere to the treatment programme or follow-up or is likely to mean that weight loss will not improve the person's length or quality of life, such as conditions limiting life expectancy.\n8. Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring any insulin therapy, phenylketonuria, or other conditions requiring special diets).\n9. Taking part in other research involving multidisciplinary obesity treatment that would compromise participation in this trial.\n10. Conditions that contraindicate or complicate GLP-1 or GIP agonist treatment (including history of pancreatitis)\n11. Another member of the household enrolled in the trial."}, 'identificationModule': {'nctId': 'NCT06321432', 'acronym': 'LightCARE', 'briefTitle': 'Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity: the LightCARE Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 2', 'orgStudyIdInfo': {'id': 'LightCARE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive weight loss intervention', 'description': '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.', 'interventionNames': ['Behavioral: Intensive weight loss intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Denmark: usual care offered by the GP or local municipality. The UK: usual care in primary care, Tier 2 weight management services.', 'interventionNames': ['Behavioral: Usual care']}], 'interventions': [{'name': 'Intensive weight loss intervention', 'type': 'BEHAVIORAL', 'description': 'Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.', 'armGroupLabels': ['Intensive weight loss intervention']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Usual care', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Carsten Dirksen', 'role': 'CONTACT'}], 'facility': 'The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2000', 'city': 'Frederiksberg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Addie J Frederiksen', 'role': 'CONTACT'}], 'facility': 'Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '2000', 'city': 'Frederiksberg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sofus C Larsen', 'role': 'CONTACT'}], 'facility': 'The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Maria Bleiback Clausen', 'role': 'CONTACT'}], 'facility': 'Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '2860', 'city': 'Søborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Julie Borgen Braget', 'role': 'CONTACT'}], 'facility': 'Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}, {'city': 'Ipswich', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Susan Jebb', 'role': 'CONTACT'}], 'facility': 'East of England RRDN', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Susan Jebb', 'role': 'CONTACT'}], 'facility': 'Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Susan Jebb', 'role': 'CONTACT'}], 'facility': 'North West RRDN', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Wolverhampton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Susan Jebb', 'role': 'CONTACT'}], 'facility': 'West Midlands RRDN', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'centralContacts': [{'name': 'Frans B Waldorff, Professor', 'role': 'CONTACT', 'email': 'fransw@sund.ku.dk', 'phone': '+4535327129'}, {'name': 'Susan Jebb, Professor', 'role': 'CONTACT', 'email': 'lightcare@phc.ox.ac.uk'}], 'overallOfficials': [{'name': 'Carsten Dirksen, Ass. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'When the results have been published', 'ipdSharing': 'YES', 'description': 'After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time', 'accessCriteria': 'Researchers with a protocol for their planned study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carsten Dirksen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'Copenhagen Trial Unit, Center for Clinical Intervention Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Carsten Dirksen', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}