Obesity Clinical Trial
— LightWAYOfficial title:
Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity: the LightWAY Randomised Trial: Lighthouse Consortium on Obesity Management (LightCOM) Trial no 3
NCT number | NCT06321458 |
Other study ID # | LightWAY |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 29, 2024 |
Est. completion date | December 2048 |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2048 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Please note that participants need to be invited in order to take part in the trial Inclusion Criteria: 1. Age =18 years and =60 years old at screening. 2. Has severe and complex obesity i.e. BMI>35 or >32.5 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds and with one or more of these specific adiposity-related chronic diseases of cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea. 3. Provides informed consent. Exclusion Criteria: 1. Intending to become pregnant in the next two years or pregnant or breastfeeding. 2. Use of WLM or GLP-1 agonist treatment within the last three months. 3. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer. 4. 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. 5. Diagnosis of or treatment for severe eating disorder within the last 6 months. 6. 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. 7. Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, coeliac disease, or other conditions requiring special diets). 8. Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis) 9. Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial. 10. Another member of the household enrolled in the trial. |
Country | Name | City | State |
---|---|---|---|
Denmark | Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet | Frederiksberg | |
Denmark | The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg | Frederiksberg | |
Denmark | Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse | Hvidovre | |
Denmark | The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre | Hvidovre | |
Denmark | Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering | Søborg | |
United Kingdom | IHR CRN: Thames Valley and South Midlands | Oxford |
Lead Sponsor | Collaborator |
---|---|
Carsten Dirksen | Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Bristol, University of Copenhagen, University of Oxford, University of Southern Denmark |
Denmark, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | SAE | Proportion of participants with at least one serious adverse event during the intervention period (according to ICH-GCP guidelines) | 104 weeks after randomisation | |
Other | Incident eating disorders | Proportion of participants with incident eating disorders during the intervention period | 104 weeks after randomisation | |
Other | Bone mineral density (BMD) assessed by DXA | Bone mineral density (g/cm²) of hip (total hip and femoral neck),
Bone mineral density (g/cm²) of lumbar region |
104 weeks after randomisation | |
Other | Body composition - waist circumference | Waist circumference (cm) | 104 weeks after randomisation | |
Other | Body composition - fat percentage | Body fat percentage
Visceral fat percentage Subcutaneous fat percentage |
104 weeks after randomisation | |
Other | Body composition - weight loss (10%) | Proportion of participants with weight loss =10% | 104 weeks after randomisation | |
Other | Physical functioning - SENS | Objectively measured moderate to vigorous physical activity (MVPA) using SENS Motion accelerometers (hours/day) | 104 weeks after randomisation | |
Other | Physical functioning - SF-36 | Short Form 36 (SF-36) physical component score (scale from 0-100, higher scores indicate better physical health) | 104 weeks after randomisation | |
Other | Physical functioning - sit to stand test | Number of sit to stands completed in the 30 Second Sit to Stand test | 104 weeks after randomisation | |
Other | Sleep | Sleep duration using SENS Motion accelerometers (hours/day) | 104 weeks after randomisation | |
Other | Medications during the intervention period | Proportion of participants prescribed glucose-lowering medications (number, type)
Proportion of participants prescribed lipid-lowering medications (number, type) Proportion of participants prescribed blood pressure-lowering medications (number, type) Proportion of participants prescribed medication for pain relief (number, type) Proportion of participants prescribed use of medications for psychiatric disorders (number, type) |
104 weeks after randomisation | |
Other | Metabolic health - blood pressure | Systolic and diastolic blood pressure (mmHg) | 104 weeks after randomisation | |
Other | Metabolic health - pulse | Pulse rate (beats per minute) | 104 weeks after randomisation | |
Other | Metabolic health - Hb1Ac | Haemoglobin A1c (mmol/mol) | 104 weeks after randomisation | |
Other | Metabolic health - insulin | Fasting insulin concentration (pmol/L) | 104 weeks after randomisation | |
Other | Metabolic health - HOMA2-IR | HOMA2-IR (calculated from glucose and C-peptide concentration) (ratio) | 104 weeks after randomisation | |
Other | Metabolic health - lipids | Fasting lipid profile (HDL, LDL and triglycerides) (mmol/L) | 104 weeks after randomisation | |
Other | Metabolic health - eGFR | Estimated Glomerular Filtration Rate (eGFR), creatinine (µmol/L), calculated from creatinine, sex and years | 104 weeks after randomisation | |
Other | Metabolic health - hsCRP | High-sensitivity C-reactive protein (hsCRP), mg/L | 104 weeks after randomisation | |
Other | Metabolic health - Fib4 | Fib-4 (ALT/AST/platelets) (ratio) | 104 weeks after randomisation | |
Other | Metabolic health - proteinuria | Proteinuria, measured as urine albumin/creatinine (ratio) | 104 weeks after randomisation | |
Other | Metabolic health - TSH | Thyroid-stimulating hormone (IU/L) | 104 weeks after randomisation | |
Other | Mental health - MDI | Major Depression Inventory (MDI) (scale from 0-50, higher scores indicate more symptoms of depression) | 104 weeks after randomisation | |
Other | Mental health - WBIS-M | Weight Bias Internalization Scale (WBIS-M) score (scale from 1-7, higher scores indicate higher degree of internalised weight bias) | 104 weeks after randomisation | |
Other | Mental health - EDE-Q | Eating Disorder Examination Questionnaire (EDE-Q) score (scale from 0 to 6, higher scores indicate higher degree of eating disorder) | 104 weeks after randomisation | |
Other | Labour market attachment - WPAI | Work productivity and impairment (WPAI) score points (scale from 0-100, higher scores indicate more limitations in ability to work and lower productivity) | 104 weeks after randomisation | |
Other | Labour market attachment - days of sick leave | Self-reported number of days sick leave during follow-up | 104 weeks after randomisation | |
Other | Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care | Common gene variants with low to moderate effect on the phenotype for the construction of aggregate genetic risk scores
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 |
104 weeks after randomisation | |
Other | Health economy: Within-trial cost-effectiveness analysis - quality of life, index score | Quality of life (measured using the 5-level EQ-5D version, EQ-5D-5L index score (score between -1 and 1, higher scores indicate better health) | 104 weeks after randomisation | |
Other | Health economy: Within-trial cost-effectiveness analysis - quality of life, VAS | 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) | 104 weeks after randomisation | |
Other | Health economy: Within-trial cost-effectiveness analysis - costs | 24-month costs, DKK | 104 weeks after randomisation | |
Other | Health economy: Within-trial cost-effectiveness analysis - QALY | Incremental cost per quality-adjusted-life-year (QALY) gained, DKK | 104 weeks after randomisation | |
Other | Health economy: Model-based cost-effectiveness analysis - QALY | Predicted lifetime QALYs gained | 104 weeks after randomisation | |
Other | Health economy: Model-based cost-effectiveness analysis - healthcare costs | Predicted lifetime healthcare costs, DKK | 104 weeks after randomisation | |
Other | Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios | Long-term incremental cost effectiveness ratios | 104 weeks after randomisation | |
Other | Long-term effects - mortality and major cardiovascular disease (CVD) | Proportion of participants who die from any cause
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 |
5, 10 and 20 years after randomisation | |
Other | Long-term effects - prescription patterns | Proportion of participants on glucose-lowering medications
Proportion of participants on lipid-lowering medications Proportion of participants on blood pressure-lowering medications Proportion of participants on medication for pain relief Proportion of participants on weight loss medication Proportion of participants on medication used for psychiatric disorders (antidepressants, anxiolytics, antipsychotics) |
5, 10 and 20 years after randomisation | |
Other | Long-term effects - incident cancer | Proportion of participants with any diagnosis of cancer
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) |
5, 10 and 20 years after randomisation | |
Other | Long-term effects - fracture risk | Proportion of participants with major osteoporotic fracture (hip, spine, wrist)
Proportion of participants with any fracture |
5, 10 and 20 years after randomisation | |
Other | Long-term effects - health economic and labour market attachment, employment status | Employment status for each participant | 5, 10 and 20 years after randomisation | |
Other | Long-term effects - health economic and labour market attachment, salary | Salary for each participant | 5, 10 and 20 years after randomisation | |
Other | Long-term effects - health economic and labour market attachment, absence | Number of absence days | 5, 10 and 20 years after randomisation | |
Other | Long-term effects - health economic and labour market attachment, sick leave | Proportion of participants with any sick leave | 5, 10 and 20 years after randomisation | |
Other | Long-term effects - health economic and labour market attachment, long-term sick leave | Proportion of participants with long-term sick leave (more than 4 weeks continuous sickness absence) | 5, 10 and 20 years after randomisation | |
Primary | MetS-Z | Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome) | 104 weeks after randomisation | |
Primary | Weight | Weight (kg) | 104 weeks after randomisation | |
Secondary | Short-Form-36, mental component score | Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health) | 104 weeks after randomisation | |
Secondary | Gait speed | 4-metre gait speed (m/s) | 104 weeks after randomisation | |
Secondary | Weight loss (20%) | Proportion of participants with weight loss =20% | 104 weeks after randomisation |
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