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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source Copenhagen University Hospital, Hvidovre
Contact Carsten Dirksen, Ass. Prof.
Phone +45 29425320
Email carsten.dirksen@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

In the LightWAY trial, an intensive weight loss (IWL) intervention will be compared with with usual care. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication in three phases: - 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. - 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). - 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. Usual care will differ between the two countries (Denmark and the United Kingdom). In 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. In the United Kingdom, participants are eligible for referral into an NHS Tier 3 weight management service. These services are commissioned by integrated care boards, and can therefore differ slightly across the 42 regions within the UK. These are specialist weight management clinics that provide non-surgical, intensive medical management with a multidisciplinary approach to care. These clinics often consist of specialist doctors, nurses, dieticians and physiotherapists/exercise therapists, and include psychological support.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intensive weight loss intervention
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
Usual care
Usual care

Locations

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

Sponsors (6)

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

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

Outcome

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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