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Active, not recruitingNCT06321458LightWAYUpdated Aug 24, 2026

Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity

An interventional study of Intensive weight loss intervention and Usual care in Obesity, sponsored by Carsten Dirksen. Active, not recruiting at 14 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Carsten Dirksen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
605
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 605 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Carsten Dirksen is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Please note that participants need to be invited in order to take part in the trial

Inclusion criteria

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

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, 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
605 participants (actual)

Study arms

  • Experimental
    Intensive weight loss intervention

    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.

    Behavioral: Intensive weight loss intervention

  • Active comparator
    Usual care

    Denmark: usual care offered by the GP or local municipality. The UK: tier 3 weight management services.

    Behavioral: Usual care

Interventions

  • BehavioralIntensive weight loss intervention

    Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.

  • BehavioralUsual care

    Usual care

06

What researchers measure

Primary outcomes

  1. MetS-Z

    Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome)

    Time frame: 104 weeks after randomisation

  2. Weight

    Weight (kg)

    Time frame: 104 weeks after randomisation

Secondary outcomes

  1. Short-Form-36, mental component score

    Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health)

    Time frame: 104 weeks after randomisation

  2. Gait speed

    4-metre gait speed (m/s)

    Time frame: 104 weeks after randomisation

  3. Weight loss (20%)

    Proportion of participants with weight loss ≥20%

    Time frame: 104 weeks after randomisation

Other outcomes

  1. SAE

    Proportion of participants with at least one serious adverse event during the intervention period (according to ICH-GCP guidelines)

    Time frame: 104 weeks after randomisation

  2. Incident eating disorders

    Proportion of participants with incident eating disorders during the intervention period

    Time frame: 104 weeks after randomisation

  3. Bone mineral density (BMD) assessed by DXA

    1. Bone mineral density (g/cm²) of hip (total hip and femoral neck), 2. Bone mineral density (g/cm²) of lumbar region

    Time frame: 104 weeks after randomisation

  4. Body composition - waist circumference

    Waist circumference (cm)

    Time frame: 104 weeks after randomisation

  5. Body composition - fat percentage

    1. Body fat percentage 2. Visceral fat percentage 3. Subcutaneous fat percentage

    Time frame: 104 weeks after randomisation

  6. Body composition - weight loss (10%)

    Proportion of participants with weight loss ≥10%

    Time frame: 104 weeks after randomisation

  7. Physical functioning - SENS

    Objectively measured moderate to vigorous physical activity (MVPA) using SENS Motion accelerometers (hours/day)

    Time frame: 104 weeks after randomisation

  8. Physical functioning - SF-36

    Short Form 36 (SF-36) physical component score (scale from 0-100, higher scores indicate better physical health)

    Time frame: 104 weeks after randomisation

  9. Physical functioning - sit to stand test

    Number of sit to stands completed in the 30 Second Sit to Stand test

    Time frame: 104 weeks after randomisation

  10. Sleep

    Sleep duration using SENS Motion accelerometers (hours/day)

    Time frame: 104 weeks after randomisation

  11. Medications during the intervention period

    1. Proportion of participants prescribed glucose-lowering medications (number, type) 2. Proportion of participants prescribed lipid-lowering medications (number, type) 3. Proportion of participants prescribed blood pressure-lowering medications (number, type) 4. Proportion of participants prescribed medication for pain relief (number, type) 5. Proportion of participants prescribed use of medications for psychiatric disorders (number, type)

    Time frame: 104 weeks after randomisation

  12. Metabolic health - blood pressure

    Systolic and diastolic blood pressure (mmHg)

    Time frame: 104 weeks after randomisation

  13. Metabolic health - pulse

    Pulse rate (beats per minute)

    Time frame: 104 weeks after randomisation

  14. Metabolic health - Hb1Ac

    Haemoglobin A1c (mmol/mol)

    Time frame: 104 weeks after randomisation

  15. Metabolic health - insulin

    Fasting insulin concentration (pmol/L)

    Time frame: 104 weeks after randomisation

  16. Metabolic health - HOMA2-IR

    HOMA2-IR (calculated from glucose and C-peptide concentration) (ratio)

    Time frame: 104 weeks after randomisation

  17. Metabolic health - lipids

    Fasting lipid profile (HDL, LDL and triglycerides) (mmol/L)

    Time frame: 104 weeks after randomisation

  18. Metabolic health - eGFR

    Estimated Glomerular Filtration Rate (eGFR), creatinine (µmol/L), calculated from creatinine, sex and years

    Time frame: 104 weeks after randomisation

  19. Metabolic health - hsCRP

    High-sensitivity C-reactive protein (hsCRP), mg/L

    Time frame: 104 weeks after randomisation

  20. Metabolic health - Fib4

    Fib-4 (ALT/AST/platelets) (ratio)

    Time frame: 104 weeks after randomisation

  21. Metabolic health - proteinuria

    Proteinuria, measured as urine albumin/creatinine (ratio)

    Time frame: 104 weeks after randomisation

  22. Metabolic health - TSH

    Thyroid-stimulating hormone (IU/L)

    Time frame: 104 weeks after randomisation

  23. Mental health - MDI

    Major Depression Inventory (MDI) (scale from 0-50, higher scores indicate more symptoms of depression)

    Time frame: 104 weeks after randomisation

  24. Mental health - WBIS-M

    Weight Bias Internalization Scale (WBIS-M) score (scale from 1-7, higher scores indicate higher degree of internalised weight bias)

    Time frame: 104 weeks after randomisation

  25. Mental health - EDE-Q

    Eating Disorder Examination Questionnaire (EDE-Q) score (scale from 0 to 6, higher scores indicate higher degree of eating disorder)

    Time frame: 104 weeks after randomisation

  26. 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)

    Time frame: 104 weeks after randomisation

  27. Labour market attachment - days of sick leave

    Self-reported number of days sick leave during follow-up

    Time frame: 104 weeks after randomisation

  28. Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs usual care

    1. Common gene variants with low to moderate effect on the phenotype for the construction of aggregate genetic risk scores 2. 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

    Time frame: 104 weeks after randomisation

  29. 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)

    Time frame: 104 weeks after randomisation

  30. 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)

    Time frame: 104 weeks after randomisation

  31. Health economy: Within-trial cost-effectiveness analysis - costs

    24-month costs, DKK

    Time frame: 104 weeks after randomisation

  32. Health economy: Within-trial cost-effectiveness analysis - QALY

    Incremental cost per quality-adjusted-life-year (QALY) gained, DKK

    Time frame: 104 weeks after randomisation

  33. Health economy: Model-based cost-effectiveness analysis - QALY

    Predicted lifetime QALYs gained

    Time frame: 104 weeks after randomisation

  34. Health economy: Model-based cost-effectiveness analysis - healthcare costs

    Predicted lifetime healthcare costs, DKK

    Time frame: 104 weeks after randomisation

  35. Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios

    Long-term incremental cost effectiveness ratios

    Time frame: 104 weeks after randomisation

  36. 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

    Time frame: 5, 10 and 20 years after randomisation

  37. Long-term effects - prescription patterns

    1. Proportion of participants on glucose-lowering medications 2. Proportion of participants on lipid-lowering medications 3. Proportion of participants on blood pressure-lowering medications 4. Proportion of participants on medication for pain relief 5. Proportion of participants on weight loss medication 6. Proportion of participants on medication used for psychiatric disorders (antidepressants, anxiolytics, antipsychotics)

    Time frame: 5, 10 and 20 years after randomisation

  38. Long-term effects - incident cancer

    1. Proportion of participants with any diagnosis of cancer 2. 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)

    Time frame: 5, 10 and 20 years after randomisation

  39. Long-term effects - fracture risk

    1. Proportion of participants with major osteoporotic fracture (hip, spine, wrist) 2. Proportion of participants with any fracture

    Time frame: 5, 10 and 20 years after randomisation

  40. Long-term effects - health economic and labour market attachment, employment status

    Employment status for each participant

    Time frame: 5, 10 and 20 years after randomisation

  41. Long-term effects - health economic and labour market attachment, salary

    Salary for each participant

    Time frame: 5, 10 and 20 years after randomisation

  42. Long-term effects - health economic and labour market attachment, absence

    Number of absence days

    Time frame: 5, 10 and 20 years after randomisation

  43. Long-term effects - health economic and labour market attachment, sick leave

    Proportion of participants with any sick leave

    Time frame: 5, 10 and 20 years after randomisation

  44. 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)

    Time frame: 5, 10 and 20 years after randomisation

07

Study locations

14 sites
  • Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet
    Frederiksberg, 2000, Denmark
  • The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg
    Frederiksberg, 2000, Denmark
  • Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse
    Hvidovre, 2650, Denmark
  • The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
    Hvidovre, 2650, Denmark
  • Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering
    Søborg, 2860, Denmark
  • Cwm Taf Morgannwg University Health Board
    Abercynon, United Kingdom
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, United Kingdom
  • University Hospitals of Derby and Burton NHS Foundation Trust
    Derby, United Kingdom
  • Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)
    Leeds, United Kingdom
  • South West Peninsula RRDN
    Plymouth, United Kingdom
  • Powys Teaching Health Board
    Powys, United Kingdom
  • South Central RRDN
    Southampton, United Kingdom
  • Torbay and South Devon NHS Trust
    Torquay, United Kingdom
  • Royal Wolverhampton NHS Trust
    Wolverhampton, United Kingdom
08

References and documents

Publications

  • Wane S, Aveyard P, Wielsoe S, Larsen SC, Scragg J, Lindschou J, Jakobsen JC, Engstrom J, Specht IO, Christiansen AL, Jensen AKG, Bandholm T, Albury C, Overbeck G, Reventlow S, Olsen KR, Fahr P, Bojsen-Moller KN, Heitmann BL, Waldorff FB, Madsbad S, Dirksen C, Jebb SA. Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial protocol. BMJ Open. 2026 May 20;16(5):e107240. doi: 10.1136/bmjopen-2025-107240. PubMed 42161553 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06321458
Lead sponsor
Carsten Dirksen
Collaborators
University of Copenhagen, University of Southern Denmark, University of Oxford, Copenhagen Trial Unit, Center for Clinical Intervention Research
Responsible party
Carsten Dirksen (Associate Professor, Copenhagen University Hospital, Hvidovre) — Sponsor-investigator
First posted
Mar 20, 2024
Start date
Apr 29, 2024
Primary completion
Mar 2028 (estimated)
Completion
Dec 2048 (estimated)
Last update
Aug 24, 2026

Study contacts

Carsten Dirksen
study chair · Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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