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Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial

Sponsor: Carsten Dirksen

NCT ID: NCT06309238

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Intensive weight loss intervention (behavioural), Bariatric surgery (procedure)
How long the study runs
Study runs about 295 months (dates as stated)
About the drug or intervention
Intensive weight loss intervention — behavioural: Intensive weight loss intervention, incl. · Bariatric surgery — procedure: Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
Patient visit burden
Not specified by the sponsor

In plain English

This study, called LightBAR, compares an intensive weight loss programme with weight loss (bariatric) surgery for adults with severe and complex obesity. Participants must be invited to take part. The trial covers the UK and Denmark, and is sponsored by Carsten Dirksen.

Who can take part

  • Aged 18 to 60 at screening
  • Eligible for and willing to have bariatric surgery under national health rules (for example, in the UK: a BMI of 35–40 with another significant illness such as type 2 diabetes or high blood pressure, or a BMI of 40 or above, plus care or willingness to attend a specialist tier 3 obesity service)
  • Fit for anaesthesia and surgery
  • Able to give informed consent
  • Must have lost at least 5% of body weight in the 12 weeks before joining

Who may not be able to

  • Previous bariatric or hiatal surgery (some exceptions for removed stomach balloons or bypass sleeves over 1 year ago)
  • Use of weight loss medicines (including liraglutide and semaglutide for diabetes) in the last 3 months
  • Health conditions that make total diet replacement unsafe, such as insulin-treated diabetes or phenylketonuria
  • Conditions that make GLP-1 medicines unsafe, such as past pancreatitis or allergy
  • Conditions that make surgery difficult, such as Crohn's disease, liver cirrhosis, or a large hiatus hernia (over 5cm)
  • Unstable mental health problems, recent alcohol or medicine misuse, or cancer treatment in the last 5 years
  • Pregnant, breastfeeding, or planning pregnancy in the next two years
  • Taking part in other obesity research that could clash with this trial
  • Another person in the same household already in the trial
  • Diagnosis of or treatment for a severe eating disorder in the last 6 months

What taking part involves

  • • An intensive weight loss intervention
  • • Or bariatric surgery (for those in Denmark, an 8% weight loss and stopping smoking are required before surgery)

Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 60 Years
Who
All
Number of participants
500
Started
2024-05-08
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for obesity
  • • NA - 500 participants
  • • With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity

Who can take part?

  • • Ages 18 Years to 60 Years
  • • Diagnosed with obesity

Where?

  • • Chichester - St Richard's Hospital
  • • Birmingham - Hartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
  • • Bristol - Southmead Hospital, North Bristol NHS Trust
  • • Coventry - University Hospital Coventry
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option.

More detail

In the LightBAR trial, an intensive weight loss (IWL) intervention will be compared with bariatric surgery. The IWL consists of 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. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication. Bariatric surgery will be standard Roux-en-Y gastric bypass or sleeve gastrectomy.

Obesity

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 60 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ as well as smoking cessation

What the study is looking for

  • ✓Aged 18 to 60 years (inclusive) at time of screening.
  • ✓Eligible for and willing to undergo bariatric surgery, i.e., fulfilment of criteria for bariatric surgery from the...
  • ✓Fit for anaesthesia and surgery.
  • ✓agreement to take part.

Who cannot take part

  • ✗Prior bariatric or hiatal surgery, not including intragastric balloons or duodenal-jejunal bypass sleeve...
  • ✗Use of any WLM (including liraglutide and semaglutide for diabetes) within last 3 months.
  • ✗Conditions that contraindicate or complicate treatment with GLP-1 receptor analogues (including history of...
  • ✗Pregnant or planning pregnancy in the next two years or currently breast feeding.
  • ✗Not achieving a 5% weight loss within 12 weeks prior to randomisation.
See the full criteria
Please note that participants need to be invited in order to take part in the trial. Inclusion Criteria: * Aged 18 to 60 years (inclusive) at time of screening. * Eligible for and willing to undergo bariatric surgery, i.e., fulfilment of criteria for bariatric surgery from the respective national health authorities: * DK: BMI ≥ 35 kg/m2 with one or more of the following: T2D, severe hypertension, sleep apnoea requiring treatment, symptomatic arthrosis in lower extremities, female infertility related to overweight, or BMI\>40 kg/m2 with other strong medical reasons for weight loss (28). Prior to surgery, an 8% weight loss is required as well as smoking cessation. * UK: BMI of 35 kg/m2 to 40 kg/m2 and other significant disease (e.g., type 2 diabetes or high blood pressure), or BMI ≥40 kg/m2. Has been or is willing to receive intensive management in a specialist tier 3 obesity service (29). * Fit for anaesthesia and surgery. * Informed consent. Exclusion Criteria: * Prior bariatric or hiatal surgery, not including intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \>1 year before screening. * Use of any WLM (including liraglutide and semaglutide for diabetes) within last 3 months. * Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring basal bolus insulin therapy or insulin pump therapy (for Denmark) and any diabetes requiring insulin therapy (for UK), phenylketonuria, or other conditions requiring strict adherence to special diets). * Conditions that contraindicate or complicate treatment with GLP-1 receptor analogues (including history of pancreatitis or known allergies). * Conditions that contraindicate or complicate bariatric surgery (GI motility disorders, large abdominal wall hernia, large hiatus hernia (\>5cm), Crohn's disease, liver cirrhosis, or other conditions preventing laparoscopic bariatric surgery e.g. multiple previous abdominal surgery). * Conditions that contraindicate or complicate study adherence and bariatric surgery (mental disorder, unstable psychiatric disease, recent history of alcohol/medication abuse, cancer treatment within 5 years). * Pregnant or planning pregnancy in the next two years or currently breast feeding. * Not achieving a 5% weight loss within 12 weeks prior to randomisation. * People taking part in other research involving multidisciplinary obesity treatment that would compromise their participation in this trial. * Another member of the household enrolled in the trial. * Diagnosis of or treatment for severe eating disorder within the last 6 months.

Where Is This Study? (10 UK sites)

St Richard's Hospital

Chichester PO19 6SE, United Kingdom

Recruiting

Hartlands Hospital, University Hospitals Birmingham NHS Foundation Trust

Birmingham B9 5SS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Southmead Hospital, North Bristol NHS Trust

Bristol BS10 5NB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

University Hospital Coventry

Coventry, United Kingdom

Recruiting
Hospital R&D contact (matched)

Josie Goodby

research@uhcw.nhs.uk02476 965244

Huddersfield Royal Infirmary

Huddersfield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

The Whittington Hospital

London N19 5NF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Support Team

whh-tr.researchsupport@nhs.net0207 288 3585

King's College Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Luton and Dunstable University Hospital

Luton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr. Mohammad Wasil. Assistant Director of RD&I

research.bedford@bedsft.nhs.ukContact:

Sunderland Royal Hospital

Sunderland SR4 7TP, United Kingdom

Recruiting

Musgrove Park Hospital, Somerset Foundation NHS Trust

Taunton TA1 5DA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Karen Tanner

Research@somersetft.nhs.uk01935 384559

How to Get in Touch

Kirstine N Bojsen-Møller, MD, PhD

Sponsor contact

CONTACT

+45 3862 3862 kirstine.nyvold.bojsen-moeller@regionh.dk

Susan Jebb, Professor

Sponsor contact

CONTACT

lightbar@phc.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-08