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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (10 UK sites)
St Richard's Hospital
Chichester PO19 6SE, United Kingdom
Hartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham B9 5SS, United Kingdom
Southmead Hospital, North Bristol NHS Trust
Bristol BS10 5NB, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
The Whittington Hospital
London N19 5NF, United Kingdom
King's College Hospital
London, United Kingdom
Luton and Dunstable University Hospital
Luton, United Kingdom
Dr. Mohammad Wasil. Assistant Director of RD&I
research.bedford@bedsft.nhs.ukContact:Sunderland Royal Hospital
Sunderland SR4 7TP, United Kingdom
Musgrove Park Hospital, Somerset Foundation NHS Trust
Taunton TA1 5DA, United Kingdom
How to Get in Touch
Kirstine N Bojsen-Møller, MD, PhD
Sponsor contactCONTACT
Susan Jebb, Professor
Sponsor contactCONTACT
