ObesityLightBARNCT06309238
Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial
A study testing Intensive weight loss intervention and Bariatric surgery in people with Obesity, run by Carsten Dirksen at 14 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Intensive weight loss intervention and Bariatric surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 8 May 2024to Dec 2048
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 11Show fewer
- 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.
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Susan Jebb, Professor contact
14 sites in 2 countries
United Kingdom10 sites, 10 recruiting
- Recruiting
Hartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B9 5SS
Tom Wiggins
- Recruiting
Southmead Hospital, North Bristol NHS Trust
Bristol, BS10 5NB
Dimitri Pournaras
- Recruiting
St Richard's Hospital
Chichester, Sussex, PO19 6SE
Richard Newton
- Recruiting
University Hospital Coventry
Coventry
- Recruiting
Huddersfield Royal Infirmary
Huddersfield
- Recruiting
The Whittington Hospital
London, N19 5NF
Chetan Parmer
- Recruiting
King's College Hospital
London
- Recruiting
Luton and Dunstable University Hospital
Luton
- Recruiting
Sunderland Royal Hospital
Sunderland, SR4 7TP
Aya Musbahi
- Recruiting
Musgrove Park Hospital, Somerset Foundation NHS Trust
Taunton, TA1 5DA
Richard Welbourn
Denmark4 sites, 4 recruiting
- Recruiting
Steno Diabetes Center Aarhus, Aarhus Universitets Hospital
Aarhus, 8200
Jens Bruun
- Recruiting
The Department of Medicine and Department of Surgery, University Hospital of South West Jutland
Esbjerg, 6700
Claus Borg Juhl
- Recruiting
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, 2650
Kirstine N Bojsen-Møller
- Recruiting
Department of Surgery, Viborg Regional Hospital
Viborg, 8800
Peter Rask
About this study
Official title: Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 4
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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- Intensive weight loss intervention, Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive weight loss interventionBehavioural
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication
Bariatric surgeryProcedure or surgery
Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
| Study group | Role | What they receive |
|---|---|---|
| Intensive weight loss intervention | Experimental | 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. Receives: Behavioral: Intensive weight loss intervention |
| Bariatric surgery | Active comparator | Bariatric surgery: Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
MetS-Z
Metabolic syndrome severity Z-score
Measured: 104 weeks after randomisation
Secondary outcomes (3)
Weight
Weight (kg)
Measured: 104 weeks after randomisation
Gait speed
4-metre gait speed (m/s)
Measured: 104 weeks after randomisation
Short-Form-36, mental component score
Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health)
Measured: 104 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start8 May 2024
- Primary completionMar 2029 (estimated)
- Study completionDec 2048 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carsten Dirksen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark, University of Oxford, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Carsten Dirksen, Copenhagen University Hospital, Hvidovre
- Investigators
- Carsten Dirksen, Ass Professor, Study chair, Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309238
- Sponsor's protocol ID
- LightBAR
- Acronym
- LightBAR
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the results have been published, we aim 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.
Publications
Tomova-Olsen SA, Kousgaard MB, Jensen KT, Reventlow S, Christiansen AL, Bojsen-Moller KN, Dirksen C, Overbeck G. Time, money, and weight loss: a qualitative study exploring patients' perspectives on randomization for bariatric surgery vs. an intensive non-surgical weight loss program. Trials. 2025 Apr 4;26(1):121. doi: 10.1186/s13063-025-08816-8.
PubMed 40186310
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 4
- ClinicalTrials.gov ID
- NCT06309238
- Acronym / sponsor ID
- LightBAR / LightBAR
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Carsten DirksenUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark, University of Oxford, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- 8 May 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Dec 2048 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive weight loss intervention | Experimental | Behavioral: Intensive weight loss interventionThe 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. |
| Bariatric surgery | Active comparator | Procedure: Bariatric surgeryBariatric surgery: Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
- Fit for anaesthesia and surgery.
- Informed consent.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive weight loss interventionIntensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication | Behavioural | Intensive weight loss intervention |
| Bariatric surgeryRoux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG) | Procedure or surgery | Bariatric surgery |
Primary outcome
MetS-Z
Time frame: 104 weeks after randomisation
Metabolic syndrome severity Z-score
3 secondary outcomes
Weight
Time frame: 104 weeks after randomisation
Gait speed
Time frame: 104 weeks after randomisation
Short-Form-36, mental component score
Time frame: 104 weeks after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 40186310Tomova-Olsen SA, Kousgaard MB, Jensen KT, Reventlow S, Christiansen AL, Bojsen-Moller KN, Dirksen C, Overbeck G. Time, money, and weight loss: a qualitative study exploring patients' perspectives on randomization for bariatric surgery vs. an intensive non-surgical weight loss program. Trials. 2025 Apr 4;26(1):121. doi: 10.1186/s13063-025-08816-8.
- LightCOM websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the results have been published, we aim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Jebb, Professor contact
Carsten Dirksen, Ass Professor study chair
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive weight loss intervention and Bariatric surgery in people with Obesity, run by Carsten Dirksen at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirstine N Bojsen-Møller, MD, PhD (+45 3862 3862, kirstine.nyvold.bojsen-moeller@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MetS-Z (time frame: 104 weeks after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.