Actively Recruiting
Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial
Led by Carsten Dirksen · Updated on 2026-02-11
500
Participants Needed
10
Research Sites
1281 weeks
Total Duration
On this page
Sponsors
C
Carsten Dirksen
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 60 years (inclusive) at time of screening.
- Eligible for and willing to undergo bariatric surgery, meeting national criteria: For Denmark, BMI ≥35 kg/m2 with related conditions or BMI >40 kg/m2 with strong medical reasons; for the UK, BMI 35-40 kg/m2 with other significant disease or BMI ≥40 kg/m2.
- Fit for anesthesia and surgery.
- Provided informed consent.
You will not qualify if you...
- Prior bariatric or hiatal surgery, except if intragastric balloons or duodenal-jejunal bypass sleeve removed more than 1 year before screening.
- Use of any weight loss medication within the last 3 months.
- Conditions contraindicating total diet replacement, including type 1 diabetes or insulin-requiring diabetes, phenylketonuria, or other special diet needs.
- Conditions contraindicating treatment with GLP-1 receptor analogues, including history of pancreatitis or allergies.
- Conditions contraindicating bariatric surgery, such as GI motility disorders, large abdominal wall or hiatus hernias, Crohn’s disease, liver cirrhosis, or multiple previous abdominal surgeries.
- Conditions affecting study adherence or surgery, including mental disorders, unstable psychiatric disease, recent substance abuse, or cancer treatment within 5 years.
- Pregnant, planning pregnancy within 2 years, or breastfeeding.
- Not achieving 5% weight loss within 12 weeks before randomization.
- Participation in other multidisciplinary obesity treatment research.
- Another household member enrolled in the trial.
- Diagnosis or treatment for severe eating disorder within the last 6 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Steno Diabetes Center Aarhus, Aarhus Universitets Hospital
Aarhus, Denmark, 8200
Actively Recruiting
2
The Department of Medicine and Department of Surgery, University Hospital of South West Jutland
Esbjerg, Denmark, 6700
Actively Recruiting
3
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
4
Department of Surgery, Viborg Regional Hospital
Viborg, Denmark, 8800
Actively Recruiting
5
St Richard's Hospital
Chichester, Sussex, United Kingdom, PO19 6SE
Actively Recruiting
6
Hartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
7
Southmead Hospital, North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
8
The Whittington Hospital
London, United Kingdom, N19 5NF
Actively Recruiting
9
Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 7TP
Actively Recruiting
10
Musgrove Park Hospital, Somerset Foundation NHS Trust
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
Research Team
K
Kirstine N Bojsen-Møller, MD, PhD
CONTACT
S
Susan Jebb, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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