Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial
- Conditions
- Obesity
- Interventions
- Behavioral: Intensive weight loss interventionProcedure: Bariatric surgery
- Registration Number
- NCT06309238
- Lead Sponsor
- Carsten Dirksen
- Brief 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
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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.
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Informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive weight loss intervention 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. Bariatric surgery Bariatric surgery Bariatric surgery: Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
- Primary Outcome Measures
Name Time Method MetS-Z 104 weeks after randomisation Metabolic syndrome severity Z-score
- Secondary Outcome Measures
Name Time Method Short-Form-36, mental component score 104 weeks after randomisation Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health)
Gait speed 104 weeks after randomisation 4-metre gait speed (m/s)
Weight 104 weeks after randomisation Weight (kg)
Trial Locations
- Locations (9)
The Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Queen Alexandra Hospital
🇬🇧Cosham, Portsmouth, United Kingdom
St Richard's Hospital
🇬🇧Chichester, Sussex, United Kingdom
Steno Diabetes Center Aarhus, Aarhus Universitets Hospital
🇩🇰Aarhus, Denmark
The Department of Medicine and Department of Surgery, University Hospital of South West Jutland
🇩🇰Esbjerg, Denmark
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
🇩🇰Hvidovre, Denmark
Department of Surgery, Viborg Regional Hospital
🇩🇰Viborg, Denmark
Southmead Hospital, North Bristol NHS Trust
🇬🇧Bristol, United Kingdom
Musgrove Park Hospital, Somerset Foundation NHS Trust
🇬🇧Taunton, United Kingdom