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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication
Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
Steno Diabetes Center Aarhus, Aarhus Universitets Hospital
Aarhus, Denmark
RECRUITINGThe Department of Medicine and Department of Surgery, University Hospital of South West Jutland
Esbjerg, Denmark
RECRUITINGThe Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, Denmark
RECRUITINGDepartment of Surgery, Viborg Regional Hospital
Viborg, Denmark
RECRUITINGSt Richard's Hospital
Chichester, Sussex, United Kingdom
RECRUITINGHartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
RECRUITINGSouthmead Hospital, North Bristol NHS Trust
Bristol, United Kingdom
RECRUITINGUniversity Hospital Coventry
Coventry, United Kingdom
RECRUITINGHuddersfield Royal Infirmary
Huddersfield, United Kingdom
RECRUITINGThe Whittington Hospital
London, United Kingdom
RECRUITING...and 4 more locations
MetS-Z
Metabolic syndrome severity Z-score
Time frame: 104 weeks after randomisation
Weight
Weight (kg)
Time frame: 104 weeks after randomisation
Gait speed
4-metre gait speed (m/s)
Time frame: 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)
Time frame: 104 weeks after randomisation
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