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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.
Full 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.
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Inclusion and exclusion criteria
Please note that participants need to be invited in order to take part in the trial.
Inclusion Criteria:
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.
Exclusion Criteria:
Primary purpose
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500 participants in 2 patient groups
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Central trial contact
Susan Jebb, Professor; Kirstine N Bojsen-Møller, MD, PhD
Data sourced from clinicaltrials.gov
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