NCT06309238

Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Carsten Dirksen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Intensive weight loss intervention	Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication
PROCEDURE	Bariatric surgery	Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)

Timeline

• Start date: 2024-05-08
• Primary completion: 2027-12-01
• Completion: 2048-12-01
• First posted: 2024-03-13
• Last updated: 2026-02-11

Locations

10 sites across 2 countries: Denmark, United Kingdom