Introduction Effective treatment for clinical obesity is available but is rarely offered by healthcare systems, which often treat complications without treating the underlying cause. The LightWAY trial will investigate the clinical benefits and harms as well as cost-effectiveness of an intensive weight loss intervention compared with existing weight management programmes for people with clinical obesity.
Methods and analysis LightWAY is an investigator-initiated, international, randomised, parallel-group clinical superiority trial with blinded outcome assessment. Six hundred people seeking treatment for clinical obesity (body mass index ≥35 kg/m 2 with comorbidities) will be recruited in centres in the UK and Denmark and randomised 1:1 to one of two groups.
The experimental group will be offered a 2-year intensive weight loss programme providing support and advice to follow a total diet replacement programme, followed by gradual transition to an energy-reduced diet in combination with increased physical activity and if needed, prescription of weight loss medication.
BMJ Open published a clinical update in Research Highlights on 20 May 2026.
The item focuses on Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial protocol.
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