LightWAY Trial Comparing Intensive Weight Loss Intervention With Usual Care for Adults Aged 18-60 With Severe and Complex Obesity

What this Trial Is About

Researchers are evaluating an intensive weight loss IWL intervention compared with usual care for adults with severe and complex obesity. This trial aims to assess the clinical benefits, potential harms, and cost-effectiveness of the IWL approach. The study focuses on people with a high body mass index BMI and related chronic diseases such as cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnea. The trial is randomized and double-blind, conducted in Denmark and the United Kingdom. The IWL intervention lasts two years and includes three phases. The induction phase weeks 0-12 uses a total dietary replacement program with behavioral support and weight loss medication if needed. The weight loss continuation phase weeks 13-32 gradually reintroduces healthy foods and physical activity while continuing behavioral support and medication if required. The maintenance phase weeks 33-104 focuses on sustaining a healthy diet and activity, with medication used as needed and a return to induction if weight regain occurs. Usual care differs by country, involving local obesity management programs or specialist NHS weight management services. Participants will be involved for two years with regular assessments. Researchers will monitor metabolic syndrome scores and body weight at 104 weeks, along with secondary measures like mental health, gait speed, and significant weight loss. The study includes behavioral support, dietary guidance, and medication management, with ongoing follow-up to track adherence and health outcomes throughout the study period.

Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity