Effects of Intensive Lifestyle Interventions (ILI) on Weight Loss and Cardiometabolic Risks in Obese Adults With Metabolic Syndrome: A Randomized Clinical Trial

This clinical trial explores the impact of intensive lifestyle changes on weight loss and cardiometabolic health in adults who are obese and have metabolic syndrome. Metabolic syndrome is a group of conditions that increase the risk of heart disease and other health problems. The study involves 200 participants who are assigned to two groups: one that follows an intensive lifestyle intervention (ILI) and another that maintains usual lifestyle habits (ULI). This research is important because it aims to find effective ways to reduce weight and improve health outcomes in individuals with metabolic syndrome, potentially leading to new guidelines for managing this condition. Participants in the ILI group are asked to eat only during an 8-hour window and fast for the remaining 16 hours each day, combined with daily physical activity goals such as walking more than 10,000 steps. The study uses mobile apps and wearable devices to track participants' progress. After 24 weeks, participants in both groups receive additional weight control medications for 26 weeks. The effectiveness of these medications, Rybelsus and Forxiga, is evaluated on weight loss and liver fat reduction. Overall, the study measures changes in weight, metabolic health scores, and the sustainability of any improvements over time.