Effect of Lifestyle Modifications in Overweight and Obese Subjects with Metabolic Syndrome: Study Protocol for A Randomized Clinical Trial.

Abstract

The increasing global burden of overweight/obesity and metabolic syndrome (MetS), driven by unhealthy lifestyles, elevates the risk of type 2 diabetes and cardiovascular disease. This randomized, parallel-group study will assess the impact of lifestyle modification (diet and/or exercise) on metabolic syndrome (MetS) in 120 overweight/obese adults (BMI 25-34.9 kg/m², aged 20-70) with at least three MetS components. Participants will be randomized to either treatment as usual (TAU), or TAU + exercise, or TAU + controlled diet, or TAU + exercise + diet. The primary outcome is body weight change after 12 weeks. Secondary outcomes include changes in metabolic parameters (HOMA-IR, BMI, waist/hip circumference, glucose, lipids, blood pressure, AIP, TyG index), perceived stress, sleep quality, and quality of life, assessed over four visits. Statistical analysis will determine the effectiveness of these lifestyle interventions in managing weight and metabolic health in this population. This study aims to provide evidence for effective strategies to combat the growing impact of MetS and also addresses the elevated treatment costs for metabolic syndrome.