"Background: Obesity is a global public health issue, which is associated with higher prevalence of various complications. Individuals with overweight or obesity experience not only physical, but also psychological, emotional, social problems. Traditional Chinese medicine (TCM) may have a potential in obesity management. Xiaogao Jiangzhuo Method (XJM) is an empirical traditional Chinese prescription for weight loss. Recently social work is increasingly participated in clinical practice. The effects of XJM combined with social work in overweight or obesity are not established.
Objectives: This study is designed to propose a response adaptive randomized controlled trial to explore the effectiveness and safety of XJM combined with social work intervention on overweight or obesity.
Methods: This is a response adaptive randomized (RAR) controlled clinical trial performed for 12 weeks in a single center. The study will enroll 32 participants with overweight or obesity aged between 18 to 60. During the first stage, 8 participants will be randomly assigned to the treatment or control groups (1:1), and the unknown parameters are estimated according to the accrual of outcomes. At the second stage, every next participant will be assigned with the updated allocation proportion determined by the allocation function as the response accumulation. The treatment group will receive XJM and social work intervention for 12 weeks, while the control will only receive the XJM therapy. The primary outcome is the percentage change in weight from baseline to week 12. Waist-to-hip ratio, blood lipid, blood glucose, uric acid, insulin levels, Liver and gallbladder ultrasound, dietary questionare, phlegm-heat syndrome scale, psychological outcomes and so on will be assessed. The safety outcome will include all adverse events occurring in the course of the study.
Results: The results are expected to confirm the effectiveness and safety of XJM combined with social work intervention in individuals with overweight or obesity.
Conclusions: This study will explore the chronic disease management strategies for overweight or obesity, providing clinical evidence for the application of TCM combined with social work intervention. "