Hongkou Advanced Research on Metabolism and Obesity iNtervention studY (HARMONY): a protocol for a longitudinal cohort study.

Abstract

Obesity is a global chronic metabolic disorder associated with significant comorbidities and healthcare burdens. Nutrient-stimulated hormone (NuSH)-based therapies have markedly advanced the pharmacological treatment for obesity. However, heterogeneity in treatment responses, high discontinuation rates, post-cessation weight regain and concerns regarding long-term safety still remain unresolved. To address these challenges, we initiated the Hongkou Advanced Research on Metabolism and Obesity iNtervention studY (HARMONY), a real-world, prospective observational cohort designed to comprehensively monitor the metabolic responses and clinical outcomes of adults with overweight or obesity undergoing various weight management interventions, with particular attention to the application of NuSH therapy. The HARMONY study is a prospective, observational cohort study to be conducted at Shanghai Fourth People's Hospital, Hongkou district, Shanghai, China. The study will enrol approximately 1500 overweight and obese participants over a 5-year period. Data collection will occur at baseline, week 4, week 12, week 24 and annually thereafter, including anthropometric measures, clinical evaluations, metabolic assessments and treatment outcomes. The primary endpoint is the percentage change in body weight at week 12 and week 24, while secondary endpoints include glucose metabolism, lipid profiles, liver and intrapancreatic fat deposition and safety outcomes such as adverse events. The cohort will be followed longitudinally to assess the long-term impact of weight management interventions. Ethical approval for the study has been granted by the Medical Ethics Committee of Shanghai Fourth People's Hospital (No. 2025036-001). Study findings will be disseminated through peer-reviewed publications and academic conferences, with reporting in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. ChiCTR2500113384.