Exploring Cardiometabolic Health, Physical Activity, and Quality of Life in Patients with Obesity and Multimorbidity during an Intensive Weight Loss Program: A Protocol for a Real-Life Prospective Cohort Study.

BackgroundObesity is associated with increased risk of morbidity, reduced quality of life, and pervasive weight stigma. For patients with severe obesity and multimorbidity who are ineligible for bariatric surgery, effective treatment options remain limited. Recently, glucagon-like peptide 1 receptor agonist-based weight loss medications have shown promise in weight management, but their effects in highly complex patient populations are not well described. ObjectiveThis protocol outlines a prospective observational study designed to explore and describe changes in cardiometabolic health, physical activity, physical capacity, and wellbeing among patients with obesity and multimorbidity enrolled in a two-year intensive weight loss program with GLP-1RA medication. MethodsThe study uses an exploratory prospective longitudinal cohort design and is based on an intensive weight loss program for patients with obesity and multimorbidity at Copenhagen University Hospital - Hvidovre. Approximately 35 patients will be enrolled over a six-month period. Data are collected at baseline, four months, and 24 months. Key outcomes include objectively measured physical activity, health-related quality of life, and 10-year cardiovascular risk. Additional outcomes include anthropometrics, mental health-related quality of life, weight bias internalization, cardiorespiratory fitness, lower body strength, and walking capacity. Data will be analyzed descriptively, and changes will be reported as mean differences with 95% confidence intervals. The study was registered at clinicaltrials.gov prior to recruitment (NCT06234111). PerspectiveThis study will provide novel insights into the health effects of intensive GLP-1RA-based weight loss program for patients with severe obesity and multimorbidity ineligible for bariatric surgery, thereby addressing an important knowledge gap in obesity management. Trial RegistrationThe study has been pre-registered with clinicaltrials.gov prior to inclusion of the first participant (NCT06234111). Project groupO_ST_ABSSemPAct project groupC_ST_ABSRasmus H. Brodsgaard (principal investigator), Thomas Bandholm, Kirstine N. Bojsen-Moller, Carsten Dirksen, Jeanette W. Kirk, Mette M. Pedersen, Sara O. Hofmann, Emilie S. Larsen, Minna Titika Finken, and Olivia M. Duun.