Efficacy of multilevel exercise programmes with different intensities on development and metabolic homeostasis in overweight and obese children: study protocol for a randomized controlled trial

BackgroundThe prevalence of childhood obesity is rapidly increasing worldwide. Exercise has been suggested as the primary approach to manage body weight, but an effective exercise program tailored for school-age children is still lacking. ObjectiveThis trial aims to evaluate the efficacy of a novel multilevel (children, families, and schools)-coordinated exercise programmes with different intensities on adiposity and development among overweight and obese school-age children. It also aims to elucidate the complex interplays between the exercise interventions, multi-omic biomarkers, development, and metabolic homeostasis. MethodsThis is a multilevel -coordinated two-stage randomized double-blind controlled trial, comprising 366 overweight and obese children aged between 8 and 12 years from two elementary schools in Beijing, China. The novel multilevel exercise programs involve families and schools monitoring childrens exercise and diet via a specially designed smartphone application. The children will be randomly assigned to receive three school-based exercise programmes (exercise intervention stage), namely low-intensity exercise, moderate-intensity exercise, and intermittent vigorous exercise, for 12 weeks, followed by a 9-month post-intervention follow-up (follow-up stage). The primary outcomes of this trial are the changes in adiposity, development, and metabolic homeostasis during the two stages. The secondary outcomes include but are not restricted to genomics and changes in blood metabolomics, gut microbiota, and exercise performance. DiscussionThis trial has been approved by the ethics committee of Peking University Third Hospital (ethnic approval number 2021-283-08). The findings of this trial will help establish specialized multilevel coordinated school-based exercise programmes for overweight and obese school-age children in China and quantitatively and qualitatively evaluate the efficacy of the novel interventions. Trial registrationThis trial was prospectively registered at ClinicalTrials.gov with the identifier of NCT04984005 on July 21, 2021.