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

Background The 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. Objective This 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. Methods This 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 children’s 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. Discussion This 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 registration This trial was prospectively registered at ClinicalTrials.gov with the identifier of [NCT04984005][1] on July 21, 2021. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04984005 ### Funding Statement National Key Research and Development Program (grant numbers: 2020YFA0803803 and 2020YFA0803800) and CAMS Innovation Fund for Medical Sciences (grant number: 2021-I2M-5-003). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee/IRB of Peking University Third Hospital gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04984005&atom=%2Fmedrxiv%2Fearly%2F2023%2F06%2F13%2F2023.06.09.23291210.atom