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
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
Abstract 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 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. 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.
Liu Yangong、Ren Chuan、Wang Wenxiu、Han Tongyan、Feng Xinheng、Wang Jiaxing、Cui Ligang、Yu Haiyi、Chang Tianqi、Fan Dongwei、Huang He、Fan Chenyu、Liu Chao、Xu Ming、Huang Tao、Zhao Wei、Li Yueying、Wang Hu、Zhao Yimin、Xue Yuzhou、Yao Xiang
Department of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Epidemiology and Biostatistics, School of Public Health, Peking UniversityDepartment of Pediatrics, Peking University Third HospitalDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Ultrasound, Peking University Third HospitalDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Orthopedics, Peking University Third HospitalShanghai Key Laboratory of Metabolic Remodeling and Health, Institute of Metabolism and Integrative BiologyDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Epidemiology and Biostatistics, School of Public Health, Peking UniversityDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third Hospital||Physical Examination Center, Peking University Third HospitalDepartment of Epidemiology and Biostatistics, School of Public Health, Peking UniversityDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalDepartment of Epidemiology and Biostatistics, School of Public Health, Peking UniversityDepartment of Cardiology, Institute of Vascular Medicine, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Peking University Third HospitalSchool of Psychological and Cognitive Sciences, Peking University
医学研究方法预防医学儿科学
Liu Yangong,Ren Chuan,Wang Wenxiu,Han Tongyan,Feng Xinheng,Wang Jiaxing,Cui Ligang,Yu Haiyi,Chang Tianqi,Fan Dongwei,Huang He,Fan Chenyu,Liu Chao,Xu Ming,Huang Tao,Zhao Wei,Li Yueying,Wang Hu,Zhao Yimin,Xue Yuzhou,Yao Xiang.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[EB/OL].(2025-03-28)[2025-05-13].https://www.medrxiv.org/content/10.1101/2023.06.09.23291210.点此复制
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