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Article(id=1325536038508314858, tenantId=1146029695717560320, journalId=1256213402557890569, issueId=1325535161890398372, articleNumber=null, orderNo=null, doi=10.16835/j.cnki.1000-9817.2025370, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1756310400000, receivedDateStr=2025-08-28, revisedDate=1760630400000, revisedDateStr=2025-10-17, acceptedDate=null, acceptedDateStr=null, onlineDate=1793962018848, onlineDateStr=2026-11-06, pubDate=1766592000000, pubDateStr=2025-12-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793962018848, onlineIssueDateStr=2026-11-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793962018848, creator=13701087609, updateTime=1793962018848, updator=13701087609, issue=Issue{id=1325535161890398372, tenantId=1146029695717560320, journalId=1256213402557890569, year='2025', volume='46', issue='12', pageStart='1673', pageEnd='1824', issueExtLink='null', onlineDate='null', pubDate='1766592000000', pubDateStr='2025-12-25', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793961809846, creator='13701087609', updateTime=1793961809846, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1760, endPage=1764, ext={EN=ArticleExt(id=1325536042866196715, articleId=1325536038508314858, tenantId=1146029695717560320, journalId=1256213402557890569, language=EN, title=Status of clinical trial registration for obesity among children and adolescents, columnId=1325500884406379444, journalTitle=Chinese Journal of School Health, columnName=Disease Control, runingTitle=null, highlight=null, articleAbstract=
Objective

To analyze the current status of clinical trial registration for childhood and adolescent obesity, so as to provide insights for the registration and implementation of related trials.

Methods

ClinicalTrials.gov and the ChiCTR database were searched for obesity-related clinical trial registrations up to 1 June 2025. Data included basic characteristics (registration region, date, funding source, status, sample size), trial design features, participant demographics, interventions, outcome measures, methodology, and reporting quality. Statistical and descriptive analyses were conducted.

Results

A total of 1 450 registered studies were included, covering 59 regions globally. North America hosted the highest number of registrations (876, 60.41%), with the United States accounting for the largest share (771, 53.17%). The earliest registered study dated to 1985, while 2016 saw the highest annual registrations (n=87). Funding sources predominantly originated from universities (834 studies, 57.52%). Currently, completed trials accounted for the majority (1 003 trials, 69.17%). Globally, the majority of studies employed sample sizes within the 11-50 range (331 studies, 22.83%). Interventional studies predominated in design type (1 186, 81.79%), predominantly employing randomized parallel-group controlled trials. Main interventions included comprehensive lifestyle interventions, physical activity and exercise interventions, and diet and nutrition interventions. High-frequency outcome indicators primarily involved body composition and anthropometric measurements, metabolic and biochemical indicators, etc. Methodology and reporting quality required improvement.

Conclusions

The registration of clinical trials related to childhood and adolescent obesity globally shows a positive development trend, but issues of regional imbalance and methodological limitations exist. It is necessary to strengthen clinical trial registration norms, optimize study designs, and focus on the innovation of interventions and the systematicity of outcome indicators.

, authors=Chenchen LIANG, Zhongyi ZHU, Haoran ZHANG, Yan YANG*, authorsList=Chenchen LIANG, Zhongyi ZHU, Haoran ZHANG, Yan YANG, authorCompany=null, correspAuthors=Yan YANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2025 Chinese Journal of School Health. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1325536053272264947, articleId=1325536038508314858, tenantId=1146029695717560320, journalId=1256213402557890569, language=CN, title=儿童青少年肥胖临床试验注册现状, columnId=1325500884628677558, journalTitle=中国学校卫生, columnName=疾病控制, runingTitle=null, highlight=null, articleAbstract=
目的

分析儿童青少年肥胖临床试验注册现状，为儿童青少年肥胖相关临床试验注册和实施提供借鉴。

方法

检索ClinicalTrials.gov及ChiCTR自建库至2025年6月1日与儿童青少年肥胖相关的临床试验注册项目，内容包括临床试验的基本特征(注册地区、注册时间、资金来源、注册项目状态、样本量)、临床试验研究特征、研究对象基本特征、干预措施、结果测量、方法学及报告质量等，对数据资料进行描述性分析。

结果

共纳入1 450项注册研究，覆盖全球59个地区；注册项目数最多的大陆为北美洲(876项，60.41%)，最多的国家为美国(771项，53.17%)。首项相关研究注册于1985年，注册项目数最多的年份为2016年(87项)。研究资金来源主要为高校(834项，57.52%)，目前处于完成状态的临床试验项目数共1 003项(69.17%)，全球范围内研究样本量主要在11~50例区间(331项，22.83%)。研究设计类型以干预性研究为主(1 186，81.79%)，设计方案以随机平行对照研究为主。干预措施主要有综合生活方式干预、体育活动与运动干预、饮食与营养干预等，高频结局指标主要为身体成分与人体测量、代谢与生化指标等，对纳入研究的试验质量分析显示其方法学及报告质量有待提升。

结论

全球儿童青少年肥胖相关临床试验注册项目呈良好发展态势，但存在区域不均衡和方法学局限。应加强临床试验注册规范、优化研究设计，重点关注干预措施的创新性和结局指标的系统性。

, authors=梁晨晨, 朱中一, 张昊冉, 杨燕*, authorsList=梁晨晨, 朱中一, 张昊冉, 杨燕, authorCompany=null, correspAuthors=杨燕, authorNote=

梁晨晨(1999-)，女，河南三门峡人，在读硕士，主要研究方向为中医儿科脾胃病方向

, correspAuthorsNote=
杨燕，E-mail:
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梁晨晨(1999-)，女，河南三门峡人，在读硕士，主要研究方向为中医儿科脾胃病方向

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rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=Committee of Guidelines for Childhood Obesity Prevention and Control. Guidelines for childhood obesity and control (2021)[M]. Beijing: People's Medical Publishing House, 2021. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536109538853161, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=2, rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1 698 population-based measurement studies with 19.2 million participants[J]. Lancet, 2016, 387(10026): 1377-1396., articleTitle=null, refAbstract=null), Reference(id=1325536110369325354, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=3, rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=中华人民共和国国务院新闻办公室. 中国居民营养与慢性病状况报告(2020年)[J]. 营养学报, 2020, 42(6): 521., articleTitle=null, refAbstract=null), Reference(id=1325536111166243115, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=3, rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=Information Office of the State Council of the PRC. Report on the nutrition and chronic disease status of Chinese residents[J]. Acta Nutr Sin, 2020, 42(6): 521. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536113271783726, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=4, rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=马冠生, 米杰, 马军, 等. 中国儿童肥胖报告[R]. 北京: 人民卫生出版社, 2017: 12., articleTitle=null, refAbstract=null), Reference(id=1325536114072895791, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=4, rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=MA G S, MI J, MA J, et al. Report on childhood obesity in China[R]. Beijing: People's Medical Publishing House, 2017: 12. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536114605572400, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=5, rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=胡媛媛, 杨丹. 儿童肥胖研究的相关进展[J]. 现代临床医学, 2021, 47(2): 157-160., articleTitle=null, refAbstract=null), Reference(id=1325536115352158513, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=5, rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=HU Y Y, YANG D. Research progress on childhood obesity[J]. J Mod Clin Med, 2021, 47(2): 157-160. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536116136493362, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=6, rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=BORYSOWSKI J, GÓRSKI A. ClinicalTrials. gov as a source of information about expanded access programs: cohort study[J]. J Med Internet Res, 2021, 23(10): e26890., articleTitle=null, refAbstract=null), Reference(id=1325536117860352308, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=7, rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=梅茹梦, 臧凝子, 宫成军, 等. 中医药治疗超重/肥胖的临床试验注册特征分析[J]. 世界科学技术-中医药现代化, 2025, 27(10): 2999-3009., articleTitle=null, refAbstract=null), Reference(id=1325536118355280181, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=7, rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=MEI R M, ZANG N Z, GONG C J, et al. An analysis of clinical trial registration characteristics for traditional Chinese medicine in the treatment of overweight/obesity[J]. Mod Trad Chin Med Mater Med World Sci Technol, 2025, 27(10): 2999-3009. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536119202529590, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=8, rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=ZHANG X, LAN L, CHAN J C P, et al. WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020: recommendations, explanation, and elaboration[J]. BMC Med Res Methodol, 2020, 20(1): 192., articleTitle=null, refAbstract=null), Reference(id=1325536119936532791, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=9, rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=HSIEHCHEN D, ESPINOZA M, HSIEH A. The cooperative landscape of multinational clinical trials[J]. PLoS One, 2015, 10(6): e013 0930., articleTitle=null, refAbstract=null), Reference(id=1325536122079822136, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=10, rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=李琪, 周艺, 丁文琴, 等. 儿童睡眠期间卧室夜间光暴露与体质量指数关联的随访研究[J]. 中国学校卫生, 2024, 45(4): 475-478., articleTitle=null, refAbstract=null), Reference(id=1325536122880934201, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=10, rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=LI Q, ZHOU Y, DING W Q, et al. Follow-up study of the association between bedroom light at night exposure and body mass index in children[J]. Chin J Sch Health, 2024, 45(4): 475-478. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536123363279162, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=11, rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=YUAN C, DONG Y, CHEN H, et al. Determinants of childhood obesity in China[J]. Lancet Public Health, 2024, 9(12): e1105-e1114., articleTitle=null, refAbstract=null), Reference(id=1325536123837235515, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=12, rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=吴泰相, 米娜瓦尔·阿不都, 郝园, 等. 中国临床试验注册10年: 现状与问题[J]. 中国循证医学杂志, 2018, 18(6): 522-525., articleTitle=null, refAbstract=null), Reference(id=1325536124621570364, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=12, rfOrder=18, authorNames=null, journalName=null, refType=null, unstructuredReference=WU T X, MINAWAER A B D, HAO Y, et al. The past 10 years of clinical trial registration in China: status and challenge[J]. Chin J Evid Based Med, 2018, 18(6): 522-525. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536126706139453, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=13, rfOrder=19, authorNames=null, journalName=null, refType=null, unstructuredReference=恽佳欣, 范晶晶, 杨郁. 我国医学期刊遵循临床试验注册制度的现状调查[J]. 编辑学报, 2023, 35(2): 157-164., articleTitle=null, refAbstract=null), Reference(id=1325536127540805950, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=13, rfOrder=20, authorNames=null, journalName=null, refType=null, unstructuredReference=YUN J X, FAN J J, YANG Y. A survey of the current status of Chinese medical journals following the clinical trial registration policies[J]. Acta Editol, 2023, 35(2): 157-164. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536128371278143, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=14, rfOrder=21, authorNames=null, journalName=null, refType=null, unstructuredReference=宓宝来, 杨俏丽, 刘羽飞, 等. 肢体淋巴水肿中国临床试验注册研究现状分析[J]. 中国医刊, 2025, 60(5): 567-572., articleTitle=null, refAbstract=null), Reference(id=1325536129260470592, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=14, rfOrder=22, authorNames=null, journalName=null, refType=null, unstructuredReference=MI B L, YANG Q L, LIU Y F, et al. Analysis on the current situation of clinical trial registration of limb lymphedema in China[J]. Chin J Med, 2025, 60(5): 567-572. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536131189850433, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=15, rfOrder=23, authorNames=null, journalName=null, refType=null, unstructuredReference=DE FIORE L, ADDIS A. Real-world evidence[J]. Recent Prog Med, 2017, 108(12): 497-499., articleTitle=null, refAbstract=null), Reference(id=1325536132162928962, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=16, rfOrder=24, authorNames=null, journalName=null, refType=null, unstructuredReference=付娟娟, 王刚, 毛兵. 中医药随机对照试验中安慰剂应用科学性与伦理性评价[J]. 中国循证医学杂志, 2008, 8(9): 781-785., articleTitle=null, refAbstract=null), Reference(id=1325536132968235331, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=16, rfOrder=25, authorNames=null, journalName=null, refType=null, unstructuredReference=FU J J, WANG G, MAO B. The assessment of scientificalness and ethic of placebo-controlled trials in traditional Chinese medicine[J]. Chin J Evid Based Med, 2008, 8(9): 781-785. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536133840650564, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=17, rfOrder=26, authorNames=null, journalName=null, refType=null, unstructuredReference=林潼, 刘敏. 中医药治疗单纯性肥胖的研究[J]. 中国中医基础医学杂志, 2021, 27(6): 1036-1040., articleTitle=null, refAbstract=null), Reference(id=1325536135178633541, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=17, rfOrder=27, authorNames=null, journalName=null, refType=null, unstructuredReference=LIN T, LIU M. Study on treatment of simple obesity with traditional Chinese medicine[J]. J Basic Chin Med, 2021, 27(6): 1036-1040. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536135958774086, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=18, rfOrder=28, authorNames=null, journalName=null, refType=null, unstructuredReference=邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析[J]. 中国循证心血管医学杂志, 2017, 9(2): 129-134., articleTitle=null, refAbstract=null), Reference(id=1325536136789246279, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=18, rfOrder=29, authorNames=null, journalName=null, refType=null, unstructuredReference=WU L, TIAN G X, WANG X H, et al. Comparative analysis of clinical trial registration and registry platforms[J]. Chin J Evid Based Cardiovasc Med, 2017, 9(2): 129-134. (in Chinese), articleTitle=null, refAbstract=null), Reference(id=1325536137678438728, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=19, rfOrder=30, authorNames=null, journalName=null, refType=null, unstructuredReference=ANAND V, CAHAN A, GHOSH S. Clinical trials. gov: a topical analyses[J]. AMIA Jt Summits Transl Sci Proc, 2017, 2017: 37-47., articleTitle=null, refAbstract=null), Reference(id=1325536138458579273, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=20, rfOrder=31, authorNames=null, journalName=null, refType=null, unstructuredReference=中国临床试验注册中心公告[J]. 中国循证医学杂志, 2007, 7(8): 557-558., articleTitle=null, refAbstract=null), Reference(id=1325536140018860362, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=20, rfOrder=32, authorNames=null, journalName=null, refType=null, unstructuredReference=Statement of Chinese clinical trial register[J]. Chin J Evid Based Med, 2007, 7(8): 557-558. (in Chinese), articleTitle=null, refAbstract=null)], funds=[Fund(id=1325536105327771942, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, awardId=null, language=CN, fundingSource=中华中医药学会标准化项目(20230706-BZ-CACM), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1325536056921309428, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, xref=null, ext=[AuthorCompanyExt(id=1325536056950669557, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, companyId=1325536056921309428, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China), AuthorCompanyExt(id=1325536057005195510, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, companyId=1325536056921309428, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=首都医科大学附属北京儿童医院中医科，北京 100045)])], figs=[ArticleFig(id=1325536090530267417, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=EN, label=Fig.1, caption=Clinical trial registration screening process for childhren and adolescents obesity, figureFileSmall=+aNbuOCANlEYhZmi7C7NBg==, figureFileBig=hM7Nq3YhTcHr5i94qekNvA==, tableContent=null), ArticleFig(id=1325536091939553563, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=CN, label=图1, caption=儿童青少年肥胖临床试验注册筛选流程, figureFileSmall=+aNbuOCANlEYhZmi7C7NBg==, figureFileBig=hM7Nq3YhTcHr5i94qekNvA==, tableContent=null), ArticleFig(id=1325536096066748702, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=EN, label=Fig.2, caption=Annual number of registered clinical trials on children and adolescents obesity from global and China during 1985-2025, figureFileSmall=KeDP6WanepoZAaHwGGw/aw==, figureFileBig=20aStzoZtnvJ131Kz2afFg==, tableContent=null), ArticleFig(id=1325536096926581023, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=CN, label=图2, caption=全球及中国1985—2025年每年儿童青少年肥胖临床试验注册项目数量, figureFileSmall=KeDP6WanepoZAaHwGGw/aw==, figureFileBig=20aStzoZtnvJ131Kz2afFg==, tableContent=null), ArticleFig(id=1325536097794801952, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=EN, label=Fig.3, caption=Sample size distribution of clinical trials among children and adolescents obesity from global and China, figureFileSmall=4gkkWa1jBiqKOpO+kYGJUA==, figureFileBig=Qo+rVfMmcQ5OAnOONSOcwA==, tableContent=null), ArticleFig(id=1325536098906292513, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=CN, label=图3, caption=全球及中国儿童青少年肥胖临床试验注册项目样本量区间分布, figureFileSmall=4gkkWa1jBiqKOpO+kYGJUA==, figureFileBig=Qo+rVfMmcQ5OAnOONSOcwA==, tableContent=null), ArticleFig(id=1325536099770319138, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=EN, label=Tab.1, caption=

Characteristics of registered clinical trials for children and adolescents obesity worldwide

, figureFileSmall=null, figureFileBig=null, tableContent=
注册特征选项项目数构成比/%
研究目的治疗66846.07
预防57839.86
其他684.69
基础医学453.10
支持性护理362.48
卫生服务研究352.41
诊断70.48
筛查60.41
未知70.48
临床试验类型干预性1 18681.79
观察性24616.97
预防性130.90
未知50.34
随机化随机86959.93
非随机1339.17
不适用34123.52
未知1077.38
设计类型平行87660.41
单臂27819.17
交叉815.59
序贯151.03
阶乘80.55
未知19213.24
盲法开放标签38626.62
单盲45831.59
双盲20714.28
三盲1027.03
四盲543.72
未知24316.76
), ArticleFig(id=1325536100684677411, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=CN, label=表1, caption=

全球儿童青少年肥胖临床试验项目注册特征分布

, figureFileSmall=null, figureFileBig=null, tableContent=
注册特征选项项目数构成比/%
研究目的治疗66846.07
预防57839.86
其他684.69
基础医学453.10
支持性护理362.48
卫生服务研究352.41
诊断70.48
筛查60.41
未知70.48
临床试验类型干预性1 18681.79
观察性24616.97
预防性130.90
未知50.34
随机化随机86959.93
非随机1339.17
不适用34123.52
未知1077.38
设计类型平行87660.41
单臂27819.17
交叉815.59
序贯151.03
阶乘80.55
未知19213.24
盲法开放标签38626.62
单盲45831.59
双盲20714.28
三盲1027.03
四盲543.72
未知24316.76
), ArticleFig(id=1325536101502566692, tenantId=1146029695717560320, journalId=1256213402557890569, articleId=1325536038508314858, language=EN, label=Tab.2, caption=

Intervention strategies in registered clinical trials for children and adolescents obesity

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干预类别具体措施数量
综合生活方式生活方式为主的多维干预332
家庭、学校或社区为中心的健康生活方式401
体育活动与运动不同强度及方式的体育、运动训练364
学校及家庭运动计划164
饮食与营养地中海、低碳低盐低脂饮食323
膳食补充剂(维生素、Omega-3脂肪酸、膳食纤维等)94
行为与心理认知疗法、情绪训练126
动机访谈、正念训练56
自我监控、家长行为培训61
技术与远程在线教育、智能远程检测106
穿戴设备(Fitbit智能设备、血糖监测仪)32
医疗与药物减肥药物(利拉鲁肽、二甲双胍)、生长激素28
减肥手术(胃束带术、袖状胃切除术)23
中医耳穴按摩、针灸、中药16
睡眠睡眠延长、规律化、优化睡眠环境73
环境与政策学校食堂改革、健康食品政策36
社区及校园健康活动152
其他特殊嗅觉刺激、脑深部电刺激、马术疗法、艺术疗法11
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干预类别具体措施数量
综合生活方式生活方式为主的多维干预332
家庭、学校或社区为中心的健康生活方式401
体育活动与运动不同强度及方式的体育、运动训练364
学校及家庭运动计划164
饮食与营养地中海、低碳低盐低脂饮食323
膳食补充剂(维生素、Omega-3脂肪酸、膳食纤维等)94
行为与心理认知疗法、情绪训练126
动机访谈、正念训练56
自我监控、家长行为培训61
技术与远程在线教育、智能远程检测106
穿戴设备(Fitbit智能设备、血糖监测仪)32
医疗与药物减肥药物(利拉鲁肽、二甲双胍)、生长激素28
减肥手术(胃束带术、袖状胃切除术)23
中医耳穴按摩、针灸、中药16
睡眠睡眠延长、规律化、优化睡眠环境73
环境与政策学校食堂改革、健康食品政策36
社区及校园健康活动152
其他特殊嗅觉刺激、脑深部电刺激、马术疗法、艺术疗法11
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儿童青少年肥胖临床试验注册现状
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梁晨晨 , 朱中一 , 张昊冉 , 杨燕 *
中国学校卫生 | 疾病控制 2025,46(12): 1760-1764
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中国学校卫生 |疾病控制 2025 , 46 (12) : 1760 -1764
儿童青少年肥胖临床试验注册现状
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梁晨晨, 朱中一, 张昊冉, 杨燕*
作者信息
  • 首都医科大学附属北京儿童医院中医科，北京 100045
通讯作者:
杨燕，E-mail:
作者简介:

梁晨晨(1999-)，女，河南三门峡人，在读硕士，主要研究方向为中医儿科脾胃病方向

Status of clinical trial registration for obesity among children and adolescents
Chenchen LIANG, Zhongyi ZHU, Haoran ZHANG, Yan YANG*
Affiliations
  • Department of Traditional Chinese Medicine, Beijing Children's Hospital, Capital Medical University, Beijing 100045, China
出版时间: 2025-12-25 doi: 10.16835/j.cnki.1000-9817.2025370
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摘要
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目的

分析儿童青少年肥胖临床试验注册现状，为儿童青少年肥胖相关临床试验注册和实施提供借鉴。

方法

检索ClinicalTrials.gov及ChiCTR自建库至2025年6月1日与儿童青少年肥胖相关的临床试验注册项目，内容包括临床试验的基本特征(注册地区、注册时间、资金来源、注册项目状态、样本量)、临床试验研究特征、研究对象基本特征、干预措施、结果测量、方法学及报告质量等，对数据资料进行描述性分析。

结果

共纳入1 450项注册研究，覆盖全球59个地区；注册项目数最多的大陆为北美洲(876项，60.41%)，最多的国家为美国(771项，53.17%)。首项相关研究注册于1985年，注册项目数最多的年份为2016年(87项)。研究资金来源主要为高校(834项，57.52%)，目前处于完成状态的临床试验项目数共1 003项(69.17%)，全球范围内研究样本量主要在11~50例区间(331项，22.83%)。研究设计类型以干预性研究为主(1 186，81.79%)，设计方案以随机平行对照研究为主。干预措施主要有综合生活方式干预、体育活动与运动干预、饮食与营养干预等，高频结局指标主要为身体成分与人体测量、代谢与生化指标等，对纳入研究的试验质量分析显示其方法学及报告质量有待提升。

结论

全球儿童青少年肥胖相关临床试验注册项目呈良好发展态势，但存在区域不均衡和方法学局限。应加强临床试验注册规范、优化研究设计，重点关注干预措施的创新性和结局指标的系统性。

肥胖症  /  临床试验  /  注册  /  儿童  /  青少年
Objective

To analyze the current status of clinical trial registration for childhood and adolescent obesity, so as to provide insights for the registration and implementation of related trials.

Methods

ClinicalTrials.gov and the ChiCTR database were searched for obesity-related clinical trial registrations up to 1 June 2025. Data included basic characteristics (registration region, date, funding source, status, sample size), trial design features, participant demographics, interventions, outcome measures, methodology, and reporting quality. Statistical and descriptive analyses were conducted.

Results

A total of 1 450 registered studies were included, covering 59 regions globally. North America hosted the highest number of registrations (876, 60.41%), with the United States accounting for the largest share (771, 53.17%). The earliest registered study dated to 1985, while 2016 saw the highest annual registrations (n=87). Funding sources predominantly originated from universities (834 studies, 57.52%). Currently, completed trials accounted for the majority (1 003 trials, 69.17%). Globally, the majority of studies employed sample sizes within the 11-50 range (331 studies, 22.83%). Interventional studies predominated in design type (1 186, 81.79%), predominantly employing randomized parallel-group controlled trials. Main interventions included comprehensive lifestyle interventions, physical activity and exercise interventions, and diet and nutrition interventions. High-frequency outcome indicators primarily involved body composition and anthropometric measurements, metabolic and biochemical indicators, etc. Methodology and reporting quality required improvement.

Conclusions

The registration of clinical trials related to childhood and adolescent obesity globally shows a positive development trend, but issues of regional imbalance and methodological limitations exist. It is necessary to strengthen clinical trial registration norms, optimize study designs, and focus on the innovation of interventions and the systematicity of outcome indicators.

Obesity  /  Clinical trial  /  Registration  /  Child  /  Adolescent
梁晨晨, 朱中一, 张昊冉, 杨燕. 儿童青少年肥胖临床试验注册现状. 中国学校卫生, 2025 , 46 (12) : 1760 -1764 . DOI: 10.16835/j.cnki.1000-9817.2025370
Chenchen LIANG, Zhongyi ZHU, Haoran ZHANG, Yan YANG. Status of clinical trial registration for obesity among children and adolescents[J]. Chinese Journal of School Health, 2025 , 46 (12) : 1760 -1764 . DOI: 10.16835/j.cnki.1000-9817.2025370
正文
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肥胖是指由遗传、环境、行为等多因素导致能量摄入超过能量消耗，身体脂肪蓄积过多，危害健康的一种慢性代谢性疾病[1]。2016年《柳叶刀》的一项调查报告显示，我国肥胖人口数量已跃居世界首位[2]。更令人担忧的是，我国儿童青少年超重肥胖问题日益突出，国内6~17岁儿童青少年群体超重肥胖率达19%[3]，且呈逐年增长趋势，已成为严峻的公共卫生挑战[4]。儿童青少年时期的肥胖大多可延续至成年阶段，不仅直接影响儿童青少年的生长发育进程，还是精神健康、心血管、内分泌、呼吸道等诸多系统疾患的高危因素[5]，对儿童青少年的身心健康造成全方位、深层次的负面影响。
目前，儿童青少年肥胖的治疗方案差异较大，现存的小样本临床观察研究亦缺乏高质量依据[6]。随着临床试验的迅速发展，规范的临床试验注册及研究逐渐受到重视。虽然国内外关于成人肥胖的临床试验注册研究颇多[7]，但儿童青少年具有特殊的生长发育特点，成人肥胖研究结论难以直接适用。本文基于ChiCTR和ClinicalTrials.gov两大注册平台，对儿童青少年肥胖相关临床试验注册情况进行总结与分析，以推动肥胖临床试验的规范化设计和实施，为未来研究提供思路与参考，助力儿童青少年肥胖的防治。
1　资料来源与方法
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1.1　资料来源
在ChiCTR(https://www.chictr.org.cn)及ClinicalTrials.gov(https://clinicaltrials.gov/)中检索关于儿童青少年肥胖的临床试验，检索时间范围为自建库至2025年6月1日。关键词分别为“children”“adolescent”“obesity”“overweight”“儿童”“青少年”“肥胖”“超重”等。纳入标准：儿童青少年肥胖相关临床试验，不限制注册状态、研究类型、注册语言、注册国家、资金来源、招募情况等。排除标准：(1)年龄不符的成人试验；(2)信息不全影响统计分析的试验；(3)注册时无知情同意及伦理未获批准的试验；(4)注册信息有误、已终止或被撤销的试验。
1.2　方法
由2名研究者独立根据纳入与排除标准筛选已注册的临床试验，汇总提取资料、交叉核对，若出现分歧则由其他人员讨论后达成共识。使用Excel 2019软件进行资料录入，提取内容包括以下两个方面：(1)注册试验的基本信息，包括注册题目、注册地区、注册时间、资金来源、项目状态、注册样本量、试验基本特征、纳入对象基本特征、干预措施、结局指标；(2)研究设计信息，包括研究目的、研究类型、研究设计方案及盲法等。
1.3　质量控制
使用来源于世界卫生组织试验注册数据集[8](trial registration data set，TRDS)最低20项标准评估临床试验注册质量。该标准是国际公认的评估临床试验注册完整性与透明度的权威框架，保证了评估的内容效度。在评估过程中，为确保信度，由2名研究人员独立评估、交叉验证。对评估分歧邀请其他人员仲裁，确保评分标准的一致性和评估结果的客观性。
1.4　统计学分析
采用Excel 2019软件对提取的数据资料进行描述性分析，计数资料采用频数、百分比进行统计描述。
2　结果
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2.1　临床试验注册筛选流程
经检索，ChiCTR共获得23项已注册的临床试验项目，ClinicalTrials.gov获得2 036项。经筛选，最终共纳入1 450项已注册的临床试验项目。见图1。
2.2　儿童青少年肥胖临床试验分布特征
2.2.1　注册地区分布
经统计，1 450项儿童青少年肥胖临床试验分布在全球59个地区(若存在多个实施地区时，按注册机构所在地统计该项目注册地区[9])。注册项目最多的3个大洲依次是北美洲(876项，60.41%)、欧洲(331项，22.83%)、亚洲(191项，13.17%), 分布最多的5个国家依次是美国(771项，53.17%)、加拿大(73项，5.03%)、中国(71项，4.90%)、西班牙(53项，3.66%)、法国(37项，2.55%)。国内注册项目数最多的地区分别是上海、北京，各12项(16.90%)，其余依次为台湾、广东(各8项，11.27%)，浙江(6项，8.45%)，湖北和江苏(各4项，5.63%)，河南、辽宁、重庆(各2项，2.82%)，山东以及四川(各1项，1.41%)；剩余9项未标明具体省份。
2.2.2　注册时间分布
首个儿童青少年肥胖试验项目由Augusta University在1985年注册于美国(注册号：NCT00005179)，国内首个相关临床试验项目注册于1999年(注册号：NCT03217656)。总体来看，全球注册数量自2003年起持续增长，在波动中于2016年达到峰值(87项)。中国注册项目自2008年起开始增长，此后处于波动状态，于2022年达到高峰(12项)。见图2。
2.2.3　注册项目资金来源
全球1 450项儿童青少年肥胖临床试验中注册资金来源广泛，主要来源于高校(834项，57.52%)、医院(379项，26.14%)、研究机构(112项，7.72%)、公司/企业(46项，3.17%)、政府机构(37项，2.55%)、个人/自筹(25项，1.72%)、其他(17项，1.17%)。
2.2.4　注册项目状态
临床注册试验项目的状态可分为已完成(全球：1 003项，69.17%；中国：30项，42.25%)、招募中(全球：218项，15.03%；中国：21项，29.58%)、进行中(全球：31项，2.14%；中国：8项，11.27%)、尚未招募(全球：55项，3.79%；中国：4项，5.63%)和未知(全球：143项，9.86%；中国：8项，11.27%)。
2.2.5　注册样本量
全球与国内开展的临床试验样本量大致相同，主要集中于11~200区间。其中全球范围内样本量在11~50区间的项目数最多，共331项(22.83%)；国内样本量在51~100区间的项目数最多，共19项(26.76%)。见图3。
2.3　儿童青少年肥胖临床试验注册特征
1 450项临床试验中，治疗性研究占比最高(668项，46.07%)，以干预性(1 186项，81.79%)、随机化(869项，59.93%)、平行设计(876项，60.41%)、单盲(458项，31.59%)研究为主。见表1。
2.4　儿童青少年肥胖临床注册试验研究纳入对象的基本特征
年龄方面，全球范围内纳入的研究对象中最小年龄段为新生儿和婴儿(117项，8.07%)，其次是5~10岁(814项，56.14%)，较大年龄段为17~18(482项，33.24%)和11~12岁(259项，17.86%)。研究疾病方面，共1 084项临床试验包含了对相关疾病并发疾的研究，常见合并疾病前5项分别是2型糖尿病(154项，14.21%)、非酒精性脂肪肝(137项，12.64%)、胰岛素抵抗(122项，11.25%)、高胆固醇血症(101项，9.32%)、高胰岛素血症(95项，8.76%)。
2.5　儿童青少年肥胖临床试验注册的干预措施
在儿童青少年肥胖的干预性研究中，各类干预措施可分为9类：综合生活方式干预、体育活动与运动干预、饮食与营养干预、行为与心理干预、技术与远程干预、医疗与药物干预、睡眠干预、环境与政策干预、其他特殊干预。见表2。
2.6　儿童青少年肥胖临床试验注册项目结果指标
在儿童青少年肥胖相关临床试验中，常见的结果测量指标依次是：身体成分与人体测量(如体质量指数、体脂率、腰围等)共1 039项、代谢与生化指标(胰岛素抵抗、血脂、炎症标志物等)共650项、饮食与营养摄入(能量、蔬果、含糖饮料等)共632项、心血管与呼吸功能(血压、心肺功能等)共468项、心理健康与行为346项、活动与运动能力294项、家长与家庭因素268项、睡眠情况113项、肠道微生物与免疫110项，以及神经认知与脑功能87项和其他特殊指标68项。
2.7　儿童青少年肥胖方法学质量
在纳入的1 450项临床试验中，随机平行对照试验共851项(58.69%)。其中频次最高的依次是简单随机(296项，34.78%)、区组随机(263项，30.90%)、分层随机(143项，16.80%)、整群随机(62项，7.29%)、分层区组随机(19项，2.23%)、中央随机(12项，1.41%)和未说明(56项，6.58%)。盲法方面，单盲试验最多，共458项(31.59%)，主要对受试者或评估者设盲；双盲试验207项(14.28%)，侧重于对统计分析者或受试者与评估者设盲；三盲和四盲试验分别有102(7.03%)和54项(3.72%)，涉及更多角色的盲法控制。此外，386项试验(26.62%)未使用任何盲法，243项(16.76%)未报告盲法实施情况。
2.8　儿童青少年肥胖报告质量
在纳入的1 450项临床试验中，所有研究均具备独立注册编号和注册时间，核心信息如研究负责人、标题、研究内容、计划等登记较为全面。实施细节的报告完整度存在差异：986项(68.00%)详细描述干预措施，863项(59.52%)注明主要结局指标的评估时间，661项(45.59%)报告次要结局指标的评估时间，仅432项(29.79%)具体说明结局指标的测量方法。
3　讨论
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3.1　ChiCTR与ClinicalTrials.gov存在较大差距
临床试验注册作为提升研究透明化的重要举措[10]，有利于保障临床研究的质量、增加研究过程的规范性和研究结果的可信度[11]，在我国也逐渐得到重视。但在对儿童青少年肥胖临床试验注册的统计中发现，国内的注册数量非常有限。可能与ChiCTR正式运行时间较晚，研究者对临床试验注册的认识和重视不足[12]，国内期刊对试验注册号和医学伦理审查的要求非强制、影响注册试验的推广和规范[13]等有关。为缩小差距，应加强对规范临床试验的认识，提升研究的整体质量及国际可见度。
3.2　临床试验注册基本特征
在地区分布方面，绝大多数临床试验集中在北美及西欧等地的国家，占据了全球数量的80%以上，而疾病负担较重的发展中国家临床试验仅占不足20%，凸显出全球健康领域在资源分配、科研能力等方面的巨大差异。中国作为最大的发展中国家，试验注册数量居全球第三，展现出一定的科研实力与发展潜力。但国内地区分布同样存在差异，北京、上海、广东、台湾的注册数量占比高达近60%，江南、沿海及中原地区次之，西部地区仅四川省注册了1项临床试验。这种分布格局与国内研究单位分布集中，北京、上海、广州科研基础扎实，经济发展较好，经费投入充足有关[14]。提示应加强中西部地区的科研建设，推动更具代表性的研究布局、弥补地域差距，同时推动全球健康公平、提升儿童肥胖防控能力。
从时间发展来看，全球儿童青少年肥胖临床试验经历了从萌芽、快速发展到受疫情影响波动恢复的过程，而我国起步较晚、发展存在断层，直至近年才实现显著突破。这一动态变化反映出临床试验受全球公共卫生事件、科研投入和政策重点的显著影响，应加强该领域的长期科研布局及面对突发公共卫生事件的应对措施。
从注册状态来看，中国整体进展与全球同步，但“进行中”项目的占比高于其他状态，反映出我国正积极推进该类临床试验的实施，研究活跃度较高，但也反映出部分项目可能存在推进缓慢、结果产出有待提升的问题。
在样本量方面，中国与全球研究均显示超过60%的试验样本量低于300例；国际研究更集中于11~50例的小样本设计，国内研究更常见51~100例的中等规模。全球均缺乏大样本、多中心临床试验，限制了儿童青少年肥胖干预措施效果的整体评估。未来可通过组建跨国研究联盟、完善多中心协作机制、加大经费投入等措施，优先推动大规模国际合作研究，共同助力防治青少年肥胖。
3.3　临床试验内容信息
通过对纳入的临床试验注册特征统计发现，试验研究目的以治疗为主，预防性研究次之；在研究类型方面，干预性研究为主导，其中随机平行对照试验最常见。作为临床研究的金标准，随机平行对照试验能够有效建立因果关系，减少偏倚并准确评估干预措施的有效性[15]。高质量的随机对照设计应尽可能地使用受试者和研究者盲法，以减少选择性和测量偏倚[16]。然而统计发现，仅56.62%(821项)的研究明确采用了盲法设计，且以单盲为主，反映出研究者对设盲的重视和实施仍有不足。规范的试验方案是确保研究质量的关键基础，只有通过严谨设计获得的研究结论才能为临床实践提供可靠依据[17]。应更加重视包括盲法在内的试验设计规范，确保提供坚实可靠的科学证据。
在干预措施方面，综合生活方式干预占据主导地位，体育活动与运动干预及饮食与营养干预次之。近年来行为与心理干预及技术与远程干预呈现上升趋势，而医疗与药物干预因儿童用药限制，注册项目相对有限。其中睡眠干预、医疗与生物干预中的中医药疗法等措施，也展现其对肥胖防治的独特优势[18-19]。从干预措施可看出近年来多维度的体重管理趋势，对心理健康及研究效率的重视及干预理念的转变，为临床防治儿童青少年肥胖提供了多角度思路，也为未来的研究方向提供了指引。结局指标的分布反映了当前研究重点关注生理与代谢指标，同时逐步纳入心理、行为、家庭及睡眠等多维度因素，表明肥胖干预研究正从传统医学模式向“生物—心理—社会”综合模式转变。因此，在未来研究中应更注重整体健康视角，兼顾多系统结局指标，以全面评估干预措施的有效性。
本研究也存在一定的局限性：(1)尽管使用核心关键词进行检索，但仍无法穷尽其他相关术语及同义词，可能导致部分相关试验被遗漏，对整体分析结果的全面性产生一定影响。(2)中外合作研究普遍倾向于在ClinicalTrials.gov注册，可能未在ChiCTR同步登记，导致本研究可能对此类试验的统计有所偏差，也导致在呈现全球科研合作全貌时的不准确性。
随着我国儿童青少年肥胖率增长迅速，低龄化趋势日益严峻，相关临床试验数量显著增加。本文揭示了全球科研资源分布的不均衡性、广大发展中国家面临的证据缺口及现阶段临床试验存在的质量问题。我国临床试验注册体系建设起步较晚，但在科研投入持续加大的背景下正快速发展[20]。今后在开展众多临床试验的同时还应注重试验质量，对儿童青少年肥胖的干预应从单纯的体重控制转向多维度干预，重视心理行为、社会环境的综合作用，为儿童青少年肥胖的精准防控提供有力支撑，最终实现青少年健康水平的整体提升。
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  • 中华中医药学会标准化项目(20230706-BZ-CACM)
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参考文献 引证文献
排序方式：
1
儿童肥胖预防与控制指南修订委员会. 儿童肥胖与控制指南(2021)[M]. 北京: 人民卫生出版社, 2021.
Committee of Guidelines for Childhood Obesity Prevention and Control. Guidelines for childhood obesity and control (2021)[M]. Beijing: People's Medical Publishing House, 2021. (in Chinese)
2
NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1 698 population-based measurement studies with 19.2 million participants[J]. Lancet, 2016, 387(10026): 1377-1396.
3
中华人民共和国国务院新闻办公室. 中国居民营养与慢性病状况报告(2020年)[J]. 营养学报, 2020, 42(6): 521.
Information Office of the State Council of the PRC. Report on the nutrition and chronic disease status of Chinese residents[J]. Acta Nutr Sin, 2020, 42(6): 521. (in Chinese)
4
马冠生, 米杰, 马军, 等. 中国儿童肥胖报告[R]. 北京: 人民卫生出版社, 2017: 12.
MA G S, MI J, MA J, et al. Report on childhood obesity in China[R]. Beijing: People's Medical Publishing House, 2017: 12. (in Chinese)
5
胡媛媛, 杨丹. 儿童肥胖研究的相关进展[J]. 现代临床医学, 2021, 47(2): 157-160.
HU Y Y, YANG D. Research progress on childhood obesity[J]. J Mod Clin Med, 2021, 47(2): 157-160. (in Chinese)
6
BORYSOWSKI J, GÓRSKI A. ClinicalTrials. gov as a source of information about expanded access programs: cohort study[J]. J Med Internet Res, 2021, 23(10): e26890.
7
梅茹梦, 臧凝子, 宫成军, 等. 中医药治疗超重/肥胖的临床试验注册特征分析[J]. 世界科学技术-中医药现代化, 2025, 27(10): 2999-3009.
MEI R M, ZANG N Z, GONG C J, et al. An analysis of clinical trial registration characteristics for traditional Chinese medicine in the treatment of overweight/obesity[J]. Mod Trad Chin Med Mater Med World Sci Technol, 2025, 27(10): 2999-3009. (in Chinese)
8
ZHANG X, LAN L, CHAN J C P, et al. WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020: recommendations, explanation, and elaboration[J]. BMC Med Res Methodol, 2020, 20(1): 192.
9
HSIEHCHEN D, ESPINOZA M, HSIEH A. The cooperative landscape of multinational clinical trials[J]. PLoS One, 2015, 10(6): e013 0930.
10
李琪, 周艺, 丁文琴, 等. 儿童睡眠期间卧室夜间光暴露与体质量指数关联的随访研究[J]. 中国学校卫生, 2024, 45(4): 475-478.
LI Q, ZHOU Y, DING W Q, et al. Follow-up study of the association between bedroom light at night exposure and body mass index in children[J]. Chin J Sch Health, 2024, 45(4): 475-478. (in Chinese)
11
YUAN C, DONG Y, CHEN H, et al. Determinants of childhood obesity in China[J]. Lancet Public Health, 2024, 9(12): e1105-e1114.
12
吴泰相, 米娜瓦尔·阿不都, 郝园, 等. 中国临床试验注册10年: 现状与问题[J]. 中国循证医学杂志, 2018, 18(6): 522-525.
WU T X, MINAWAER A B D, HAO Y, et al. The past 10 years of clinical trial registration in China: status and challenge[J]. Chin J Evid Based Med, 2018, 18(6): 522-525. (in Chinese)
13
恽佳欣, 范晶晶, 杨郁. 我国医学期刊遵循临床试验注册制度的现状调查[J]. 编辑学报, 2023, 35(2): 157-164.
YUN J X, FAN J J, YANG Y. A survey of the current status of Chinese medical journals following the clinical trial registration policies[J]. Acta Editol, 2023, 35(2): 157-164. (in Chinese)
14
宓宝来, 杨俏丽, 刘羽飞, 等. 肢体淋巴水肿中国临床试验注册研究现状分析[J]. 中国医刊, 2025, 60(5): 567-572.
MI B L, YANG Q L, LIU Y F, et al. Analysis on the current situation of clinical trial registration of limb lymphedema in China[J]. Chin J Med, 2025, 60(5): 567-572. (in Chinese)
15
DE FIORE L, ADDIS A. Real-world evidence[J]. Recent Prog Med, 2017, 108(12): 497-499.
16
付娟娟, 王刚, 毛兵. 中医药随机对照试验中安慰剂应用科学性与伦理性评价[J]. 中国循证医学杂志, 2008, 8(9): 781-785.
FU J J, WANG G, MAO B. The assessment of scientificalness and ethic of placebo-controlled trials in traditional Chinese medicine[J]. Chin J Evid Based Med, 2008, 8(9): 781-785. (in Chinese)
17
林潼, 刘敏. 中医药治疗单纯性肥胖的研究[J]. 中国中医基础医学杂志, 2021, 27(6): 1036-1040.
LIN T, LIU M. Study on treatment of simple obesity with traditional Chinese medicine[J]. J Basic Chin Med, 2021, 27(6): 1036-1040. (in Chinese)
18
邬兰, 田国祥, 王行环, 等. 临床试验的注册及注册平台比较分析[J]. 中国循证心血管医学杂志, 2017, 9(2): 129-134.
WU L, TIAN G X, WANG X H, et al. Comparative analysis of clinical trial registration and registry platforms[J]. Chin J Evid Based Cardiovasc Med, 2017, 9(2): 129-134. (in Chinese)
19
ANAND V, CAHAN A, GHOSH S. Clinical trials. gov: a topical analyses[J]. AMIA Jt Summits Transl Sci Proc, 2017, 2017: 37-47.
20
中国临床试验注册中心公告[J]. 中国循证医学杂志, 2007, 7(8): 557-558.
Statement of Chinese clinical trial register[J]. Chin J Evid Based Med, 2007, 7(8): 557-558. (in Chinese)
2025年第46卷第12期
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doi: 10.16835/j.cnki.1000-9817.2025370
  • 接收时间：2025-08-28
  • 首发时间：2026-11-06
  • 出版时间：2025-12-25
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  • 收稿日期：2025-08-28
  • 修回日期：2025-10-17
基金
中华中医药学会标准化项目(20230706-BZ-CACM)
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    首都医科大学附属北京儿童医院中医科，北京 100045

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