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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

An Intervention Incorporating Home-School-Medical Collaboration and Digital Meal Planning for Overweight and Obesity in School-Aged Children

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注册号：

Registration number：

ChiCTR2500110731 

最近更新日期：

Date of Last Refreshed on：

2025-10-20 11:50:11 

注册时间：

Date of Registration：

2025-10-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于“家-校-医”融合和数字化配餐的学龄儿童超重肥胖的干预研究

Public title：

An Intervention Incorporating Home-School-Medical Collaboration and Digital Meal Planning for Overweight and Obesity in School-Aged Children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“家-校-医”融合和数字化配餐的学龄儿童超重肥胖的干预研究

Scientific title：

An Intervention Incorporating Home-School-Medical Collaboration and Digital Meal Planning for Overweight and Obesity in School-Aged Children

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

袁家琳 

研究负责人：

朱艳娜 

Applicant：

Jialin Yuan 

Study leader：

Yanna Zhu 

申请注册联系人电话：

Applicant telephone：

+86 156 7477 0845

研究负责人电话：

Study leader's telephone：

+86 136 3240 7152

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

yuanjlin@mail2.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

zhuyn3@mail.sysu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://sph.sysu.edu.cn/teacher/468

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://sph.sysu.edu.cn/teacher/468

申请注册联系人通讯地址：

广东省广州市越秀区中山二路74号中山大学北校园公共卫生学院

研究负责人通讯地址：

广东省广州市越秀区中山二路74号中山大学北校园公共卫生学院

Applicant address：

School of Public Health, North Campus, Sun Yat-sen University, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong Province

Study leader's address：

School of Public Health, North Campus, Sun Yat-sen University, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong Province

申请注册联系人邮政编码：

Applicant postcode：

510080

研究负责人邮政编码：

Study leader's postcode：

510080

申请人所在单位：

中山大学公共卫生学院

Applicant's institution：

School of Public Health, Sun Yat-sen University

研究负责人所在单位：

中山大学公共卫生学院

Affiliation of the Leader：

School of Public Health, Sun Yat-sen University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

中大公卫医伦 (2025) 第 120 号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中山大学公共卫生学院生物医学研究伦理审查委员会

Name of the ethic committee：

Ethics Review Committee for Biomedical Research, School of Public Health, Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-09-15 00:00:00

伦理委员会联系人：

丁莹

Contact Name of the ethic committee：

Ying Ding

伦理委员会联系地址：

广东省广州市越秀区中山二路74号中山大学北校园公共卫生学院

Contact Address of the ethic committee：

School of Public Health, North Campus, Sun Yat-sen University, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8733 5447

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中山大学公共卫生学院

Primary sponsor：

Sun Yat-sen University School of Public Health

研究实施负责（组长）单位地址：

广东省广州市越秀区中山二路74号中山大学北校园公共卫生学院

Primary sponsor's address：

School of Public Health, North Campus, Sun Yat-sen University, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guang Dong

City：

单位(医院)：

中山大学公共卫生学院

具体地址：

广东省广州市越秀区中山二路74号中山大学北校园公共卫生学院

Institution
hospital：

Sun Yat-sen University School of Public Health

Address：

School of Public Health, North Campus, Sun Yat-sen University, No. 74, Zhongshan 2nd Road, Yuexiu District, Guangzhou City, Guangdong Province

经费或物资来源：

广东省自然面上项目

Source(s) of funding：

Natural Science Foundation Project of Guangdong Province

Target disease：

Overweight and obesity

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

1.开发学龄儿童岭南特色配餐指南和食谱； 2.评价基于“家-校-医”融合和数字化配餐的干预策略对学龄儿童超重肥胖的干预效果； 3.建立学龄儿童岭南特色平衡膳食指数量化岭南特色平衡膳食模式与儿童超重肥胖之间的关联。  

Objectives of Study：

1. Develop a Lingnan-style meal planning guide and recipes tailored for school-age children; 2. Evaluate the effectiveness of intervention strategies integrating home-school-clinic collaboration and digital meal planning on overweight and obesity among school-age children; 3. Establish a Lingnan-style balanced diet index to quantify the association between Lingnan-style balanced dietary patterns and childhood overweight/obesity.

药物成份或治疗方案详述：

本研究拟开发6~17岁学龄儿童岭南特色配餐指南和食谱，包括标准食谱、减重食谱等。通过整合岭南特色学龄儿童带量减重食谱、人工智能算法、智能烹饪设备及数字化营养管理平台，构建“家-校-医”融合的儿童肥胖干预新模式，从而实现个性化饮食管理、三方协同干预及动态监测。此外，本研究将通过整群随机对照干预试验，评价基于“家-校-医”融合和数字化配餐的干预策略对7~11岁学龄儿童超重肥胖以及知信行、营养素养、体格、饮食和食欲、运动和生理、肠道菌群组成和血清代谢物水平等指标的影响，探索此干预策略改善学龄儿童超重肥胖及相关体格生理指标的机制。研究将为学龄儿童超重肥胖防控提供创新性解决方案。 

Description for medicine or protocol of treatment in detail：

This study aims to develop Lingnan-specific meal guidelines and recipes for school-aged children aged 6–17, including standard recipes and weight-loss recipes. By integrating Lingnan-specific portion-controlled weight-loss recipes for school-aged children, artificial intelligence algorithms, smart cooking devices, and a digital nutrition management platform, we will establish a new integrated "home-school-clinic" model for childhood obesity intervention. This approach enables personalized dietary management, tripartite collaborative intervention, and dynamic monitoring. Furthermore, this study will conduct a cluster randomized controlled intervention trial to evaluate the effectiveness of the integrated "home-school-clinic" approach and digital meal planning strategy in reducing overweight and obesity to evaluate the impact of this integrated "home-school-clinic" and digital meal planning intervention strategy on indicators such as overweight/obesity, knowledge-attitude-behavior (KAB), nutritional literacy, physical characteristics, dietary habits and appetite, physical activity and physiology, gut microbiota composition, and serum metabolite levels among 7- to 11-year-old school-aged children. It will explore the mechanisms through which this intervention improves overweight/obesity and related physical and physiological indicators in school-aged children. This research will provide innovative solutions for preventing and controlling overweight and obesity among school-aged children. 

纳入标准：

1.学校纳入排除标准及数量 在广州市以学校食堂供餐的公立小学中随机选取5所符合条件的小学，随机分配到5组，其中4所为干预组，1所为对照组。 纳入标准：①公立小学；②以学校食堂为供餐方式；③学校在校学生人数不少于1000人，以确保有足够的超重肥胖儿童符合纳入标准；④学校愿意配合研究团队开展配餐干预及相关数据收集工作。 2.学生纳入排除标准及数量 结合广州市中小学生年度体质健康测试工作，对入选学校的所有学生进行体重、身高等体格指标的测量，依据中国肥胖工作组2018年制定的《中国学龄儿童少年超重肥胖筛查BMI分类标准》，初步筛选出超重肥胖的儿童。对初步筛选出的超重肥胖儿童进行进一步问卷调查，调查其在学校食堂的进餐情况、是否合并基础疾病等，进一步筛选出在学校食堂吃午餐、在家吃早晚餐的符合纳入标准的儿童，询问其参与研究的意愿并获取家长的知情同意，将同意参与研究的超重肥胖儿童招募入组。每所学校约招募100名学生，5所学校共招募约500名学生。 纳入标准：①7~11 岁小学生；②超重肥胖，依据中国肥胖工作组 2018 年制定的《中国学龄儿童少年超重肥胖筛查 BMI 分类标准》判定；③在学校食堂吃午餐，在家吃早晚餐；④愿意参与研究并获得家长签署的书面知情同意书；④家长具备智能手机操作能力。

Inclusion criteria

1. School Inclusion Criteria and Sample Size Five eligible public elementary schools in Guangzhou that provide meals through school cafeterias were randomly selected and assigned to five groups: four intervention groups and one control group. Inclusion criteria: (1) Public elementary school; (2) Meals provided via school cafeteria; (3) Enrollment of at least 1,000 students to ensure sufficient overweight/obese children meeting inclusion criteria; (4) Willingness to cooperate with the research team in implementing meal intervention and collecting relevant data. 2. Student Inclusion Criteria and Sample Size Leveraging Guangzhou's annual physical fitness assessments for primary and secondary students, all enrolled students underwent measurements of physical indicators such as weight and height. Children meeting overweight/obesity criteria were preliminarily identified using the 2018 BMI Classification Standards for Screening Overweight and Obese School-Aged Children and Adolescents established by the Chinese Obesity Working Group. Further questionnaires were administered to preliminarily identified overweight/obese children to assess their school cafeteria meal patterns and presence of underlying conditions. Eligible children meeting criteria—those eating lunch at school cafeterias and consuming breakfast/dinner at home—were selected. Participation consent was obtained from both children and parents, with enrolled participants recruited into the study. Approximately 100 students were recruited from each school, totaling around 500 students across the five schools. Inclusion criteria: (1) Primary school students aged 7–11 years; (2)Overweight or obese, determined according to the "BMI Classification Standard for Screening Overweight and Obesity in Chinese School-Aged Children and Adolescents" established by the China Obesity Task Force in 2018; (3) Eat lunch in the school canteen and have breakfast and dinner at home; (4)Willing to participate in the study and have obtained written informed consent signed by parents; (5) Parents have the ability to operate a smartphone.

排除标准：

学校排除标准：符合以下任何一项的学校：①私立小学、国际学校等非公立教育机构；②学校不提供食堂供餐，或主要依赖第三方供餐公司配送等外部餐饮服务；③学校因管理、政策或其他原因无法配合研究干预措施的实施。 学生排除标准：符合以下任何一项的个体：①过去3个月内参加过其他减重项目；②过去3个月内使用过抗生素持续7天或以上；③患有药物、疾病等引起的继发性肥胖；④患有重要脏器严重疾病或存在进食障碍。

Exclusion criteria：

1.School Exclusion Criteria: Schools meeting any of the following criteria: (1) Non-public educational institutions such as private elementary schools or international schools;(2) Schools that do not provide cafeteria meals or primarily rely on external catering services like third-party meal delivery companies; (3) Schools unable to cooperate with the implementation of research interventions due to management, policy, or other reasons. 2.Student Exclusion Criteria: Individuals meeting any of the following: (1) Participation in other weight-loss programs within the past 3 months; (2) Use of antibiotics for 7 consecutive days or more within the past 3 months; (3) Secondary obesity caused by medication, disease, etc.; (4) Severe disease affecting major organs or presence of eating disorders.

研究实施时间：

Study execute time：

从 From 2025-04-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-10-29 00:00:00 至 To 2025-11-10 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

100

Group：

Control Group

Sample size：

干预措施：

常规健康宣教

干预措施代码：

Intervention：

Standard Health Education

Intervention code：

组别：

干预S组

样本量：

100

Group：

Intervention Group S

Sample size：

干预措施：

数字化配餐+AI动态调整食谱+营养报告推送

干预措施代码：

Intervention：

Digital Meal Planning + AI-Driven Dynamic Recipe Adjustment+nutrition report provided

Intervention code：

组别：

干预A组

样本量：

100

Group：

Intervention Group A

Sample size：

干预措施：

传统配餐+AI动态调整食谱+营养报告推送

干预措施代码：

Intervention：

Traditional meal planning+ AI-Driven Dynamic Recipe Adjustment+nutrition report provided

Intervention code：

组别：

干预B组

样本量：

100

Group：

Intervention Group B

Sample size：

干预措施：

传统配餐，无营养报告推送

干预措施代码：

Intervention：

Traditional meal planning, no nutrition report provided

Intervention code：

组别：

干预C组

样本量：

100

Group：

Intervention Group C

Sample size：

干预措施：

减重食谱推送

干预措施代码：

Intervention：

Weight Loss Recipe Recommendations

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guang Dong 

City：

Guangzhou 

单位(医院)：

建设六马路小学 

单位级别：

无 

Institution
hospital：

Jianshe Liuma Road Primary School

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guang Dong 

City：

Guangzhou 

单位(医院)：

新华街第二小学 

单位级别：

无 

Institution
hospital：

No. 2 Xinhua Street Primary School

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guang Dong 

City：

Guangzhou 

单位(医院)：

新华街第六小学 

单位级别：

无 

Institution
hospital：

No. 6 Xinhua Street Primary School

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州 

Country：

China 

Province：

Guang Dong 

City：

Guangzhou 

单位(医院)：

育才学校 

单位级别：

无 

Institution
hospital：

Yucai School

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China 

Province：

Guang Dong 

City：

Guangzhou 

单位(医院)：

南沙小学 

单位级别：

无 

Institution
hospital：

Nansha Primary School

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

体重

指标类型：

主要指标

Outcome：

Weight

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腰围

指标类型：

主要指标

Outcome：

Waist circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

身高

指标类型：

主要指标

Outcome：

Height

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉量

指标类型：

主要指标

Outcome：

Muscle

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

动态血糖

指标类型：

主要指标

Outcome：

Dynamic blood glucose

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

超敏C反应蛋白

指标类型：

主要指标

Outcome：

HsCRP

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血脂四项

指标类型：

主要指标

Outcome：

Four Blood Lipid Tests

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血尿酸

指标类型：

主要指标

Outcome：

Blood uric acid

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

空腹血糖

指标类型：

主要指标

Outcome：

Fasting blood glucose

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

空腹胰岛素

指标类型：

主要指标

Outcome：

Fasting insulin

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血压

指标类型：

主要指标

Outcome：

Blood pressure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

膳食评估

指标类型：

主要指标

Outcome：

Dietary Assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

睡眠状况

指标类型：

次要指标

Outcome：

Sleep Status

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

运动水平

指标类型：

次要指标

Outcome：

Level of athletic performance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

食欲评分

指标类型：

次要指标

Outcome：

Appetite Rating

Type：

Secondary indicator

测量时间点：

测量方法：

食欲评分问卷

Measure time point of outcome：

Measure method：

Appetite Rating Questionnaire

指标中文名：

臀围

指标类型：

主要指标

Outcome：

Hip circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肝肾功能

指标类型：

主要指标

Outcome：

Liver and kidney function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肠道菌群

指标类型：

主要指标

Outcome：

Gut microbiota

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

粪便

组织：

Sample Name：

Feces

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 7 岁 years
最大 Max age 11 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

研究采用整群随机对照干预试验，在广州市以学校食堂供餐的公立小学中，随机选取5所小学，每所学校招募约100名符合标准的7~11岁超重肥胖儿童作为研究对象。将5所小学随机分配到5组，其中4所为干预组，1所为对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The study employed a cluster randomized controlled intervention trial. Five public elementary schools in Guangzhou that provided cafeteria meals were randomly selected. Approximately 100 eligible overweight or obese children aged 7 to 11 years were recruited from each school as study participants. The five schools were randomly assigned to five groups: four intervention groups and one control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本试验为评估者盲、受试者及干预执行者非盲设计。

Blinding：

This trial employs an evaluator-blinded, subject- and intervention-provider-unblinded design.

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本研究通过自编问卷和现场体格测量、生物样本采集数据（包括人口学、暴露/行为问卷项、身高体重/腰围等体格测量值、血液与粪便）。问卷以纸质/电子表格形式采集（若为纸质，现场填写后由研究助理录入电子表格）；所有原始数据统一录入 Excel（按标准化变量名与编码）。录入人员经培训并按录入规范操作，关键变量实施双录或 10% 随机核查并由研究负责人复核。数据文件存放于单位受控服务器/加密云盘，启用访问权限与密码保护并定期备份，不对外共享数据。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

This study collected data through a self-designed questionnaire, on-site physical measurements, and biological sample collection (including demographic information, exposure/behavior questionnaire items, physical measurements such as height, weight, and waist circumference, as well as blood and stool samples). Questionnaires were collected in paper or electronic form (if on paper, they were filled out on-site and then entered into electronic spreadsheets by research assistants); all raw data were uniformly entered into Excel (following standardized variable names and coding). Data entry personnel were trained and followed entry protocols, with key variables subjected to double entry or 10% random checks and reviewed by the principal investigator. Data files were stored on the organization's controlled servers/encrypted cloud drives, with access permissions and password protection enabled, and were regularly backed up, without being shared externally.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-10-20 11:49:57
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