学生营养健康评估专项队列项目

注册号:

Registration number:

ChiCTR2500097327 

最近更新日期:

Date of Last Refreshed on:

2025-02-17 17:02:18 

注册时间:

Date of Registration:

2025-02-17 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

学生营养健康评估专项队列项目

Public title:

Shenzhen Student Health and Nutrition Assessment cohort

注册题目简写:

English Acronym:

研究课题的正式科学名称:

学生营养健康评估专项队列项目

Scientific title:

Shenzhen Student Health and Nutrition Assessment cohort

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:

李妍 

研究负责人:

熊静帆 

Applicant:

Yan Li 

Study leader:

Jingfan Xiong 

申请注册联系人电话:

Applicant telephone:

+86 159 7295 6518

研究负责人电话:

Study leader's
telephone:

+86 135 1086 6799

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:

412799649@qq.com

研究负责人电子邮件:

Study leader's E-mail:

sanming_mijie@163.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

深圳市罗湖区布心路2021号

研究负责人通讯地址:

深圳市罗湖区布心路2021号

Applicant address:

No.2021 Buxin Road, Luohu District, Shenzhen, 518001, China

Study leader's address:

No.2021 Buxin Road, Luohu District, Shenzhen, 518001, China

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

深圳市慢性病防治中心

Applicant's institution:

Shenzhen Center for Chronic Disease Control

研究负责人所在单位:

深圳市慢性病防治中心

Affiliation of the Leader:

Shenzhen Center for Chronic Disease Control

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

SZCCC-2024-003-01-PJ

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:

深圳市慢性病防治中心伦理委员会

Name of the ethic committee:

Ethics Committee of Shenzhen Center for Chronic Disease Control

伦理委员会批准日期:

Date of approved by ethic committee:

2025-01-23 00:00:00

伦理委员会联系人:

李霜君

Contact Name of the ethic committee:

Shuangjun Li

伦理委员会联系地址:

深圳罗湖布心路2021号

Contact Address of the ethic committee:

No.2021 Buxin Road, Luohu District, Shenzhen, 518001, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 755 2510 5229

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:

深圳市慢性病防治中心

Primary sponsor:

Shenzhen Center for Chronic Disease Control

研究实施负责(组长)单位地址:

深圳市罗湖区布心路2021号

Primary sponsor's address:

No.2021 Buxin Road, Luohu District, Shenzhen, 518001, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

深圳

市(区县):

Country:

China

Province:

ShenZhen

City:

单位(医院):

深圳市慢性病防治中心

具体地址:

深圳市罗湖区布心路2021号

Institution
hospital:

Shenzhen Center for Chronic Disease Control

Address:

No.2021 Buxin Road, Luohu District, Shenzhen, 518001, China

经费或物资来源:

深圳市“医疗卫生三名工程”项目(SZSM 202311020)

Source(s) of funding:

Sanming Project of Medicine in Shenzhen (SZSM 202311020)

研究疾病:

学生常见病  

Target disease:

Common illnesses among students

研究疾病代码:

Target disease code:

研究类型:

流行病学研究

Study type:

Epidemilogical research

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

1.在深圳市营养与健康学校通过动态随访建立学生个体健康档案,掌握学生常见病(肥胖及相关代谢性疾病、近视、龋齿、脊柱侧弯、心理健康等)的流行特征和变化趋势; 2.基于身体脂肪及其分布研究儿童精准肥胖评价指标体系,解析不同身体成分组分对儿童肥胖相关健康风险的差异化效应; 3.探索学龄儿童常见病的行为、环境和遗传因素,梳理多病的共同危险因素(多病共因),构建儿童常见病精准预测预警模型,为制定儿童常见病多病共防策略和措施提供科学依据; 4.评估相关卫生政策及项目的实施效果。  

Objectives of Study:

1. Establish individual health records of students in Shenzhen Nutrition and Health School through dynamic follow-up to grasp the epidemic characteristics and changing trends of students' common diseases (obesity and related metabolic diseases, myopia, dental caries, scoliosis, mental health, etc.); 2. Based on body fat and its distribution, the precision obesity evaluation index system for children was studied, and the differentiated effects of different body components on obesity-related health risks in children were analyzed; 3. Explore the behavioral, environmental and genetic factors of common diseases in school-age children, sort out the common risk factors (common causes of multiple diseases), build an accurate prediction and early warning model of common diseases in children, and provide scientific basis for the formulation of common prevention strategies and measures of children's common diseases; 4. Evaluate the effectiveness of relevant health policies and programs.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

患有严重疾病或残疾不能参加调查; 缺勤、病假或休学致不能参加调查。

Exclusion criteria:

Have a serious illness or disability that prevents them from participating in the survey. Absenteeism, sick leave or suspension from school precluded participation in the survey.

研究实施时间:

Study execute time:

From 2025-03-01 00:00:00 To 2027-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-03-01 00:00:00 To 2025-04-01 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

4000

Group:

Observation group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

深圳 

市(区县):

 

Country:

China

Province:

ShenZhen

City:

单位(医院):

深圳市慢性病防治中心 

单位级别:

无 

Institution
hospital:

Shenzhen Center for Chronic Disease Control

Level of the institution:

N/A

测量指标:

Outcomes:

指标中文名:

身体成分

指标类型:

主要指标

Outcome:

Body Composition

Type:

Primary indicator

测量时间点:

2025-3-3与2027-3

测量方法:

生物电阻抗

Measure time point of outcome:

2025-3-3 and 2027-3

Measure method:

Bioelectrical Impedance Analysis

指标中文名:

体重指数

指标类型:

主要指标

Outcome:

body mass index

Type:

Primary indicator

测量时间点:

2025-3-3与2027-3

测量方法:

Measure time point of outcome:

2025-3-3 and 2027-3

Measure method:

指标中文名:

骨密度

指标类型:

次要指标

Outcome:

Bone mineral density

Type:

Secondary 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:

次要指标

Outcome:

Blood pressure

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝脏超声

指标类型:

次要指标

Outcome:

Liver ultrasound

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

青春期发育

指标类型:

次要指标

Outcome:

Tanner

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

握力

指标类型:

次要指标

Outcome:

Grip

Type:

Secondary 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:

次要指标

Outcome:

waist circumference

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率

指标类型:

次要指标

Outcome:

heart rate

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心血管结构功能

指标类型:

次要指标

Outcome:

cardiac function and structure

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人口社会学特征

指标类型:

次要指标

Outcome:

Demographic characteristics

Type:

Secondary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

生活行为因素

指标类型:

次要指标

Outcome:

behavioural factors

Type:

Secondary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

体力活动水平

指标类型:

次要指标

Outcome:

physical activity

Type:

Secondary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

心里健康

指标类型:

次要指标

Outcome:

mental health

Type:

Secondary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

营养素养

指标类型:

次要指标

Outcome:

Nutritional literacy

Type:

Secondary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

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:

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 6 years
最大 Max age 13 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):

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否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):

NA

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

NA

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:

纸质问卷采集,SPSS和R进行数据管理分析。

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

Paper questionnaire collecte data, data management and analysis using SPSS and R.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2025-02-17 17:02:08