今天是:2020-07-05 星期日

北京市海淀区初中生超重肥胖干预研究
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注册号:

Registration number:

ChiCTR2000033348 

最近更新日期:

Date of Last Refreshed on:

2020-05-29 

注册时间:

Date of Registration:

2020-05-29 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

北京市海淀区初中生超重肥胖干预研究 

Public title:

An intervention to prevent excessive weight gain in middle school students in Beijing, China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

北京市海淀区初中生超重肥胖干预研究 

Scientific title:

An intervention to prevent excessive weight gain in middle school students in Beijing, China 

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:

刘峥 

研究负责人:

沈艳辉 

Applicant:

Zheng Liu 

Study leader:

Yan-Hui Shen 

申请注册联系人电话:

Applicant telephone:

+86 010-82801222-109 

研究负责人电话:

Study leader's telephone:

+86 13811838512 

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:

liuzheng@bjmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

18310307841@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:

北京市海淀区学院路38号北京大学医学部 

研究负责人通讯地址:

北京市海淀区西北旺乡二街5号 

Applicant address:

Peking University Health Science Center, 38 Xueyuan Road, Haidian District, Beijing, China 

Study leader's address:

5 Second Xibeiwang Street, Haidian District, Beijing  

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:

北京大学公共卫生学院 

Applicant's institution:

School of Public Health, Peking University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019-018 

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:

北京市海淀区疾控中心学术委员会 

Name of the ethic committee:

The Academic Committee of Haidian CDC 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-22 

伦理委员会联系人:

沈艳辉 

Contact Name of the ethic committee:

Yan-Hui Shen 

伦理委员会联系地址:

北京市海淀区西北旺乡二街5号 

Contact Address of the ethic committee:

5 Second Xibeiwang Street, Haidian District, Beijing  

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

中关村科技园区海淀园管理委员会 

Primary sponsor:

Haidian Park Management Committee of Zhongguancun Science and Technology Park 

研究实施负责(组长)单位地址:

北京市海淀区西四环北路11号 

Primary sponsor's address:

11 West Fourth Ring Road North, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市海淀区疾控中心

具体地址:

海淀区西北旺乡二街5号

Institution
hospital:

Haidian District Centers for Diseases Prevention and Control

Address:

5 Second Xibeiwang Street, Haidian District

经费或物资来源:

海淀区支持核心区自主创新和产业发展专项资金 

Source(s) of funding:

The special funds for independent innovation and industrial development of Haidian District's core areas 

研究疾病:

儿童肥胖 

Target disease:

Childhood obesity 

研究疾病代码:

 

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 

研究目的:

评估智能手机辅助的干预是否可以有效提高学生和家长认知体重状态的准确性。 

Objectives of Study:

To evaluate the effectiveness of a smartphone-assisted intervention to improve students' and parental perception of students' weight status. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)学校校长对项目感兴趣并且同意遵守研究方案执行项目; (2)被选学校的肥胖率近似。 

Inclusion criteria

(1) the school principal interested in the programme and agreeing to comply with the protocol; (2) prevalence of obesity similar across schools that were selected. 

排除标准:

(1)过去一年曾实施过肥胖干预或其他类似项目; (2)寄宿学校、特殊学校或少数民族学校。 

Exclusion criteria:

(1) having implemented an obesity prevention intervention or similar intervention programme in the past one year; (2) boarding schools, specialty schools for children with talents or minority ethnic groups.  

研究实施时间:

Study execute time:

From2019-03-28To 2019-06-30 

干预措施:

Interventions:

组别:

干预组

样本量:

278

Group:

Intervention group

Sample size:

干预措施:

智能手机协助的干预

干预措施代码:

Intervention:

Smartphone-assisted intervention

Intervention code:

组别:

对照组

样本量:

278

Group:

Control group

Sample size:

干预措施:

学校照常课程

干预措施代码:

Intervention:

Usual practice

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

海淀CDC 

单位级别:

N/A 

Institution
hospital:

Haidian CDC  

Level of the institution:

N/A 

测量指标:

Outcomes:

指标中文名:

学生认知自我体重的准确性

指标类型:

主要指标 

Outcome:

Students' accurate perception of their own weight status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

家长认知学生体重的准确性

指标类型:

主要指标 

Outcome:

Parental accurate perception of their children's weight status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学生低估自我体重

指标类型:

次要指标 

Outcome:

Students' underestimation of their own weight 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:

学生高估自我体重

指标类型:

次要指标 

Outcome:

Students' overestimation of their own weight 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:

家长低估学生体重

指标类型:

次要指标 

Outcome:

Parental underestimation of their children's weight 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:

家长高估学生体重

指标类型:

次要指标 

Outcome:

Parental overestimation of their children's weight 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:

体重管理行为变化阶段的比例

指标类型:

次要指标 

Outcome:

Percentage of stage of change for weight management

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数

指标类型:

次要指标 

Outcome:

Body mass index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重指数标准化评分

指标类型:

次要指标 

Outcome:

Body mass index Z-score

Type:

Secondary 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:

没有需要收集的样本

组织:

Sample Name:

no sample collected

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

这是一个非随机研究。

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

This is a non-randomized trial.

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

IPD将从ResMan平台分享,http://www.medresman.org.cn。

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

IPD will be shared via ResMan, http://www.medresman.org.cn.

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:

通过ResMan平台管理数据

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

Data will be managed via ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-29
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