ChiCTR2500109186 版本V1.0 版本创建时间2025/09/15 09:34:49 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2500109186 

最近更新日期:

Date of Last Refreshed on:

2025-09-15 09:34:41 

注册时间:

Date of Registration:

2025-09-15 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于社交媒体的培训课程对改善婴幼儿养育人喂养知识和行为的效果研究

Public title:

Effectiveness of social media-based training courses in improving feeding knowledge and behaviour among infant caregivers

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于社交媒体的培训课程对改善婴幼儿养育人喂养知识和行为的效果研究

Scientific title:

Effectiveness of social media-based training courses in improving feeding knowledge and behaviour among infant caregivers

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:

吴琼 

研究负责人:

张延峰 

Applicant:

Wu Qiong 

Study leader:

Zhang Yanfeng 

申请注册联系人电话:

Applicant telephone:

+86 150 0135 2418

研究负责人电话:

Study leader's
telephone:

+86 136 8101 7812

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:

wuqiong063@126.com

研究负责人电子邮件:

Study leader's E-mail:

summyzh@126.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:

北京市朝阳区雅宝路2号

研究负责人通讯地址:

北京市朝阳区雅宝路2号

Applicant address:

No. 2 Yabao Road, Chaoyang District, Beijing

Study leader's address:

No. 2 Yabao Road, Chaoyang 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:

首都儿科研究所

Applicant's institution:

Capital Institute of Pediatrics

研究负责人所在单位:

首都儿科研究所

Affiliation of the Leader:

Capital Institute of Pediatrics

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:

SHERLL2025072

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:

首都儿科研究所伦理委员会

Name of the ethic committee:

Ethics Committee of Capital Institute of Pediatrics

伦理委员会批准日期:

Date of approved by ethic committee:

2025-07-21 00:00:00

伦理委员会联系人:

王秋月

Contact Name of the ethic committee:

Wang Qiuyue

伦理委员会联系地址:

北京市朝阳区雅宝路2号

Contact Address of the ethic committee:

No. 2 Yabao Road, Chaoyang District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 8562 8195

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:

首都儿科研究所

Primary sponsor:

Capital Institute of Pediatrics

研究实施负责(组长)单位地址:

北京市朝阳区雅宝路2号

Primary sponsor's address:

No. 2 Yabao Road, Chaoyang 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):

首都儿科研究所

具体地址:

朝阳区雅宝路2号

Institution
hospital:

Capital Institute of Pediatrics

Address:

No. 2 Yabao Road, Chaoyang District, Beijing

经费或物资来源:

首儿药业(北京)有限公司

Source(s) of funding:

Shou'er Pharmaceutical (Beijing) Co., LTD

研究疾病:

无  

Target disease:

None

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

研究设计:

单臂 

Study design:

Single arm 

研究目的:

通过社交媒体开展婴幼儿喂养培训,并评估其改善养育人喂养知识和行为的效果。  

Objectives of Study:

Infant feeding training was conducted through social media and its effectiveness in improving caregivers' feeding knowledge and behavior was assessed.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1. 拥有6-35月龄婴幼儿的养育人 2.主要养育人能用普通话阅读,并能通过手机使用微信,且具备上网条件 3. 知情同意并能积极配合

Inclusion criteria

1. Parent of a child aged 6-35 months 2. The primary parent can read Mandarin, use wechat through mobile phone, and have Internet access 3. Informed consent and active cooperation

排除标准:

1. 儿童有结构性或遗传的出生缺陷,如神经管畸形、先天性心脏病、苯丙酮尿症等 2.主要养育人拒绝参加

Exclusion criteria:

1. Children have structural or genetic birth defects, such as neural tube defects, congenital heart disease, phenylketonuria, etc 2. The primary caregiver refused to participate

研究实施时间:

Study execute time:

From 2025-07-01 00:00:00 To 2026-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-09-15 00:00:00 To 2026-06-30 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

900

Group:

Experimental group

Sample size:

干预措施:

在公众号中开展婴幼儿喂养培训课程,针对不同月龄儿童的营养需求和发育特点,进行婴幼儿喂养知识和技能的健康教育。

干预措施代码:

Intervention:

Conduct infant and toddler feeding training courses in the public account, focusing on the nutritional needs and developmental characteristics of children at different ages, to provide health education on knowledge and skills for infant and toddler feeding.

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):

首都儿科研究所 

单位级别:

无 

Institution
hospital:

Capital Institute of Pediatrics

Level of the institution:

None

测量指标:

Outcomes:

指标中文名:

最低膳食频次

指标类型:

主要指标

Outcome:

Minimum meal frequency

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最低可接受膳食

指标类型:

主要指标

Outcome:

Minimum acceptable diet

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最低膳食多样性

指标类型:

主要指标

Outcome:

Minimum dietary diversity

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

养育人对辅食喂养核心知识的知晓率

指标类型:

主要指标

Outcome:

Knowledge rate of caregivers about core knowledge of complementary feeding

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

回应性喂养

指标类型:

主要指标

Outcome:

Responsive feeding

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:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 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):

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:

None

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):

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:

病例记录表

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

Case Record Form, CRF

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:

 2025-09-15 09:34:41