ChiCTR2400092558 版本V1.0 版本创建时间2024/11/19 11:14:45 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：

 ChiCTR2400092558 

最近更新日期：

Date of Last Refreshed on：

 2024-11-19 11:14:27 

注册时间：

Date of Registration：

 2024-11-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effectiveness of the Personalized Healthy Eating Report Card on Improving Children’s Healthy Eating Behaviors: A Randomized Controlled Trial

Public title：

Effectiveness of the Personalized Healthy Eating Report Card on Improving Children’s Healthy Eating Behaviors: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of the Personalized Healthy Eating Report Card on Improving Children’s Healthy Eating Behaviors: A Randomized Controlled Trial

Scientific title：

Effectiveness of the Personalized Healthy Eating Report Card on Improving Children’s Healthy Eating Behaviors: A Randomized Controlled Trial

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：

Alison Wing Lam Wan 

研究负责人：

Derwin King Chung Chan 

Applicant：

Alison Wing Lam Wan 

Study leader：

Derwin King Chung Chan 

申请注册联系人电话：

Applicant telephone：

 +852 2948 7014

研究负责人电话：

Study leader's
telephone：

+852 2948 7071

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：

 alisonwan@s.eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

 derwin@eduhk.hk

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：

B1-2/F-35, EDUHK

研究负责人通讯地址：

B1-2/F-35, EDUHK

Applicant address：

No. 15, D2-2/F-30A, EDUHK

Study leader's address：

B1-2/F-35, EDUHK

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：

The Education University of Hong Kong

Applicant's institution：

The Education University of Hong Kong

研究负责人所在单位：

The Education University of Hong Kong

Affiliation of the Leader：

The Education University of Hong Kong

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：

 N/A

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：

Human Research Ethics Committee of The Education University of Hong Kong

Name of the ethic committee：

Human Research Ethics Committee of The Education University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-09-22 00:00:00

伦理委员会联系人：

Jacqueline Hui

Contact Name of the ethic committee：

Jacqueline Hui

伦理委员会联系地址：

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

Contact Address of the ethic committee：

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2948 8888

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：

Faculty of Education Human Development of The Education University of Hong Kong

Primary sponsor：

Faculty of Education Human Development of The Education University of Hong Kong

研究实施负责（组长）单位地址：

D1-G/F-02, The Education University of Hong Kong, 10 Lo Ping Road, Taipo, New Territories, Hong Kong

Primary sponsor's address：

D1-G/F-02, The Education University of Hong Kong, 10 Lo Ping Road, Taipo, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Faculty of Education Human Development of The Education University of Hong Kong

具体地址：

D1-G/F-02, The Education University of Hong Kong, 10 Lo Ping Road, Taipo, New Territories, Hong Kong

Institution
hospital：

NA Faculty of Education Human Development of The Education University of Hong Kong

Address：

D1-G/F-02, The Education University of Hong Kong, 10 Lo Ping Road, Taipo, New Territories, Hong Kong

经费或物资来源：

The project was funded by the Research Impact Cluster Fund by the Department of Early Childhood Education, the Education University of Hong Kong.

Source(s) of funding：

The project was funded by the Research Impact Cluster Fund by the Department of Early Childhood Education, the Education University of Hong Kong.

研究疾病：

Eating behaviours  

Target disease：

Eating behaviours

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：

随机平行对照 

Study design：

Parallel 

研究目的：

This study aims to examine the effectiveness of presenting the personalised Healthy Eating Report Card to parents to improve children’s eating behaviours and family home food environments (FHFEs). It evaluates the impact of the intervention on children’s overall grade of eating behaviours and FHFEs. The personalised Healthy Eating Report Card is tailored to each child and designed to promote healthy eating behaviours and FHFEs among pre-school children.  

Objectives of Study：

This study aims to examine the effectiveness of presenting the personalised Healthy Eating Report Card to parents to improve children’s eating behaviours and family home food environments (FHFEs). It evaluates the impact of the intervention on children’s overall grade of eating behaviours and FHFEs. The personalised Healthy Eating Report Card is tailored to each child and designed to promote healthy eating behaviours and FHFEs among pre-school children.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

We aim to recruit participants who should be Chinese parents or guardians, have at least one child aged 2-6 and be able to read Chinese to complete the questionnaires. In other words, we will recruit 300 parent and child dyads.

Inclusion criteria

We aim to recruit participants who should be Chinese parents or guardians, have at least one child aged 2-6 and be able to read Chinese to complete the questionnaires. In other words, we will recruit 300 parent and child dyads.

排除标准：

Their children with medical conditions are excluded from this study.

Exclusion criteria：

Their children with medical conditions are excluded from this study.

研究实施时间：

Study execute time：

从 From 2023-09-22 00:00:00至 To 2024-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-10-18 00:00:00 至 To 2024-04-15 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 100

Group：

Intervention group

Sample size：

干预措施：

Participants will receive the Healthy Eating Report Card.

干预措施代码：

Intervention：

Participants will receive the Healthy Eating Report Card.

Intervention code：

组别：

Usual Care Group

样本量：

 100

Group：

Usual Care Group

Sample size：

干预措施：

Participants will receive the advice leaflets established by the Hong Kong SAR government that are a current standard of healthy eating promotional materials for pre-school children.

干预措施代码：

Intervention：

Participants will receive the advice leaflets established by the Hong Kong SAR government that are a current standard of healthy eating promotional materials for pre-school children.

Intervention code：

组别：

Mere-Measurement Control Group

样本量：

 100

Group：

Mere-Measurement Control Group

Sample size：

干预措施：

Participants will not receive any intervention.

干预措施代码：

Intervention：

Participants will not receive any intervention.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The local kindergarten in Hong Kong 

单位级别：

 kindergarten 

Institution
hospital：

The local kindergarten in Hong Kong

Level of the institution：

kindergarten

测量指标：

Outcomes：

指标中文名：

Overall Report Card Score

指标类型：

主要指标

Outcome：

Overall Report Card Score

Type：

Primary indicator

测量时间点：

Pre and Post-test (1-month-after)

测量方法：

Validated parent self-report questionnaire

Measure time point of outcome：

Pre and Post-test (1-month-after)

Measure method：

Validated parent self-report questionnaire

指标中文名：

Score for Children’s Eating Behaviours

指标类型：

主要指标

Outcome：

Score for Children’s Eating Behaviours

Type：

Primary indicator

测量时间点：

Pre and Post-test (1-month-after)

测量方法：

Validated parent self-report questionnaire

Measure time point of outcome：

Pre and Post-test (1-month-after)

Measure method：

Validated parent self-report questionnaire

指标中文名：

Score for Family Home Food Environments

指标类型：

主要指标

Outcome：

Score for Family Home Food Environments

Type：

Primary indicator

测量时间点：

Pre and Post-test (1-month-after)

测量方法：

Validated parent self-report questionnaire

Measure time point of outcome：

Pre and Post-test (1-month-after)

Measure method：

Validated parent self-report questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

NA

Tissue：

NA

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

NA

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

For randomisation and treatment allocation, a simple randomisation method using a computer-generated random number will be employed to allocate the parent-child dyads in a 1:1:1 ratio to one of the following three groups. It is expected that this randomisation procedure will ensure that the differences in outcomes between the intervention group and control groups are comparable and theoretically attributed to the effects of intervention (Aggarwal & Ranganathan, 2019).

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

For randomisation and treatment allocation, a simple randomisation method using a computer-generated random number will be employed to allocate the parent-child dyads in a 1:1:1 ratio to one of the following three groups. It is expected that this randomisation procedure will ensure that the differences in outcomes between the intervention group and control groups are comparable and theoretically attributed to the effects of intervention (Aggarwal & Ranganathan, 2019).

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：

Under the single-blinded design, only the participants (not the research associate who delivered the assessments and intervention materials) were kept unaware of the study design, group allocation, and expected outcomes of the study, but they were informed of the study’s purposes.

Blinding：

Under the single-blinded design, only the participants (not the research associate who delivered the assessments and intervention materials) were kept unaware of the study design, group allocation, and expected outcomes of the study, but they were informed of the study’s purposes.

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

是Yes

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）：

Using OSF (Open Science Framework) to share the data Website: https://osf.io/dashboard

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

Using OSF (Open Science Framework) to share the data Website: https://osf.io/dashboard

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：

Data will be shared upon request. The study results are anticipated to be published in October 2025, and after three months, the data will be available for sharing.

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

Data will be shared upon request. The study results are anticipated to be published in October 2025, and after three months, the data will be available for sharing.

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：

  2024-11-19 11:14:27