ChiCTR2500105843 版本V1.0 版本创建时间2025/07/11 16:44:00 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：

 ChiCTR2500105843 

最近更新日期：

Date of Last Refreshed on：

 2025-07-11 16:43:55 

注册时间：

Date of Registration：

 2025-07-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于身体素养的青少年肥胖干预（PLOT试验）：一项随机对照试验

Public title：

A Physical Literacy-based intervention for Obese Teenagers (PLOT Trial): A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于身体素养的青少年肥胖干预（PLOT试验）：一项随机对照试验

Scientific title：

A Physical Literacy-based intervention for Obese Teenagers (PLOT Trial): 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：

Chan Ying Crystal 

研究负责人：

Chan Ying Crystal 

Applicant：

Chan Ying Crystal 

Study leader：

Chan Ying Crystal 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8413

研究负责人电话：

Study leader's
telephone：

+852 2252 8413

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：

 ychan@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 ychan@cuhk.edu.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：

Rm 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

研究负责人通讯地址：

Rm 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

Applicant address：

Rm 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

Study leader's address：

Rm 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

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：

Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Applicant's institution：

Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

研究负责人所在单位：

Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Affiliation of the Leader：

Jockey Club School of Public Health and Primary Care, The Chinese 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：

 2023.669

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：

Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committees

Name of the ethic committee：

Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committees

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-01-16 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2144 5926

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：

CUHK Direct Grant

Primary sponsor：

CUHK Direct Grant

研究实施负责（组长）单位地址：

Rm 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

Primary sponsor's address：

Rm 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., 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)：

Jockey Club School of Public Health and Primary Care

具体地址：

Room 417, Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Shatin

Institution
hospital：

The Chinese University of Hong Kong

Address：

Hong Kong

经费或物资来源：

Academic Institutions (CUHK), Corporate Sponsorship (Swire Resources, Marathon Sports)

Source(s) of funding：

Academic Institutions (CUHK), Corporate Sponsorship (Swire Resources, Marathon Sports)

研究疾病：

Obesity  

Target disease：

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

The concept of physical literacy (PL) has gained significant attention in health promotion in recent years, encompassing elements such as motivation, physical competence, knowledge, and engagement in physical activities. Including PL in weight reduction and management programme is getting popular among older adults with weight problems, but evidence involving children and young adults are scarce. To fill this void, we propose a parallel-group, randomised controlled trial of a physical literacy-based intervention for weight management of obese Chinese young adults between 12 and 18 years-old. Eligible Chinese teenagers and their parents will be recruited through partnering non-government organisations. Upon consent collection, participants will be randomised into intervention (physical literacy-based intervention) or control group (usual care), and follow-up in a ten-weeks duration. Primary outcome is body mass index and body fat percentage using bioimpedance analysis; secondary outcomes are physical activity levels measured by The International Physical Activity Questionnaires and physical literacy measured by Physical Literacy Instrument for adolescents.  

Objectives of Study：

The concept of physical literacy (PL) has gained significant attention in health promotion in recent years, encompassing elements such as motivation, physical competence, knowledge, and engagement in physical activities. Including PL in weight reduction and management programme is getting popular among older adults with weight problems, but evidence involving children and young adults are scarce. To fill this void, we propose a parallel-group, randomised controlled trial of a physical literacy-based intervention for weight management of obese Chinese young adults between 12 and 18 years-old. Eligible Chinese teenagers and their parents will be recruited through partnering non-government organisations. Upon consent collection, participants will be randomised into intervention (physical literacy-based intervention) or control group (usual care), and follow-up in a ten-weeks duration. Primary outcome is body mass index and body fat percentage using bioimpedance analysis; secondary outcomes are physical activity levels measured by The International Physical Activity Questionnaires and physical literacy measured by Physical Literacy Instrument for adolescents.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Obese Chinese young adults between 12 and 18 years-old

Inclusion criteria

Obese Chinese young adults between 12 and 18 years-old

排除标准：

Unable to give consent

Exclusion criteria：

Unable to give consent

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2025-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-16 00:00:00 至 To 2024-12-20 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 40

Group：

1

Sample size：

干预措施：

Physical literacy-based intervention for weight management

干预措施代码：

 I

Intervention：

Physical literacy-based intervention for weight management

Intervention code：

组别：

2

样本量：

 40

Group：

2

Sample size：

干预措施：

Control group using usual care

干预措施代码：

 C

Intervention：

Control group using usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

HKSAR

City：

单位(医院)：

 香港中文大學 

单位级别：

 三级 

Institution
hospital：

The Chinese Unviersity of Hong Kong

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

身高體重比

指标类型：

主要指标

Outcome：

Body Mass Index

Type：

Primary indicator

测量时间点：

基線和活動完成後

测量方法：

Measure time point of outcome：

Baseline and completion of intervention

Measure method：

指标中文名：

體脂比

指标类型：

次要指标

Outcome：

Body Fat percentage

Type：

Secondary indicator

测量时间点：

基線和活動完成後

测量方法：

阻抗分析仪

Measure time point of outcome：

Baseline and completion of intervention

Measure method：

electroimpedance analyser

指标中文名：

有關健康行為的知識，態度和行為

指标类型：

附加指标

Outcome：

Health related knowledge, attitude and behavior　

Type：

Additional indicator

测量时间点：

基線和活動完成後

测量方法：

問卷

Measure time point of outcome：

Baseline and completion of intervention

Measure method：

Survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 8 岁 years
最大 Max age 12 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）：

以學校為單為的整群随机对照试验

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

Cluster randomization using participating school as unit

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：

无

Blinding：

No 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

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）：

国家生物信息中心 (https://ngdc.cncb.ac.cn/gsub/)

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

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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：

参与者将通过使用 Qualtrics 平台的在线问卷招募。问卷将通过各种在线平台和渠道分发，包括通过 WhatsApp 发送包含链接的短信。采用便利抽样方法，专门针对符合参与条件的个人进行招募。数据的收集与管理由项目团队成员和 CREC 共同保障。

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

Participants will be recruited through an online questionnaire using the Qualtrics platform. The questionnaire will be distributed through various online platforms and channels, including the distribution of a text message via WhatsApp containing a link. The convenience sampling method was employed to specifically target individuals who meet the criteria for participation. Data collection and management are safeguarded by project team members and CREC.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-11 16:43:55