ChiCTR2500101322 版本V1.0 版本创建时间2025/04/23 15:27:24 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：

 ChiCTR2500101322 

最近更新日期：

Date of Last Refreshed on：

 2025-04-23 15:26:56 

注册时间：

Date of Registration：

 2025-04-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Promoting physical activity among primary school children and their families in Hong Kong: A community-based healthy lifestyle program ("F.I.T. Family")

Public title：

Promoting physical activity among primary school children and their families in Hong Kong: A community-based healthy lifestyle program ("F.I.T. Family")

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Promoting physical activity among primary school children and their families in Hong Kong: A community-based healthy lifestyle program ("F.I.T. Family")

Scientific title：

Promoting physical activity among primary school children and their families in Hong Kong: A community-based healthy lifestyle program ("F.I.T. Family")

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：

Dai Zihan 

研究负责人：

Stephen H.S. Wong 

Applicant：

Dai Zihan 

Study leader：

Stephen H.S. Wong 

申请注册联系人电话：

Applicant telephone：

 +852 3943 6757

研究负责人电话：

Study leader's
telephone：

+852 3943 6757

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：

 daizh@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 hsswong@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：

G02, Kwok Sports Building, CUHK

研究负责人通讯地址：

G08, Kwok Sports Building, CUHK

Applicant address：

G02, Kwok Sports Building, CUHK

Study leader's address：

G08, Kwok Sports Building, CUHK

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：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Applicant's institution：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Sports Science and Physical Education, 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：

 2022.358

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 Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-11-11 00:00:00

伦理委员会联系人：

Envy Lee, Joint CUHK-NTEC CREC

Contact Name of the ethic committee：

Envy Lee, Joint CUHK-NTEC CREC

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 2632 3935

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：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Primary sponsor：

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

G02, Kwok Sports Building, CUHK

Primary sponsor's address：

G02, Kwok Sports Building, CUHK

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 SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR, China

Institution
hospital：

The Chinese University of Hong Kong

Address：

The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR, China

经费或物资来源：

University Grants Committee Research Impact Fund

Source(s) of funding：

University Grants Committee Research Impact Fund

研究疾病：

None  

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：

随机平行对照 

Study design：

Parallel 

研究目的：

To examine the efficacy of a 4-month home-based lifestyle program ("F.I.T. Family") for primary school children and their families in local Hong Kong communities targeting 2018 Hong Kong Report Card indicators with poor grades (Physical Fitness, Family, and Obesity).  

Objectives of Study：

To examine the efficacy of a 4-month home-based lifestyle program ("F.I.T. Family") for primary school children and their families in local Hong Kong communities targeting 2018 Hong Kong Report Card indicators with poor grades (Physical Fitness, Family, and Obesity).

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. Parents (father or/and mother) with their primary school-aged children (6–12 years old); 2. local Chinese families being able to read and speak Cantonese.

Inclusion criteria

1. Parents (father or/and mother) with their primary school-aged children (6–12 years old); 2. local Chinese families being able to read and speak Cantonese.

排除标准：

1. chronic medical and health conditions, including but not limited to cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases; 2. severe high blood pressure (>= 180/100 mm Hg); 3. a history of myocardial infarction, uncompensated heart failure, or unstable angina pectoris; 4. any pre-existing medical or physical issues that could affect the experimental test and training, as suggested by the current exercise prescription guidelines.

Exclusion criteria：

1. chronic medical and health conditions, including but not limited to cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases; 2. severe high blood pressure (>= 180/100 mm Hg); 3. a history of myocardial infarction, uncompensated heart failure, or unstable angina pectoris; 4. any pre-existing medical or physical issues that could affect the experimental test and training, as suggested by the current exercise prescription guidelines.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-01-02 00:00:00 至 To 2024-06-30 00:00:00

干预措施：

Interventions：

组别：

Intervention group (F.I.T Family)

样本量：

 200

Group：

Intervention group (F.I.T Family)

Sample size：

干预措施：

Families assigned to the F.I.T. group will participate in 15 consecutive weekly sessions, consisting of both counseling and practical components, specifically designed to influence the lifestyle behaviors of family members. Each session will last 60 minutes.

干预措施代码：

Intervention：

Families assigned to the F.I.T. group will participate in 15 consecutive weekly sessions, consisting of both counseling and practical components, specifically designed to influence the lifestyle behaviors of family members. Each session will last 60 minutes.

Intervention code：

组别：

Waitlist control group

样本量：

 200

Group：

Waitlist control group

Sample size：

干预措施：

Families assigned to the control group will receive no intervention and will continue with their daily lives as normal. However, family units that are allocated to Control group will be offered identical counselling and practical sessions after post intervention evaluation.

干预措施代码：

Intervention：

Families assigned to the control group will receive no intervention and will continue with their daily lives as normal. However, family units that are allocated to Control group will be offered identical counselling and practical sessions after post intervention evaluation.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Cardiorespiratory Fitness

指标类型：

主要指标

Outcome：

Cardiorespiratory Fitness

Type：

Primary indicator

测量时间点：

Two time points, before and after the intervention period

测量方法：

PACER Test

Measure time point of outcome：

Two time points, before and after the intervention period

Measure method：

PACER Test

指标中文名：

Anthropometry and body composition

指标类型：

主要指标

Outcome：

Anthropometry and body composition

Type：

Primary indicator

测量时间点：

Two time points, before and after the intervention period

测量方法：

Bioelectrical impedance analyzer

Measure time point of outcome：

Two time points, before and after the intervention period

Measure method：

Bioelectrical impedance analyzer

指标中文名：

Waist circumference

指标类型：

主要指标

Outcome：

Waist circumference

Type：

Primary indicator

测量时间点：

Two time points, before and after the intervention period

测量方法：

Anthropometric tape

Measure time point of outcome：

Two time points, before and after the intervention period

Measure method：

Anthropometric tape

指标中文名：

Sedentary sitting time

指标类型：

主要指标

Outcome：

Sedentary sitting time

Type：

Primary indicator

测量时间点：

Two time points, before and after the intervention period

测量方法：

Accelerometer device

Measure time point of outcome：

Two time points, before and after the intervention period

Measure method：

Accelerometer device

指标中文名：

Psychosocial related outcomes

指标类型：

次要指标

Outcome：

Psychosocial related outcomes

Type：

Secondary indicator

测量时间点：

Two time points, before and after the intervention period

测量方法：

Questionnaires including PA attitude, family PA time, enjoyment responses and quality of life.

Measure time point of outcome：

Two time points, before and after the intervention period

Measure method：

Questionnaires including PA attitude, family PA time, enjoyment responses and quality of life.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

NA

组织：

Sample Name：

NA

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 6 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）：

Following baseline measurements, block randomization will be applied to allocate family units to either "F.I.T. Family" intervention (FIT) or waitlist control (CON) in a 1:1 ratio. Randomization allocation software will be used to generate random block sizes. A sequentially numbered procedure will be applied.

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

Following baseline measurements, block randomization will be applied to allocate family units to either "F.I.T. Family" intervention (FIT) or waitlist control (CON) in a 1:1 ratio. Randomization allocation software will be used to generate random block sizes. A sequentially numbered procedure will be applied.

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：

Randomization and allocation will be operated by a trained research staff who is independent of the study and supervised by the Project Coordinator.

Blinding：

Randomization and allocation will be operated by a trained research staff who is independent of the study and supervised by the Project Coordinator.

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）：

Clearly explain the purpose for requesting and obtaining the data, and contact the principal investigator via email (hsswong@cuhk.edu.hk) to get the data.

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

Clearly explain the purpose for requesting and obtaining the data, and contact the principal investigator via email (hsswong@cuhk.edu.hk) to get the data.

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：

NA

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

NA

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：

  2025-04-23 15:26:56