ChiCTR2600115926 版本V1.0 版本创建时间2026/01/04 09:30:55 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：

 ChiCTR2600115926 

最近更新日期：

Date of Last Refreshed on：

 2026-01-04 09:30:49 

注册时间：

Date of Registration：

 2026-01-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

An innovative approach to combine intermittent dieting (INTD) with high-intensity interval exercise (HIIE) for curbing central obesity: A comparative randomized controlled trial

Public title：

An innovative approach to combine intermittent dieting (INTD) with high-intensity interval exercise (HIIE) for curbing central obesity: A comparative randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

An innovative approach to combine intermittent dieting (INTD) with high-intensity interval exercise (HIIE) for curbing central obesity: A comparative randomized controlled trial

Scientific title：

An innovative approach to combine intermittent dieting (INTD) with high-intensity interval exercise (HIIE) for curbing central obesity: A comparative 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：

ZHANG Borui 

研究负责人：

Eric Tsz Chun POON 

Applicant：

ZHANG Borui 

Study leader：

Eric Tsz Chun POON 

申请注册联系人电话：

Applicant telephone：

 +852 5601 4410

研究负责人电话：

Study leader's
telephone：

+852 3943 7157

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：

 boruizhang@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 eric.poon@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：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

研究负责人通讯地址：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Applicant address：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Study leader's address：

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

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

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：

 2024.529-T

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：

 2024-11-07 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 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Primary sponsor's address：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, 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)：

The Chinese University of Hong Kong

具体地址：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

Kowk Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

经费或物资来源：

Health and Medical Research Fund

Source(s) of funding：

Health and Medical Research Fund

研究疾病：

Central Obesity  

Target disease：

Central 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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The proposed study aims to investigate the effects of high-intensity interval exercise (HIIE) and an intermittent diet (INTD) separately and their combined effects in physically inactive adults with central obesity.  

Objectives of Study：

The proposed study aims to investigate the effects of high-intensity interval exercise (HIIE) and an intermittent diet (INTD) separately and their combined effects in physically inactive adults with central 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：

The target population of the proposed study will be physically inactive middle-aged adults (aged 40–64 years) with central obesity in Hong Kong. This particular age group is chosen as the prevalence of central obesity generally increased with age according to the Population Health Survey 2020-22 (2). Physical inactivity will be defined as having less than 3 days of 30-minute moderate-intensity physical activity per week and will be objectively assessed using a device-based measure (i.e. activPAL accelerometer) (3). Central obesity is defined as having a waist circumference 90 centimeters (cm) or above for men and 80 cm or above for women (2). Furthermore, a waist-to-hip ratio at 0.90 or above for men and 0.85 for women also signify centrally obese.

Inclusion criteria

The target population of the proposed study will be physically inactive middle-aged adults (aged 40–64 years) with central obesity in Hong Kong. This particular age group is chosen as the prevalence of central obesity generally increased with age according to the Population Health Survey 2020-22 (2). Physical inactivity will be defined as having less than 3 days of 30-minute moderate-intensity physical activity per week and will be objectively assessed using a device-based measure (i.e. activPAL accelerometer) (3). Central obesity is defined as having a waist circumference 90 centimeters (cm) or above for men and 80 cm or above for women (2). Furthermore, a waist-to-hip ratio at 0.90 or above for men and 0.85 for women also signify centrally obese.

排除标准：

Participants who are not centrally obese will be excluded.

Exclusion criteria：

Participants who are not centrally obese will be excluded.

研究实施时间：

Study execute time：

从 From 2026-01-05 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-05 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 25

Group：

Group 1

Sample size：

干预措施：

Perform HIIE (10× 1-minute brisk walk/run @80%HRmax, with 1-minute active recovery @50%HRmax), 3 times/week (on non-consecutive days), and maintain a usual diet

干预措施代码：

Intervention：

Perform HIIE (10× 1-minute brisk walk/run @80%HRmax, with 1-minute active recovery @50%HRmax), 3 times/week (on non-consecutive days), and maintain a usual diet

Intervention code：

组别：

Group 2

样本量：

 25

Group：

Group 2

Sample size：

干预措施：

Follow INTD prescribed by a registered dietitian (reduce caloric intake by 35% for 5 days, and consume the maintenance calories for 2 consecutive days)

干预措施代码：

Intervention：

Follow INTD prescribed by a registered dietitian (reduce caloric intake by 35% for 5 days, and consume the maintenance calories for 2 consecutive days)

Intervention code：

组别：

Group 3

样本量：

 25

Group：

Group 3

Sample size：

干预措施：

Combining HIIE and INTD

干预措施代码：

Intervention：

Combining HIIE and INTD

Intervention code：

组别：

Group 4

样本量：

 25

Group：

Group 4

Sample size：

干预措施：

Control (only receive standardized educational leaflets)

干预措施代码：

Intervention：

Control (only receive standardized educational leaflets)

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 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：

Waist circumference

指标类型：

主要指标

Outcome：

Waist circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Body Composition

指标类型：

主要指标

Outcome：

Body Composition

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cardiorespiratory Fitness (VO2max)

指标类型：

次要指标

Outcome：

Cardiorespiratory Fitness (VO2max)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Lipid Profiles

指标类型：

次要指标

Outcome：

Lipid Profiles

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Glycated Haemoglobin (HbA1C) Level

指标类型：

次要指标

Outcome：

Glycated Haemoglobin (HbA1C) Level

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Blood Pressure

指标类型：

次要指标

Outcome：

Blood Pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Physical Activity level

指标类型：

附加指标

Outcome：

Physical Activity level

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Dietary Intake

指标类型：

附加指标

Outcome：

Dietary Intake

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Adherence

指标类型：

附加指标

Outcome：

Adherence

Type：

Additional 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：

Blood

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 40 岁 years
最大 Max age 64 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）：

Participants will be randomised by an independent research assistant using a computer-based random number generator.

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

Participants will be randomised by an independent research assistant using a computer-based random number generator.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Participants were not informed of the specific hypothesis of the study, but due to the nature of the intervention, participants and instructors cannot be blinded. The assessors will be blinded to the group allocation during the evaluation of the indicators before, during, and after the intervention.

Blinding：

Participants were not informed of the specific hypothesis of the study, but due to the nature of the intervention, participants and instructors cannot be blinded. The assessors will be blinded to the group allocation during the evaluation of the indicators before, during, and after the intervention.

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）：

NA

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

NA

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 collection forms will be designed by the study protocol, collected using a standardized and compliant procedure, and recorded on dedicated data collection forms. Paper-based data will be securely stored in locked cabinets, and electronic data will be entered into an encrypted database by the researchers, with access restricted to the principal researchers only. All data will be double-checked after recording to ensure accuracy and consistency. Participants' information was coded to ensure privacy. All data will be managed and protected in accordance with ethical requirements for three years after completion of the study. After the retention period, all electronic and paper documents will be destroyed to ensure data security.

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

Data collection forms will be designed by the study protocol, collected using a standardized and compliant procedure, and recorded on dedicated data collection forms. Paper-based data will be securely stored in locked cabinets, and electronic data will be entered into an encrypted database by the researchers, with access restricted to the principal researchers only. All data will be double-checked after recording to ensure accuracy and consistency. Participants' information was coded to ensure privacy. All data will be managed and protected in accordance with ethical requirements for three years after completion of the study. After the retention period, all electronic and paper documents will be destroyed to ensure data security.

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：

  2026-01-04 09:30:49