ChiCTR2500112339 版本V1.0 版本创建时间2025/11/12 16:50:48 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：

 ChiCTR2500112339 

最近更新日期：

Date of Last Refreshed on：

 2025-11-12 16:50:39 

注册时间：

Date of Registration：

 2025-11-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effects of intermittent dieting with ad-libitum intakes on body composition and psychological responses in obese females: a randomized controlled trial

Public title：

The effects of intermittent dieting with ad-libitum intakes on body composition and psychological responses in obese females: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effects of intermittent dieting with ad-libitum intakes on body composition and psychological responses in obese females: a randomized controlled trial

Scientific title：

The effects of intermittent dieting with ad-libitum intakes on body composition and psychological responses in obese females: 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：

Jaclyn Hei Tsang 

研究负责人：

Dr Sun Fenghua; Jaclyn Hei Tsang 

Applicant：

Jaclyn Hei Tsang 

Study leader：

Dr Sun Fenghua; Jaclyn Hei Tsang 

申请注册联系人电话：

Applicant telephone：

 +852 6337 6315

研究负责人电话：

Study leader's
telephone：

+852 2948 7854

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：

 jaclyn@s.eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

 fhsun@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：

No. 10 Lo Ping Road, Tai Po, New Territories

研究负责人通讯地址：

No. 10 Lo Ping Road, Tai Po, New Territories

Applicant address：

No. 10 Lo Ping Road, Tai Po, New Territories

Study leader's address：

No. 10 Lo Ping Road, Tai Po, New Territories

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 Health and Physical Education, the Education University of Hong Kong

Applicant's institution：

Department of Health and Physical Education, the Education University of Hong Kong

研究负责人所在单位：

Department of Health and Physical Education, the Education University of Hong Kong

Affiliation of the Leader：

Department of Health and Physical Education, 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：

 A2024-2025-0346-01

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

Name of the ethic committee：

Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-29 00:00:00

伦理委员会联系人：

Mr Desmond Kwok

Contact Name of the ethic committee：

Mr Desmond Kwok

伦理委员会联系地址：

No. 10 Lo Ping Road, Tai Po, New Territories

Contact Address of the ethic committee：

No. 10 Lo Ping Road, Tai Po, New Territories

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2948 8614

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hrec@eduhk.hk

研究实施负责（组长）单位：

The Education University of Hong Kong

Primary sponsor：

The Education University of Hong Kong

研究实施负责（组长）单位地址：

No. 10 Lo Ping Road, Tai Po, New Territories

Primary sponsor's address：

No. 10 Lo Ping Road, Tai Po, New Territories

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 Education University of Hong Kong

具体地址：

No. 10 Lo Ping Road, Tai Po, New Territories

Institution
hospital：

The Education University of Hong Kong

Address：

No. 10 Lo Ping Road, Tai Po, New Territories

经费或物资来源：

The Education University of Hong Kong

Source(s) of funding：

The Education University of Hong Kong

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.To investigate whether the incorporation of ad-libitum intakes during dieting serves as a viable weight reduction strategy as compared to the traditional strategy of continuous energy restriction, thereby giving new insight in combating with the global obesity phenomenon; 2.To back up the proposed physiological and psychological benefits of ad-libitum intakes commonly used among the fitness communities with empirical evidence.  

Objectives of Study：

1.To investigate whether the incorporation of ad-libitum intakes during dieting serves as a viable weight reduction strategy as compared to the traditional strategy of continuous energy restriction, thereby giving new insight in combating with the global obesity phenomenon; 2.To back up the proposed physiological and psychological benefits of ad-libitum intakes commonly used among the fitness communities with empirical evidence.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

untrained obese (BMI >=25) female Chinese adults (age 18-35)

Inclusion criteria

untrained obese (BMI >=25) female Chinese adults (age 18-35)

排除标准：

pregnancy, lactating women, history of eating disorders, psychological disorders, chronic diseases or other health problems that may affect participation; and are not involved in any dietary approaches for weight management in the past 12 months

Exclusion criteria：

pregnancy, lactating women, history of eating disorders, psychological disorders, chronic diseases or other health problems that may affect participation; and are not involved in any dietary approaches for weight management in the past 12 months

研究实施时间：

Study execute time：

从 From 2025-11-13 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-13 00:00:00 至 To 2025-11-30 00:00:00

干预措施：

Interventions：

组别：

Continuous Energy Restriction group

样本量：

 25

Group：

Continuous Energy Restriction group

Sample size：

干预措施：

8 weeks of diet intervention at 70% of energy balance

干预措施代码：

Intervention：

8 weeks of diet intervention at 70% of energy balance

Intervention code：

组别：

Ad-libitum intake group

样本量：

 25

Group：

Ad-libitum intake group

Sample size：

干预措施：

8 weeks of diet intervention at 70% energy balance with two ad-libitum feeding days per week

干预措施代码：

Intervention：

8 weeks of diet intervention at 70% energy balance with two ad-libitum feeding days per week

Intervention code：

组别：

Control group

样本量：

 25

Group：

Control group

Sample size：

干预措施：

Maintain habitual diet for 8 weeks

干预措施代码：

Intervention：

Maintain habitual diet for 8 weeks

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

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 The Education University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Education University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

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：

Cardiovascular Health Biomarkers

指标类型：

次要指标

Outcome：

Cardiovascular Health Biomarkers

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Resting Metabolic Rate

指标类型：

次要指标

Outcome：

Resting Metabolic Rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Eating behaviours

指标类型：

次要指标

Outcome：

Eating behaviours

Type：

Secondary 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 岁 years
最大 Max age 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

The random number sequence will be generated by an independent statistician using a random number generator software to ensure an unbiased allocation with a 1:1:1 ratio across the groups

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

The random number sequence will be generated by an independent statistician using a random number generator software to ensure an unbiased allocation with a 1:1:1 ratio across the groups

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：

None

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）：

None

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：

None

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

None

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：

  2025-11-12 16:50:39