ChiCTR2500105143 版本V1.0 版本创建时间2025/06/30 11:28:02 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：

 ChiCTR2500105143 

最近更新日期：

Date of Last Refreshed on：

 2025-06-30 11:27:36 

注册时间：

Date of Registration：

 2025-06-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Intervention for Emotional Eating in Youth

Public title：

Intervention for Emotional Eating in Youth

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Emotional Eating in Youth: The Development of a Brief Self-compassion Intervention for Emotional Eating

Scientific title：

Emotional Eating in Youth: The Development of a Brief Self-compassion Intervention for Emotional Eating

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：

Cheung Suet Ying 

研究负责人：

Cheung Suet Ying 

Applicant：

Cheung Suet Ying 

Study leader：

Cheung Suet Ying 

申请注册联系人电话：

Applicant telephone：

 +853 6345 3567

研究负责人电话：

Study leader's
telephone：

+853 6345 3567

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：

 sallycheung.cu@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 sallycheung.cu@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 sallycheung.cu@gmail.com

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 sallycheung.cu@gmail.com

申请注册联系人通讯地址：

研究负责人通讯地址：

Applicant address：

Room 627, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong.

Study leader's address：

Room 627, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, 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：

Applicant's institution：

University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

 0201250526

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：

Departmental Research Ethics Committee, Department of Psychology, The University of Hong Kong

Name of the ethic committee：

Departmental Research Ethics Committee, Department of Psychology, The University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-02 00:00:00

伦理委员会联系人：

Robin Lee

Contact Name of the ethic committee：

Robin Lee

伦理委员会联系地址：

Room 627, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong

Contact Address of the ethic committee：

Room 627, 6/F, The Jockey Club Tower, Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3917 7122

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：

The University of Hong Kong

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong.

Primary sponsor's address：

Centennial Campus, The University of Hong Kong, Pokfulam Road, 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)：

Department of Psychology at The University of Hong Kong

具体地址：

Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong.

Institution
hospital：

Department of Psychology at The University of Hong Kong

Address：

Centennial Campus, The University of Hong Kong, Pokfulam Road, Hong Kong.

经费或物资来源：

Source(s) of funding：

n/a

研究疾病：

Emotional Eating  

Target disease：

Emotional Eating

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 study aims to develop and evaluate the efficacy of a brief self-compassion interventions targeting adolescents with elevated emotional eating problems. The self-compassion intervention will be adapted from Kelly & Carter (2015)’s three-week self-help self-compassion intervention for binge eating. The present study will first investigate the efficacy of the enhanced self-compassion intervention by comparing the treatment outcome on emotional eating of the intervention group with the control group. Apart from the primary outcome, the mechanisms of change through possible mediating roles of shame, experiential avoidance and self-compassion will also be evaluated in the study. Furthermore, to explore the additional value of the attachment prime technique, the treatment effect of the self-compassion intervention with the enhanced content on secure attachment priming will be compared with a basic self-compassion intervention without such components.  

Objectives of Study：

The study aims to develop and evaluate the efficacy of a brief self-compassion interventions targeting adolescents with elevated emotional eating problems. The self-compassion intervention will be adapted from Kelly & Carter (2015)’s three-week self-help self-compassion intervention for binge eating. The present study will first investigate the efficacy of the enhanced self-compassion intervention by comparing the treatment outcome on emotional eating of the intervention group with the control group. Apart from the primary outcome, the mechanisms of change through possible mediating roles of shame, experiential avoidance and self-compassion will also be evaluated in the study. Furthermore, to explore the additional value of the attachment prime technique, the treatment effect of the self-compassion intervention with the enhanced content on secure attachment priming will be compared with a basic self-compassion intervention without such components.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Participants will be youth from the age of 12 to 39 recruited from secondary schools, university, and the general community in Hong Kong on a voluntary basis. The inclusion criteria will be having emotional eating, indicated by a score > 3.25 on the emotional eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ-E), and regular access to the internet for accessing study materials. The cut-off score of 3.25 is recommended to be used in research to identify individuals with negative emotional eating (Frayn & Kn?uper, 2018; van Strien et al., 2012) and has been used for categorizing emotional eaters in a Hong Kong prevalence study with undergraduate sample (Sze et al., 2021). Participants must be fluent in Cantonese and able to read and write in traditional Chinese.

Inclusion criteria

Participants will be youth from the age of 12 to 39 recruited from secondary schools, university, and the general community in Hong Kong on a voluntary basis. The inclusion criteria will be having emotional eating, indicated by a score > 3.25 on the emotional eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ-E), and regular access to the internet for accessing study materials. The cut-off score of 3.25 is recommended to be used in research to identify individuals with negative emotional eating (Frayn & Kn?uper, 2018; van Strien et al., 2012) and has been used for categorizing emotional eaters in a Hong Kong prevalence study with undergraduate sample (Sze et al., 2021). Participants must be fluent in Cantonese and able to read and write in traditional Chinese.

排除标准：

Participants will be excluded from the study if they are: 1) having medical condition that known to affect eating; 2) having substance abuse; 3) having active psychotic, manic, dissociative or PTSD symptoms; 4) concurrent psychotherapy treatment or adjusting to changing psychiatric medication.

Exclusion criteria：

Participants will be excluded from the study if they are: 1) having medical condition that known to affect eating; 2) having substance abuse; 3) having active psychotic, manic, dissociative or PTSD symptoms; 4) concurrent psychotherapy treatment or adjusting to changing psychiatric medication.

研究实施时间：

Study execute time：

从 From 2025-03-24 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-30 00:00:00 至 To 2026-11-15 00:00:00

干预措施：

Interventions：

组别：

Intervention group 1

样本量：

 73

Group：

Intervention group 1

Sample size：

干预措施：

self-compassion intervention

干预措施代码：

Intervention：

self-compassion intervention

Intervention code：

组别：

Control group

样本量：

 73

Group：

Control group

Sample size：

干预措施：

non-active control condition

干预措施代码：

Intervention：

non-active control condition

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)：

 University of Hong Kong 

单位级别：

 University 

Institution
hospital：

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 Methodist Lee Wai Lee College 

单位级别：

 Secondary School 

Institution
hospital：

The Methodist Lee Wai Lee College

Level of the institution：

Secondary School

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Scientia Secondary School 

单位级别：

 Secondary School 

Institution
hospital：

Scientia Secondary School

Level of the institution：

Secondary School

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Kiangsu-Chekiang College (Kwai Chung) 

单位级别：

 Secondary School 

Institution
hospital：

Kiangsu-Chekiang College (Kwai Chung)

Level of the institution：

Secondary School

测量指标：

Outcomes：

指标中文名：

The emotional eating subscale of the Chinese version of the Dutch Eating Behavior Questionnaire

指标类型：

主要指标

Outcome：

The emotional eating subscale of the Chinese version of the Dutch Eating Behavior Questionnaire

Type：

Primary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Self-compassion Scale – Youth version

指标类型：

主要指标

Outcome：

Self-compassion Scale – Youth version

Type：

Primary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

State Self-Compassion Scale

指标类型：

次要指标

Outcome：

State Self-Compassion Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Chinese version of the Experience of Shame Scale

指标类型：

次要指标

Outcome：

Chinese version of the Experience of Shame Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Brief Experiential Avoidance Questionnaire (BEAQ; Gamez et al., 2014)

指标类型：

次要指标

Outcome：

Brief Experiential Avoidance Questionnaire (BEAQ; Gamez et al., 2014)

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

The state shame subscale of the Self-Emotion Scale developed by Chen & Wu (2008)

指标类型：

次要指标

Outcome：

The state shame subscale of the Self-Emotion Scale developed by Chen & Wu (2008)

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Subjective Units of Distress scale (SUDs)

指标类型：

附加指标

Outcome：

Subjective Units of Distress scale (SUDs)

Type：

Additional indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

The negative affect subscale of the Chinese version of the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; Liu et al., 2020; Thompson, 2017)

指标类型：

附加指标

Outcome：

The negative affect subscale of the Chinese version of the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF; Liu et al., 2020; Thompson, 2017)

Type：

Additional indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Urge to Eat

指标类型：

次要指标

Outcome：

Urge to Eat

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Short version of State Adult Attachment Measure (SAAM-S; Gillath et al., 2009; McGuire et al., 2018 )

指标类型：

次要指标

Outcome：

Short version of State Adult Attachment Measure (SAAM-S; Gillath et al., 2009; McGuire et al., 2018 )

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

The Fear of Self-Compassion Subscale of the Fears of Compassion Scale (FCS-SC)

指标类型：

次要指标

Outcome：

The Fear of Self-Compassion Subscale of the Fears of Compassion Scale (FCS-SC)

Type：

Secondary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

Emotional eating frequency by the total number of days and episodes over past week

指标类型：

主要指标

Outcome：

Emotional eating frequency by the total number of days and episodes over past week

Type：

Primary indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

指标中文名：

SCOFF questionnaire

指标类型：

附加指标

Outcome：

SCOFF questionnaire

Type：

Additional indicator

测量时间点：

测量方法：

Questionnaire

Measure time point of outcome：

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

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 10 岁 years
最大 Max age 39 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）：

Premuted block randomization, participants will be blinded to their treatment allocation. One of the researchers will generate the randomization number sequence using the online tool of Sealed Envelope Ltd. The other researcher will be responsible to allocate the participants according to the randomization sequence. Sealed Envelope Ltd. 2024. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 15 Jun 2025]

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

Premuted block randomization, participants will be blinded to their treatment allocation. One of the researchers will generate the randomization number sequence using the online tool of Sealed Envelope Ltd. The other researcher will be responsible to allocate the participants according to the randomization sequence. Sealed Envelope Ltd. 2024. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 15 Jun 2025]

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：

premuted block randomization, participants will be blinded to their treatment allocation.

Blinding：

premuted block randomization, participants will be blinded to their treatment allocation.

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）：

n/a

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

n/a

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 using Qualtrics system, and paper and pen questionnaire, followed by data entry into Qualtrics system. Data management: All information collected in this research project will be kept confidential and used for research purposes only. To ensure confidentiality, we will use an assigned code to identify a participant. No school, individual or personal information will be identified in any of the publications and public dissemination activities. All of the obtained information will be securely stored in a locked cabinet at the researchers’ office.

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

Data collection using Qualtrics system, and paper and pen questionnaire, followed by data entry into Qualtrics system. Data management: All information collected in this research project will be kept confidential and used for research purposes only. To ensure confidentiality, we will use an assigned code to identify a participant. No school, individual or personal information will be identified in any of the publications and public dissemination activities. All of the obtained information will be securely stored in a locked cabinet at the researchers’ office.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-06-30 11:27:36