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Plyometric-based High Intensity Interval Training (Plyo-HIIT): A Pragmatic Randomized Controlled Trial to Prevent Childhood-onset Obesity by Improving Muscle-to-Fat Ratio in a Primary School Setting
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注册号：

Registration number：

 ChiCTR2500110770 

最近更新日期：

Date of Last Refreshed on：

 2025-10-20 17:21:23 

注册时间：

Date of Registration：

 2025-10-20 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Plyometric-based High Intensity Interval Training (Plyo-HIIT): A Pragmatic Randomized Controlled Trial to Prevent Childhood-onset Obesity by Improving Muscle-to-Fat Ratio in a Primary School Setting

Public title：

Plyometric-based High Intensity Interval Training (Plyo-HIIT): A Pragmatic Randomized Controlled Trial to Prevent Childhood-onset Obesity by Improving Muscle-to-Fat Ratio in a Primary School Setting

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Plyometric-based High Intensity Interval Training (Plyo-HIIT): A Pragmatic Randomized Controlled Trial to Prevent Childhood-onset Obesity by Improving Muscle-to-Fat Ratio in a Primary School Setting

Scientific title：

Plyometric-based High Intensity Interval Training (Plyo-HIIT): A Pragmatic Randomized Controlled Trial to Prevent Childhood-onset Obesity by Improving Muscle-to-Fat Ratio in a Primary School Setting

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：

刘颖 

研究负责人：

谭子敬 

Applicant：

Ying Liu  

Study leader：

Bjorn Tsz-King Tam  

申请注册联系人电话：

Applicant telephone：

 +852 9044 8298

研究负责人电话：

Study leader's
telephone：

+852 3411 7004

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：

 24481335@life.hkbu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 bjorntam@hkbu.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：

香港马鞍山雅涛居2栋3D

研究负责人通讯地址：

香港浸会大学AAB楼,9楼,930室

Applicant address：

Flat D, 3/F, Tower 2, The waterside, Ma On Shan, New Territories, Hongkong

Study leader's address：

AAB 930, 15 Baptist University Road, Hong Kong Baptist University

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：

香港浸会大学,体育与健康科学系

Applicant's institution：

Hong Kong Baptist University, Department of Sports and Health Sciences

研究负责人所在单位：

香港浸会大学,体育与健康科学系

Affiliation of the Leader：

Hong Kong Baptist University, Department of Sports and Health Sciences

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：

 REC/22-23/0536

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：

香港浸会大学研究伦理委员会

Name of the ethic committee：

Research Ethics Committee of Hong Kong Baptist University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-08-14 00:00:00

伦理委员会联系人：

Ray TANG

Contact Name of the ethic committee：

Ray TANG

伦理委员会联系地址：

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

Contact Address of the ethic committee：

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3411 2623

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 raytang@hkbu.edu.hk

研究实施负责（组长）单位：

香港浸会大学

Primary sponsor：

Hong Kong Baptist University (Department of Sport, Physical Education and Health)

研究实施负责（组长）单位地址：

香港浸会大学学术与行政大楼 AAB930 室，九龙塘，香港

Primary sponsor's address：

Academic and Administration Building, Room AAB930, HKBU, Kowloon Tong, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong kong

City：

单位(医院)：

香港浸会大学

具体地址：

香港浸会大学学术与行政大楼 AAB930 室，九龙塘，香港

Institution
hospital：

Hong Kong Baptist University

Address：

Academic and Administration Building, Room AAB930, HKBU, Kowloon Tong, Hong Kong

经费或物资来源：

MRI测量核准金额 HK$126,000

Source(s) of funding：

HKBU Faculty Niche Research Area HK$126,000

研究疾病：

儿童期肥胖的预防  

Target disease：

Childhood-onset obesity prevention

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：

评估以增强式训练为核心的高强度间歇训练（Plyo-HIIT）在小学环境中改善儿童肌肉/脂肪比从而预防儿童期肥胖的有效性；假设：与健康教育对照相比，结构化体适能课程与 Plyo-HIIT 均可提高肌肉/脂肪比，且 Plyo-HIIT 在干预后6个月仍能保持更佳的肌肉/脂肪比。  

Objectives of Study：

Objective: To evaluate whether a school-based, plyometric-focused high-intensity interval training (Plyo-HIIT) program improves the muscle-to-fat ratio in primary school children as a strategy to prevent childhood-onset obesity. Hypotheses: (1) Compared with a health-education control, both the structured fitness program and Plyo-HIIT will increase the muscle-to-fat ratio at post-intervention; (2) Plyo-HIIT will show greater improvements and will maintain superiority at the 6-month follow-up.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

存在任何可能妨碍其参加 Plyo-HIIT 干预的身心疾病者，包括但不限于： 1. 限制或禁忌体力活动的肌肉骨骼系统疾病； 2. 慢性疾病（如慢性哮喘、肾脏疾病、糖尿病），或正在/近期使用可能影响体成分或胰岛素分泌的药物； 3. 有心脏病史或体检发现心脏病相关证据； 4. 高血压； 5. 已诊断的注意缺陷多动障碍（ADHD）； 6. 经临床判断不宜参加者，或在常规学校体育课中出现过症状（如呼吸困难、胸痛、心悸等）。

Exclusion criteria：

Children with any medical conditions, both physical and mental, that hamper their participation in the Plyo-HIIT intervention, including but not limited to – • Children with musculoskeletal diseases that limit or contraindicate physical activity • Children with chronic diseases (chronic asthma, kidney disease, diabetes), or who have received medications that alter body composition or insulin secretion. • Children who on medical exam have shown any history or evidence of heart disease • Hypertension • Diagnosed attention deficit hypersensitivity disorder • Children who at the clinical discretion cannot participate or who have presented any symptoms (dyspnea, chest pain, palpitations, among others) during the regular school physical education class.

研究实施时间：

Study execute time：

从 From 2023-10-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-26 00:00:00 至 To 2025-03-14 00:00:00

干预措施：

Interventions：

组别：

样本量：

 70

Group：

Health Education (HE)

Sample size：

干预措施：

干预措施代码：

 HE

Intervention：

Two 45-min classroom sessions per week for 16 weeks; content covers physical activity, diet, and mental health; delivered by trained instructors; attendance recorded.

Intervention code：

组别：

样本量：

 70

Group：

Structured Fitness Program (SFP)

Sample size：

干预措施：

干预措施代码：

 SFP

Intervention：

Two 45-min sessions per week for 16 weeks; 10-min warm-up → ~30-min moderate-to-vigorous activities using games/sport drills (e.g., basketball, football, dance, short sprints, obstacle course); target 60–80% age-predicted HRmax with HR monitoring → cool-down.

Intervention code：

组别：

样本量：

 70

Group：

Plyo-HIIT

Sample size：

干预措施：

干预措施代码：

 Plyo-HIIT

Intervention：

Two 45-min sessions per week for 16 weeks; 10-min warm-up → 4×2-min rope skipping with 1-min active recovery → progressive plyometric blocks: wks 1–4 (double-leg jumps/burpees), wks 5–8 (hurdle/zig-zag jumps), wks 9–12 (split-squat & tuck jumps), wks 13–16 (single-leg cone & zig-zag jumps; inchworm + plank jacks); each drill 15 s work + 15 s rest for 2 min; 1-min rest between blocks → cool-down; attendance and safety monitored.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

Hong Kong

单位(医院)：

 香港浸会大学 

单位级别：

 大学 

Institution
hospital：

Hong Kong Baptist University

Level of the institution：

University

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 香港各参与小学 

单位级别：

 无 

Institution
hospital：

Participating Primary Schools in Hong Kong

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Muscle-to-fat ratio (MRI; mid-thigh & abdomen L4–L5)

指标类型：

主要指标

Outcome：

Muscle-to-fat ratio (MRI; mid-thigh & abdomen L4–L5)

Type：

Primary indicator

测量时间点：

Baseline (Week 0); Post-intervention (Week 16); 6-month follow-up (≈Week 40)

测量方法：

3T MRI three-point Dixon; segment skeletal muscle and fat compartments; compute MFR = muscle volume / fat volume.

Measure time point of outcome：

Baseline (Week 0); Post-intervention (Week 16); 6-month follow-up (≈Week 40)

Measure method：

3T MRI three-point Dixon; segment skeletal muscle and fat compartments; compute MFR = muscle volume / fat volume.

指标中文名：

Body fat percentage

指标类型：

次要指标

Outcome：

Body fat percentage

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

Multi-frequency BIA (e.g., InBody 770) in standardized posture.

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

Multi-frequency BIA (e.g., InBody 770) in standardized posture.

指标中文名：

Lower-limb power (vertical & squat jump)

指标类型：

次要指标

Outcome：

Lower-limb power (vertical & squat jump)

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

Multi-frequency BIA (e.g., InBody 770) in standardized posture.

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

Multi-frequency BIA (e.g., InBody 770) in standardized posture.

指标中文名：

Handgrip strength

指标类型：

次要指标

Outcome：

Handgrip strength

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

Digital handgrip dynamometer; dominant hand; best of three.

指标中文名：

Cardiorespiratory fitness (20-m shuttle run)

指标类型：

次要指标

Outcome：

Cardiorespiratory fitness (20-m shuttle run)

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

Léger 20-m shuttle test; VO?max estimated via standard equation.

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

Léger 20-m shuttle test; VO?max estimated via standard equation.

指标中文名：

Flexibility (sit-and-reach)

指标类型：

次要指标

Outcome：

Flexibility (sit-and-reach)

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

Sit-and-reach box; best of two/three trials.

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

Sit-and-reach box; best of two/three trials.

指标中文名：

BMI

指标类型：

次要指标

Outcome：

BMI

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

Height (stadiometer) & weight (scale); BMI = kg/m2.

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

Height (stadiometer) & weight (scale); BMI = kg/m2.

指标中文名：

Physical activity level (PAQ-C)

指标类型：

次要指标

Outcome：

Physical activity level (PAQ-C)

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

Physical Activity Questionnaire for Older Children (PAQ-C).

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

Physical Activity Questionnaire for Older Children (PAQ-C).

指标中文名：

Hair cortisol concentration

指标类型：

次要指标

Outcome：

Hair cortisol concentration

Type：

Secondary indicator

测量时间点：

Baseline; Post-intervention; 6-month follow-up

测量方法：

3-cm proximal hair segment; cortisol assay (immunoassay; LC-MS/MS for QC subsample).

Measure time point of outcome：

Baseline; Post-intervention; 6-month follow-up

Measure method：

3-cm proximal hair segment; cortisol assay (immunoassay; LC-MS/MS for QC subsample).

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Hair

组织：

Hair (3-cm proximal segment from the scalp)

Sample Name：

Hair

Tissue：

Hair (3-cm proximal segment from the scalp)

人体标本去向

 使用后销毁  

说明

Assay hair cortisol; analyze within study period and destroy after analysis (no long-term storage).

Fate of sample：

Destruction after use  

Note：

Assay hair cortisol; analyze within study period and destroy after analysis (no long-term storage).

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 9 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）：

An independent researcher will generate a 1:1:1 random sequence using Random Allocation Software 2.0 (variable block sizes). Allocation will be concealed by a centrally held list; assignments are revealed after baseline assessments. The PI does not interact with participants. Outcome assessors are blinded, and participants are instructed not to disclose their group during testing.

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

An independent researcher will generate a 1:1:1 random sequence using Random Allocation Software 2.0 (variable block sizes). Allocation will be concealed by a centrally held list; assignments are revealed after baseline assessments. The PI does not interact with participants. Outcome assessors are blinded, and participants are instructed not to disclose their group during testing.

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：

Because of the nature of the interventions, participants and instructors are not blinded. Outcome assessors and data analysts/statisticians are blinded; case-report forms and the database use group codes (A/B/C) rather than group names. The PI and field team remain masked during data collection. Participants are instructed not to disclose their allocation during assessments.

Blinding：

Because of the nature of the interventions, participants and instructors are not blinded. Outcome assessors and data analysts/statisticians are blinded; case-report forms and the database use group codes (A/B/C) rather than group names. The PI and field team remain masked during data collection. Participants are instructed not to disclose their allocation during assessments.

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）：

We will share de-identified individual participant data (IPD), the data dictionary/metadata, statistical code, and the final protocol on an open repository (Open Science Framework, OSF). Access will be public with a DOI after the primary results are published. If journal policy requires controlled access, requests will be considered by the PI upon a signed data-use agreement. Planned timing: within 12 months after publication; retention: at least 5 years.

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

We will share de-identified individual participant data (IPD), the data dictionary/metadata, statistical code, and the final protocol on an open repository (Open Science Framework, OSF). Access will be public with a DOI after the primary results are published. If journal policy requires controlled access, requests will be considered by the PI upon a signed data-use agreement. Planned timing: within 12 months after publication; retention: at least 5 years.

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 will be collected using standard paper CRFs and entered into a secure electronic database (REDCap or equivalent) hosted by HKBU. Features include role-based access control, audit trails, range and logic checks, automatic date/time stamps, and weekly encrypted backups. Each participant is assigned a unique study ID; identifying information is stored separately from research data. Double data entry (or 10% verification) will be used for primary outcomes. A Data Management Plan defines version control, query resolution, and procedures for data locking and archiving.

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

Data will be collected using standard paper CRFs and entered into a secure electronic database (REDCap or equivalent) hosted by HKBU. Features include role-based access control, audit trails, range and logic checks, automatic date/time stamps, and weekly encrypted backups. Each participant is assigned a unique study ID; identifying information is stored separately from research data. Double data entry (or 10% verification) will be used for primary outcomes. A Data Management Plan defines version control, query resolution, and procedures for data locking and archiving.

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：

  2025-10-20 17:21:16
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