ChiCTR2400092057 版本V1.0 版本创建时间2024/11/08 09:51:23 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：

ChiCTR2400092057 

最近更新日期：

Date of Last Refreshed on：

2024-11-08 09:50:56 

注册时间：

Date of Registration：

2024-11-08 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于移动健康技术的运动干预对改善肥胖男生体重和健康水平的研究

Public title：

A study of an exercise intervention based on mobile health technology to improve weight and health in obese male students

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于移动健康技术的运动干预对改善肥胖男生体重和健康水平的研究

Scientific title：

A study of an exercise intervention based on mobile health technology to improve weight and health in obese male students

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：

张秦珑 

研究负责人：

周志雄 

Applicant：

Zhang Qinlong 

Study leader：

Zhou Zhixiong 

申请注册联系人电话：

Applicant telephone：

+86 132 9018 5041

研究负责人电话：

Study leader's telephone：

+86 10 8209 9709

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：

1044645043@qq.com

研究负责人电子邮件：

Study leader's E-mail：

zhou126@126.com

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：

北京市海淀区北太平庄街道北三环西路11号首都体育学院

研究负责人通讯地址：

北京市海淀区北太平庄街道北三环西路11号首都体育学院

Applicant address：

Capital Institute of Physical Education, No. 11, North Third Ring West Road, North Taipingzhuang Street, Haidian District, Beijing

Study leader's address：

Consent to the experiment

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：

首都体育学院

Applicant's institution：

Capital University of Physical Education And Sports

研究负责人所在单位：

首都体育学院

Affiliation of the Leader：

Capital University of Physical Education And Sports

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024A063

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：

首都体育学院学术委员会伦理道德专门委员会

Name of the ethic committee：

Ethics Committee of the Academic Committee of Capital Institute of Physical Education

伦理委员会批准日期：

Date of approved by ethic committee：

2024-04-11 00:00:00

伦理委员会联系人：

付全

Contact Name of the ethic committee：

Fu Quan

伦理委员会联系地址：

北京市海淀区北太平庄街道北三环西路11号首都体育学院

Contact Address of the ethic committee：

Capital Institute of Physical Education, No. 11, North Third Ring West Road, North Taipingzhuang Street, Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8209 9035

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：

首都体育学院

Primary sponsor：

Capital University of Physical Education And Sports

研究实施负责（组长）单位地址：

北京市海淀区北太平庄街道北三环西路11号首都体育学院

Primary sponsor's address：

Capital Institute of Physical Education, No. 11, North Third Ring West Road, North Taipingzhuang Street, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都体育学院

具体地址：

北京市海淀区北太平庄街道北三环西路11号首都体育学院

Institution
hospital：

Capital University of Physical Education And Sports

Address：

Capital Institute of Physical Education, No. 11, North Third Ring West Road, North Taipingzhuang Street, Haidian District, Beijing

经费或物资来源：

国家重点研发计划

Source(s) of funding：

National Key R&D Program(NKRDP)

Target disease：

Exercise and obesity in male college students with physical fitness

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：

基于移动健康技术的运动干预广泛开展，但利用移动健康APP和运动手表进行干预改善超重与肥胖男大学生的体质健康的有效性和可行性还未知，本研究比较了移动健康技术开展的线上干预和体能教练指导的线下干预对超重与肥胖男大学生体质健康的影响。  

Objectives of Study：

Exercise interventions based on mobile health technology are widely available, but the effectiveness and feasibility of interventions using mobile health apps and exercise watches to improve the physical health of overweight and obese male college students are unknown, and this study compares the effects of online interventions carried out by mobile health technology and offline interventions guided by physical trainers on the physical health of overweight and obese male college students.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

本研究的纳入标准是:(1)年龄在20-30岁(2)24≤BMI＜28；BMI≥28(3)在校男大学生/研究生

Inclusion criteria

The inclusion criteria for this study were:(1) age 20-30 years (2) 24 ≤ BMI < 28; BMI ≥ 28;(3)Male undergraduates/postgraduates

排除标准：

排除标准如下:(1)运动禁忌症(2)有心血管、糖尿病等慢性疾病(3)乙肝、结核等传染病(4)长期抽烟。

Exclusion criteria：

the exclusion criteria were as follows:(1) contraindications to exercise (2) chronic diseases such as cardiovascular and diabetes mellitus (3) infectious diseases such as Hepatitis B and Tuberculosis (4) chronic smoking.

研究实施时间：

Study execute time：

从 From 2024-04-12 00:00:00至 To 2024-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-12 00:00:00 至 To 2024-04-19 00:00:00  

干预措施：

Interventions：

组别：

线上组

样本量：

22

Group：

Online group

Sample size：

干预措施：

线上组在基线测试过程中，研究人员传授运动手表使用方法，以及安全教育。完成基线测试后，通过腾讯会议进行线上训练的组织与监督。每周每人进行三次运动干预，针对训练情况自主选择个性化训练方案，训练过程中佩戴运动手表并通过首体健身APP对照示范动作视频自主训练。每次训练结束以图片或视频方式在微信群中完成训练打卡。线上组受试者根据自己的训练情况，在参与训练前一天选择需要练习的训练组别，根据训练内容分为三个组别A、B、C（力量训练+有氧训练）训练内容组成，A、B、C三个组别相对应的三个时间段所有受试者练习内容一致便于研究人员进行监督。每周三次训练内容的顺序可以自由选择。

干预措施代码：

Intervention：

The online group was taught how to use the sports watch by the researcher during the baseline test, as well as safety education. After completing the baseline test, online training was organised and supervised through Tencent Conference. Each person conducted three exercise interventions per week, independently selected personalised training programmes for the training situation, wore the exercise watch during training and trained independently against the demonstration videos through the First Body Fitness APP. At the end of each training session, a training punch card was posted in the WeChat group in the form of a picture or video. Online group of subjects according to their own training, the day before participating in the training to choose the training group need to practice, according to the training content is divided into three groups A, B, C (strength training + aerobic training) training content composition, A, B, C three groups corresponding to the three time periods of all subjects to practice the content of the same to facilitate the supervision of the researchers. The order of the three training sessions per week could be chosen freely.

Intervention code：

组别：

线下组

样本量：

23

Group：

Offline group

Sample size：

干预措施：

线下组由专业体能教练指导，每周每人进行三次运动干预。线下组的力量训练使用哑铃进行，外加卷腹练习；有氧训练采用跑步的形式进行，每次30min,共计1组。练习前后进行热身与放松各10分钟。每周三次训练按照规定计划执行，不可调换调整。

干预措施代码：

Intervention：

The offline group was guided by a professional fitness coach, and each person underwent three exercise interventions per week. The offline group used dumbbells for strength training, plus curling exercises; aerobic training was in the form of running, each time 30min, a total of 1 set. Warm-up and relaxation were performed for 10 min before and after the exercises. The three weekly training sessions were carried out according to the prescribed programme and could not be switched.

Intervention code：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

保持日常生活

干预措施代码：

Intervention：

Maintaining daily life

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

首都体育学院 

单位级别：

大学 

Institution
hospital：

Capital University of Physical Education And Sports

Level of the institution：

university

测量指标：

Outcomes：

指标中文名：

身体成分

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：

有氧耐力

指标类型：

次要指标

Outcome：

aerobic endurance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉力量

指标类型：

次要指标

Outcome：

muscle power

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：

血液

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 30 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用简单的随机化方法，利用SPSS软件随机抽样生成随机数。执行随机分组前规定1为线上组、2为线下组、3为对照组，依据研究对象被纳入的时间顺序对其进行编号（1-65），由统计员（非招募者）使用SPSS软件产生随机数字序列，对纳入的每一名研究对象产生一个对应的随机数字，按照随机数字由小到大的顺序排序，序号1-22分配到第1组，序号23-45分配到第2组，序号46-65分配到第3组。

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

The study used simple randomisation method to generate random numbers by random sampling using SPSS software. Before performing the randomisation grouping 1 was specified as the online group, 2 as the offline group and 3 as the control group, the study subjects were numbered based on the chronological order of their inclusion (1-65), the statistician (non-recruiter) used SPSS software to generate a sequence of random numbers, a corresponding random number was generated for each of the included study subjects, and the random numbers were sorted in ascending order of random numbers, serial numbers 1-22 were assigned to group 1, serial numbers 23-45 to group 2, and serial numbers 46-65 to group 3. 1, serial numbers 23-45 were assigned to group 2, and serial numbers 46-65 were assigned to group 3.

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：

本研究采用双盲法，随机化分配后，参与者和数据分析人员都是盲目的。每个运动干预组的参与者都接受了专门的训练。独立研究人员负责统计数据分析，并确保他或她不知道干预措施是如何分布的。

Blinding：

This study was double-blind, with participants and data analysts blinded after randomised allocation. Participants in each exercise intervention group received specialised training. The independent researcher was responsible for statistical data analysis and ensured that he or she was unaware of how the intervention was distributed.

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

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）：

通过论文的形式在相关期刊中共享，预计时间为2025年1月。

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

Shared in relevant journals through papers with an expected date of January 2025.

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：

实验测试数据由本人保存，暂无数据库保存。

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

The experimental test data is kept by me and no database is kept at the moment.

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：

  2024-11-08 09:50:56