ChiCTR2500100310 版本V1.0 版本创建时间2025/04/07 18:26:51 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：

ChiCTR2500100310 

最近更新日期：

Date of Last Refreshed on：

2025-04-07 18:26:42 

注册时间：

Date of Registration：

2025-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于智能手机体重管理软件的生活方式干预对超重/肥胖人群减重与代谢状态改善的影响

Public title：

Effect of Smartphone-Based Remote Interventions on Weight Control and Related Metabolic Benefits in Overweight and Obese Primary Care Patients in China: A Randomized, Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于智能手机体重管理软件的生活方式干预对超重/肥胖人群减重与代谢状态改善的影响

Scientific title：

Effect of Smartphone-Based Remote Interventions on Weight Control and Related Metabolic Benefits in Overweight and Obese Primary Care Patients in China: 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：

梁瀚丹 

研究负责人：

周后德 

Applicant：

Handan Liang 

Study leader：

Houde Zhou 

申请注册联系人电话：

Applicant telephone：

+86 159 7310 1789

研究负责人电话：

Study leader's telephone：

+86 731 8529 2223

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：

danhanlia@163.com

研究负责人电子邮件：

Study leader's E-mail：

houdezhou@csu.edu.cn

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：

中国湖南省长沙市人民中路139号

研究负责人通讯地址：

中国湖南省长沙市人民中路139号

Applicant address：

139 Middle Remin Road, Changsha, Hunan, China

Study leader's address：

139 Middle Remin Road, Changsha, Hunan, China

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：

中南大学湘雅二医院

Applicant's institution：

The Second Xiangya Hospital of Central South University

研究负责人所在单位：

中南大学湘雅二医院

Affiliation of the Leader：

The Second Xiangya Hospital of Central South University

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：

(2024)国伦审[科]第(047)号

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：

中南大学湘雅二医院国家临床医学研究中心伦理委员会

Name of the ethic committee：

Ethics Committee of National Clinical Medical Research Center, Second Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-08-01 00:00:00

伦理委员会联系人：

贺敏

Contact Name of the ethic committee：

He Min

伦理委员会联系地址：

中国湖南省长沙市人民中路139号

Contact Address of the ethic committee：

139 Middle Remin Road, Changsha, Hunan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 731 8529 5391

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：

中南大学湘雅二医院

Primary sponsor：

The Second Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市人民中路139号

Primary sponsor's address：

139 Middle Remin Road, Changsha, Hunan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅二医院

具体地址：

人民中路139号

Institution
hospital：

The Second Xiangya Hospital of Central South University

Address：

139 Middle Remin Road

经费或物资来源：

自筹

Source(s) of funding：

self-raised project funds

Target disease：

Overweight/Obesity

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

以单独进行常规生活方式管理为对照，观察智能手机体重管理小程序“德教瘦”联合常规生活方式管理对超重/肥胖人群的减重和代谢改善情况。  

Objectives of Study：

To observe the weight loss and metabolic improvement of overweight/obese people in comparison with conventional lifestyle management alone, the smartphone weight management app "De Jiaoshou" combined with conventional lifestyle management.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1、自愿参加并签署知情同意书 2、年龄≥18 岁，男女不限 3、 BMI≥24 kg/m2 4、会使用计算机、平板电脑或智能手机等设备且互联网访问无限制 5、有减重意愿

Inclusion criteria

1. Voluntarily to participate and sign the informed consent form; 2. Age >= 18 years old, male or female; 3, BMI >= 24 kg/m^2; 4. Able to use a device such as a computer, tablet or smartphone with unlimited Internet access; 5. Willing to lose weigh

排除标准：

1、各种原因引起的继发性肥胖：：如下丘脑-垂体病变、库欣综合征、甲状腺功能减退 等；医源或药物性肥胖等，常见有抗精神病药物、皮质类固醇药物 2、有明确病因的肥胖综合征（如 PWS 等） 3、处于妊娠或哺乳期，或在未来 6 个月有怀孕计划的女性 4、酗酒者（女性摄入酒精>40 克/天（2 两白酒），男性摄入酒精>80 克/天） 5、严重心脑血管疾病（如过去 6 个月有心衰、心肌梗塞、脑梗塞、急性心肌炎、严 重心律不齐、接受介入式疗法者等）或三期高血压（使用三种降压药不能将收缩压控制 在 160 mmHg 以下）、严重肝肾功能疾病（谷丙转氨酶、血清肌酐指标超出医院设定的 正常值范围 4 倍）、恶性肿瘤及血液病患者等不耐受减重或患有减重禁忌的严重疾病者 6、乙肝大三阳、活动性肺结核、艾滋病等传染性疾病 7、身体活动能力受损者或因疾病及治疗等原因体力活动受限者 8、近期体重无明显原因（如未进行减重干预）突然变化较大（3 个月内 >= 5kg） 9、患有影响消化吸收的慢性胃肠道疾病，如炎症性肠病或乳糜泻等 10、 有确诊的饮食失调史和/或自我报告的饮食失调史的患者，如暴食症等 11、服用可能使体重变化的药物，并且不愿意或不能在实验期内推迟使用这些药物的治疗。可能导致体重减轻的药物： 奥利司他、GLP-1 受体激动剂、纳曲酮/安非他酮、芬特明/托吡酯等及其他减肥药。 如果患者使用减肥药物停止＞1 个月，他们仍视为符合资格。可能导致体重增加的药物： 抗精神分裂症药物（如氯丙嗪等）、抗抑郁药（如阿米替林等）、抗癫痫药（如丙戊酸等）、皮质类固醇、 抗组胺药、避孕药、胰岛素等。 12、过去 6 个月或当前实行全流质饮食计划的患者。如果患者实行全流质饮食计划后已恢复正常饮食，他们仍视为符合资格。 13、减肥手术史或预计在研究期间实行减重手术者 14、有精神疾患、不能很好合作者 15、计划在研究期间搬迁到无法进行后续随访地区患者 16、研究者认为不适合入组的其它情况

Exclusion criteria：

1. Secondary obesity caused by various reasons: the following thalamo-pituitary lesions, Cushing's syndrome, hypothyroidism, etc. Iatrogenic or drug-induced obesity, such as antipsychotic drugs and corticosteroids, are common 2. Obesity syndrome with definite etiology (such as PWS) 3. Women who are pregnant or breastfeeding, or who plan to become pregnant in the next 6 months 4. Alcoholics (women consume alcohol >40 g/day (2 two liquor), men consume alcohol >80 g/day) 5, severe cardio-cerebrovascular disease (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, receiving interventional therapy in the past 6 months) or stage III hypertension (systolic blood pressure cannot be controlled at 160 mmHg with three antihypertensive drugs) The following), severe liver and kidney function diseases (alanine aminotransferase, serum creatinine index more than 4 times the normal range set by the hospital), malignant tumor and blood disease patients who are intolerant to weight loss or have contraindications to weight loss 6, hepatitis B three positive, active tuberculosis, AIDS and other infectious diseases 7. Those with impaired physical activity ability or limited physical activity due to disease and treatment 8. Sudden weight change (>= 5kg within 3 months) without obvious reasons (such as no weight loss intervention) 9. Suffer from chronic gastrointestinal diseases that affect digestion and absorption, such as inflammatory bowel disease or celiac disease 10, patients with a history of a confirmed eating disorder and/or a self-reported history of an eating disorder, such as binge eating disorder, etc 11, taking medications that may cause weight change and being unwilling or unable to delay treatment with these medications for the duration of the trial. Drugs that may cause weight loss: orlistat, GLP-1 receptor agonists, naltrexone/bupropion, phentermine/topiramate, etc., and other weight-loss drugs. Patients were still considered eligible if they had stopped using weight-loss medications for > 1 month. Drugs that may cause weight gain: anti-schizophrenia drugs (such as chlorpromazine, etc.), antidepressants (such as amitriptyline, etc.), antiepileptic drugs (such as valproic acid, etc.), corticosteroids, antihistamines, contraceptives, insulin, etc. 12, patients on a whole fluid diet plan in the past 6 months or currently. Patients were considered to be eligible if they had returned to a normal diet after the implementation of the whole-fluid diet plan. 13, previous bariatric surgery or expected to undergo bariatric surgery during the study period 14. Have mental illness and cannot cooperate well 15, patients who plan to relocate to an area where subsequent follow-up is not available during the study period 16. Other conditions considered by the investigator to be inappropriate for enrollment

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2025-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-04-10 00:00:00 至 To 2025-10-30 00:00:00  

干预措施：

Interventions：

组别：

常规生活方式管理组

样本量：

330

Group：

usual primary care group

Sample size：

干预措施：

入组时该组受试者接受社区健康中心医生的常规评估，社区健康中心医生、营养师、护理人员根据检测指标并结合患者饮食运动习惯，共同提出生活方式干预建议。受试者要求在入组后第 3、6 个月至社区健康中心随访并复查相关指标，期间可随时向社康中心医师、营养师或护理人员咨询减重相关问题（包括面对面、电话或微信等方式）。定期举行健康教育宣讲，增强受试者对肥胖及相关并发症或合并症的知晓，提高对健康减重的认识。记录该组受试者健康咨询和参加宣讲的次数。干预期间患者不得使用体重管理软件。共干预 6 个月。

干预措施代码：

Intervention：

At the time of enrollment, the participants received routine assessment by doctors in community health centers. Doctors, dietitians and nurses in community health centers jointly proposed lifestyle intervention suggestions according to the test indicators and patients' diet and exercise habits. Participants were asked to visit the community health center at the 3rd and 6th month after enrollment to review the related indicators. During the follow-up, they could consult the doctors, dietitians, or nurses at the community health center at any time (face to face, by telephone, or by wechat). Regular health education was conducted to enhance the awareness of obesity and related complications or complications, and to improve the awareness of healthy weight loss. The Times of health consultation and lectures were recorded. Patients were not allowed to use weight-management software during the intervention. The intervention lasted for 6 months.

Intervention code：

组别：

智能手机管理小程序组

样本量：

330

Group：

Smartphone-Based Remote Intervention group

Sample size：

干预措施：

该组患者在接受与常规管理组相同干预的基础上，使用智能手机体重管理小程序“德教瘦”进行干预。在基线访问时，该组受试者将接受使用软件的培训，干预 1 周后电话随访软件的使用情况。受试者每天坚持使用“德教瘦”不少于 15 分钟，推荐执行软件提供的饮食运动方案，要求受试者记录每日执行情况与体重变化数据，根据“德教瘦”管理软件估算自己摄入和消耗的能量，并进行登记反馈。每日执行情况数据和体重变化数据可通过软件提供至社康中心医师，以方便社康中心医生了解其负责的患者的依从情况并进行监督。记录该组受试者健康咨询和参加宣讲的次数。为防止组间沾染，只对联合组进行软件授权（区域性授权与个人手机注册）。研究期间，受试者不得使用其他体重管理软件。受试者入组后开始干预，干预时间为 6 个月。

干预措施代码：

Intervention：

The patients in the group received the same intervention as the conventional management group, and the smartphone-based weight management program "De Jiaoshou" was used for intervention. At the baseline visit, this group of subjects will receive training in the use of the software, and the use of the software will be followed up by telephone 1 week after the intervention. The participants insisted on using "De Jiaoshou" for at least 15 minutes every day, and were recommended to implement the diet and exercise program provided by the software. The participants were asked to record their daily implementation and weight change data, and estimate their energy intake and expenditure according to "De Jiaoshou" management , and register feedback. Daily performance data and weight change data can be provided to community health center physicians through the software, so that community health center physicians can understand and monitor their patients' adherence. The times of health consultation and lectures were recorded. To prevent inter-group contamination, the applet authorization (regional authorization and personal phone registration) is only applied to the smartphone-based remote intervention groupp. Subjects were not allowed to use other weight management software during the study. The intervention began after the subjects were enrolled and lasted for 6 months.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 深圳 

Country：

China 

Province：

Guangdong 

City：

Shenzhen 

单位(医院)：

深圳市第二人民医院 

单位级别：

三甲 

Institution
hospital：

Shenzhen Second People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

体重

指标类型：

主要指标

Outcome：

weight

Type：

Primary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

体重秤

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

weighing scale

指标中文名：

腰围

指标类型：

次要指标

Outcome：

waist circumference

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

软尺

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

tape measure

指标中文名：

臀围

指标类型：

次要指标

Outcome：

hip circumference

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

软尺

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

tape measure

指标中文名：

腹部矢状径

指标类型：

次要指标

Outcome：

Sagittal diameter of abdomen

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

软尺

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

tape measure

指标中文名：

身高

指标类型：

附加指标

Outcome：

height

Type：

Additional indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

身高测量仪

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

Height measuring instrument

指标中文名：

血压

指标类型：

次要指标

Outcome：

blood pressure

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

血压计

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

sphygmomanometer

指标中文名：

脂肪含量（体脂率、总脂肪含量、腹部皮下脂肪 含量、内脏脂肪含量）

指标类型：

次要指标

Outcome：

Fat content (body fat percentage, total fat content, abdominal subcutaneous fat content, visceral fat content)

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

双能X线

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

DEXA

指标中文名：

脂肪肝程度B超诊断

指标类型：

次要指标

Outcome：

B-ultrasound diagnosis of fatty liver degree

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

B超

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

B-ultrasound

指标中文名：

自我效能评分

指标类型：

次要指标

Outcome：

Self-efficacy score

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

自我效能问卷

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

Self-efficacy questionnaire

指标中文名：

依从性评估

指标类型：

次要指标

Outcome：

Compliance evaluation

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

问卷

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

questionnaire

指标中文名：

肥胖相关知识评分

指标类型：

次要指标

Outcome：

Obesity-related knowledge score

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

问卷

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

questionnaire

指标中文名：

空腹血糖

指标类型：

次要指标

Outcome：

fasting blood-glucose

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

糖化血红蛋白

指标类型：

次要指标

Outcome：

Glycated hemoglobin

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

C 肽

指标类型：

次要指标

Outcome：

C-peptide

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

肌酐

指标类型：

次要指标

Outcome：

creatinine

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

尿素氮

指标类型：

次要指标

Outcome：

urea nitrogen

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

血清尿酸

指标类型：

次要指标

Outcome：

serum uric acid

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

谷草转氨酶

指标类型：

次要指标

Outcome：

Aspartate aminotransferase

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

谷丙转氨酶

指标类型：

次要指标

Outcome：

Alanine aminotransferase

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

γ-谷氨酞转移酶

指标类型：

次要指标

Outcome：

Gamma-glutamyl transferase

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

血清总蛋白

指标类型：

次要指标

Outcome：

total serum protein

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

血清白蛋白

指标类型：

次要指标

Outcome：

serum albumin

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

胆红素

指标类型：

次要指标

Outcome：

bilirubin

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

C反应蛋白

指标类型：

次要指标

Outcome：

C-reactive protein

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

甘油三酯

指标类型：

次要指标

Outcome：

triglyceride

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

总胆固醇

指标类型：

次要指标

Outcome：

total cholesterol

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

低密度脂蛋白

指标类型：

次要指标

Outcome：

low density lipoprotein

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

指标中文名：

高密度脂蛋白

指标类型：

次要指标

Outcome：

high-density lipoprotein

Type：

Secondary indicator

测量时间点：

入组时、干预后3个月、干预后6个月

测量方法：

Measure time point of outcome：

At enrollment, 3 months after intervention, and 6 months after intervention

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

全血

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 18 岁 years
最大 Max age 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）：

统计人员利用随机数生成函数为每名患者生成一个大于0且小于1的随机数，每个随机数均不重复；2）将大于等于0.5的随机数对应的患者分配到干预组，剩余的患者为对照组。

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

The statistician used a random-number generating function to generate a random number that was greater than 0 and less than 1 for each patient, with no repetition of each random number. 2) The patients corresponding to a random number greater than or equal to 0.5 were assigned to the intervention group, and the remaining patients were assigned to the control group.

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：

随机分配人员对受试者一般资料及基线数据并不知晓。因干预措施为基于智能手机应用程序的生活方式管理和常规生活方式管理，故不能对受试者设置盲法；因需要对干预组智能手机应用程序依从性进行调查，故不能对研究调查者设置盲法。为了减少偏倚，临床参数测量人员对组的分配情况并不知情。分析数据时，每位受试者将由一个随机数识别，分析数据人员对数据收集和数据输入不知情。

Blinding：

The personnel who randomly assigned the subjects were unaware of the general information and baseline data of the subjects. Because the interventions were smartphone-based lifestyle management and usual lifestyle management, the participants could not be blinded. The need to investigate adherence to the smartphone app in the intervention group precluded blinding of the trial investigators. To minimize bias, clinical parameter measurements were blinded to group assignments. For data analysis, each subject will be identified by a random number, and the data analyser will be blinded to data collection and data entry.

是否共享原始数据：

IPD sharing

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）：

以学术论文形式公开

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

Published as an academic paper

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：

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）

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

One is the case record form, and the other is the electronic collection and management system.

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：

  2025-04-07 18:26:42