中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600125223
最近更新日期： Date of Last Refreshed on：	2026-05-22 14:55:40
注册时间： Date of Registration：	2026-05-22 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	新疆老年心血管代谢性共病患者营养行为数智化干预方案研究
Public title：	Study on a Digital-Intelligent Intervention Protocol for Nutritional Behaviors among Elderly Patients with Cardiometabolic Multimorbidity in Xinjiang
注册题目简写：
English Acronym：
研究课题的正式科学名称：	新疆老年心血管代谢性共病患者营养行为数智化干预方案研究
Scientific title：	Study on a Digital-Intelligent Intervention Protocol for Nutritional Behaviors among Elderly Patients with Cardiometabolic Multimorbidity in Xinjiang
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：	高晶	研究负责人：	杜艳伟; 高晶
Applicant：	Jing Gao	Study leader：	Yanwei Du; Jing Gao
申请注册联系人电话： Applicant telephone：	+86 991 436 2671	研究负责人电话： Study leader's telephone：	+86 431 8561 9559
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：	xydyfy_gaojing@126.com	研究负责人电子邮件： Study leader's E-mail：	duyw@jlu.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：	新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号	研究负责人通讯地址：	吉林省长春市朝阳区新疆街965号
Applicant address：	No. 137, Liyushan Road, Urumqi City, Xinjiang Uygur Autonomous Region	Study leader's address：	965, Xinjiang Street, Chaoyang District, Changchun, Jilin
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：	吉林大学护理学院; 新疆医科大学第一附属医院
Applicant's institution：	School of Nursing Jilin University; First Affiliated Hospital of Xinjiang Medical University
研究负责人所在单位：	吉林大学护理学院; 新疆医科大学第一附属医院
Affiliation of the Leader：	School of Nursing Jilin University; First Affiliated Hospital of Xinjiang Medical University

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：	2026012103; K202601-98	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：	吉林大学护理学院伦理委员会；新疆医科大学第一附属医院医学伦理委员会
Name of the ethic committee：	Ethics Committee of the School of Nursing Jilin University; Medical Ethics Committee of the First Affiliated Hospital of Xinjiang Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2026-01-30 00:00:00
伦理委员会联系人：	鲁晓擘
Contact Name of the ethic committee：	Xiaobo Lu
伦理委员会联系地址：	新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号
Contact Address of the ethic committee：	No. 137, Liyushan Road, Urumqi City, Xinjiang Uygur Autonomous Region
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 991 436 2671	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：

吉林大学护理学院; 新疆医科大学第一附属医院

Primary sponsor：

School of Nursing Jilin University; First Affiliated Hospital of Xinjiang Medical University

研究实施负责（组长）单位地址：

新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号

Primary sponsor's address：

No. 137, Liyushan Road, Urumqi City, Xinjiang Uygur Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	新疆维吾尔自治区	市(区县)：
Country：	China	Province：	Xinjiang Uygur Autonomous Region	City：
单位(医院)：	新疆医科大学第一附属医院	具体地址：	新疆维吾尔自治区乌鲁木齐市鲤鱼山路137号
Institution hospital：	First Affiliated Hospital of Xinjiang Medical University	Address：	No. 137, Liyushan Road, Urumqi City, Xinjiang Uygur Autonomous Region

国家：	中国	省(直辖市)：	吉林	市(区县)：
Country：	China	Province：	Jilin	City：
单位(医院)：	吉林大学护理学院	具体地址：	吉林省长春市朝阳区新疆街965号
Institution hospital：	School of Nursing Jilin University	Address：	965, Xinjiang Street, Chaoyang District, Changchun, Jilin

经费或物资来源：

中华护理学会科研课题（ZHKYQ202523）资助

Source(s) of funding：

Scientific Research Project of the Chinese Nursing Association (ZHKYQ202523)

研究疾病：

心血管代谢性共病

Target disease：

Cardiovascular metabolic comorbidities

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：

整群随机分组

Study design：

Cluster randomization

研究目的：

开发并初步验证一套理论促进、循证为本、数智化技术可实践的《老年CMM患者营养行为干预方案》，旨在有效转变并长期维持新疆地区老年心血管代谢性共病患者的主动健康营养行为，为破解“医院-社区-家庭”营养管理服务链断裂与“知-行断层”困境提供科学、可行、可推广的解决方案。 1. 揭示新疆地区老年CMM患者营养行为的潜在类别，深入阐明驱动行为转变与长期维持的关键影响因素。 2. 整合行为驱动因素与最佳证据，构建《老年CMM患者营养行为转变方案》，并搭载至数智化系统。 3. 评价《方案》在改善患者营养行为依从性、主动健康能力及心血管代谢性生理指标方面的有效性，临床可行性与用户接受度。

Objectives of Study：

To develop and preliminarily validate a theory-driven, evidence-based, and digitally-enabled "Nutritional Behavior Intervention Program for Elderly Patients with CMM," aimed at effectively transforming and sustainably maintaining proactive healthy nutritional behaviors among elderly patients with cardiovascular and metabolic comorbidities in the Xinjiang region. This initiative seeks to provide a scientific, feasible, and scalable solution to address the disconnect in the "hospital-community-home" nutritional management service chain and the "knowledge-action gap." 1. Identify the underlying categories of nutritional behaviors among elderly CMM patients in the Xinjiang region and thoroughly elucidate the key factors driving behavioral change and long-term maintenance. 2. Integrate behavioral determinants with best evidence to develop the "Nutritional Behavior Transformation Protocol for Elderly Patients with CMM" and implement it within a digital and intelligent system. 3. Evaluate the protocol’s effectiveness in improving patient adherence to nutritional behaviors, proactive health management capabilities, and cardiovascular and metabolic physiological indicators, as well as its clinical feasibility and user acceptance.

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：

患有严重精神障碍或语言沟通表达受限。

Exclusion criteria：

Suffering from severe mental disorders or having limited language communication and expression abilities.

研究实施时间：

Study execute time：

从 From 2026-05-25 00:00:00至 To 2027-04-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-25 00:00:00 至 To 2027-04-30 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	84
Group：	intervention group	Sample size：	84
干预措施：	在常规护理基础上，从入院开始接受为期3个月的数智化《方案》干预。在患者入院当日，由责任护士协助患者及家属完成APP账户注册、基线信息录入，并指导其使用核心功能及开启消息提醒。在患者出院当天，录入患者出院时的身高、体重、糖脂代谢指标、用药等，设定目标值并计算每日饮食摄入总热量及三大营养素具体摄入量，要求患者对每日三餐饮食进行APP拍照打卡。	干预措施代码：
Intervention：	On the basis of routine care, patients began to receive a three-month digital and intelligent "Program" intervention from the day of admission. On the day of admission (T0), the responsible nurse assisted the patient and their family in completing the registration of the APP account, entering the baseline information, and guiding them on how to use the core functions and enable message reminders. On the day of discharge, the height, weight, glycolipid metabolism indicators, and medication of the patient at discharge were recorded, the target values were set, and the total daily calorie intake and specific intake of the three major nutrients were calculated. The patients were required to take photos of their three daily meals through the APP for check-in.	Intervention code：

组别：	对照组	样本量：	84
Group：	control group	Sample size：	84
干预措施：	接受研究医院现有的常规护理与健康教育。	干预措施代码：
Intervention：	Receive the routine care and health education currently provided by the study hospital.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	新疆维吾尔自治区	市(区县)：
Country：	China	Province：	Xinjiang Uygur Autonomous Region	City：
单位(医院)：	新疆医科大学第一附属医院	单位级别：	三甲
Institution hospital：	First Affiliated Hospital of Xinjiang Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	营养行为依从性	指标类型：	主要指标
Outcome：	Nutritional behavior compliance	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	主动健康能力	指标类型：	主要指标
Outcome：	The ability of proactive health management	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	临床生理指标	指标类型：	主要指标
Outcome：	Clinical physiological indicators	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	营养素养	指标类型：	次要指标
Outcome：	Nutrition literacy	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	自我效能	指标类型：	次要指标
Outcome：	self-efficiency	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生活质量	指标类型：	次要指标
Outcome：	living quality	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：	无	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	60	岁 years
最大 Max age	90	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）：

由不参与干预实施及结局评价的独立统计人员，使用SAS 9.4软件生成随机序列，以病区为随机化单位，将研究医院的4个心血管内科病区按1:1比例整群随机分配至干预组（2个病区）或对照组（2个病区）。分配结果密封保存，研究启动时统一揭晓。干预组病区患者接受数智化方案干预，对照组病区患者接受常规护理与健康教育。

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

An independent statistician not involved in the intervention implementation or outcome evaluation used SAS 9.4 software to generate the random sequence. The four cardiology wards in the study hospital were randomly assigned in a 1:1 ratio to the intervention group (2 wards) or the control group (2 wards) with wards as the randomization unit. The allocation results were sealed and kept confidential until the study was initiated, when they were revealed uniformly. Patients in the intervention group wards received the digital intervention program, while those in the control group wards received routine care and health education.

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：

本研究采用单盲设计。受干预措施性质所限，干预实施护士无法施盲。具体盲法措施如下： 1. 患者盲：两组患者均被告知参与"心血管疾病营养管理研究"，仅知晓本组干预内容，不被告知具体分组信息及另一组的干预方式。 2. 数据分析者盲：数据库中以编码（如A组、B组）替代实际组别名称，数据分析人员在完成全部统计分析并锁定结果后方可揭盲。

Blinding：

This study adopted a single-blind design. Due to the nature of the intervention measures, the nurses implementing the intervention could not be blinded. The specific blinding measures are as follows: 1. Patient blinding: Both groups of patients were informed that they were participating in the "Cardiovascular Disease Nutrition Management Study", and only knew the intervention content of their own group, without being informed of the specific group information or the intervention method of the other group. 2. Data analyst blinding: In the database, actual group names were replaced with codes (such as Group A, Group B). Data analysts could only unblind after completing all statistical analyses and locking the results.

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）：	以论文的方式公开
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Publish in the form of a 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：	1. 数据采集两组患者均于入院当天、出院后1周、干预结束时、干预结束后3个月四个时间点采集数据。量表类数据由经统一培训的评估人员通过问卷收集；临床生理指标从医院电子病历系统及门诊复查记录中提取；膳食质量数据由APP后台AI识别记录自动导出；APP使用日志数据由后台系统直接导出。 2. 数据管理采用EpiData数据管理系统建立数据库，实行双人双录入并进行逻辑校验。原始数据与分析数据分开存储，数据库设置权限管理，仅授权研究人员可访问。所有数据均去标识化处理，以受试者编号替代个人身份信息。数据录入完成并经核查无误后锁定数据库，锁定后不可修改。纸质资料由研究者保存，电子数据定期备份。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	1. Data collection Data were collected from both groups of patients at four time points: on the day of admission, one week after discharge, at the end of the intervention, and three months after the intervention. Scale data were collected through questionnaires by trained assessors; clinical physiological indicators were extracted from the hospital's electronic medical record system and outpatient follow-up records; dietary quality data were automatically exported from the AI recognition records in the APP's background; and APP usage log data were directly exported from the background system. 2. Data management The EpiData data management system was used to establish a database, with double data entry and logical verification by two people. Raw data and analysis data were stored separately, and the database had permission management, allowing only authorized researchers to access it. All data were de-identified, with subject numbers replacing personal identity information. After data entry was completed and verified to be error-free, the database was locked and could not be modified. Paper materials were kept by the researchers, and electronic data were backed up regularly.
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：	2026-05-22 14:55:12