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：	ChiCTR2200062061
最近更新日期： Date of Last Refreshed on：	2023-03-27 20:42:46
注册时间： Date of Registration：	2022-07-21 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于IMB模型的限制能量平衡膳食在中青年冠心病患者中的应用研究
Public title：	Application of IMB Model Based Calore Restrict Diet in Young and Middle-Aged Patients with Coronary Heart Disease
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于IMB模型的限制能量平衡膳食在中青年冠心病患者中的应用研究
Scientific title：	Application of IMB Model Based Calore Restrict Diet in Young and Middle-Aged Patients with Coronary Heart Disease
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：	秦璐	研究负责人：	王建辉
Applicant：	Lu Qin	Study leader：	Jianhui Wang
申请注册联系人电话： Applicant telephone：	+86 18830271606	研究负责人电话： Study leader's telephone：	+86 13832889907
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：	18830271606@139.com	研究负责人电子邮件： Study leader's E-mail：	anita30@163.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：	河北省唐山市路北区文化路27号	研究负责人通讯地址：	河北省唐山市路北区文化路27号
Applicant address：	27 Wenhua Road, Lubei District, Tangshan city, Hebei Province	Study leader's address：	27 Wenhua Road, Lubei District, Tangshan city, Hebei Province
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：	唐山市工人医院
Applicant's institution：	TANGSHAN GONGREN HOSPITAL
研究负责人所在单位：
Affiliation of the Leader：

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：	GRYY-LL-KJ2022-K69	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：	唐山市工人医院
Name of the ethic committee：	TANGSHAN GONGREN HOSPITAL
伦理委员会批准日期： Date of approved by ethic committee：	2022-04-20 00:00:00
伦理委员会联系人：	李莉
Contact Name of the ethic committee：	Li Li
伦理委员会联系地址：	唐山市路北区文化路27号
Contact Address of the ethic committee：	27 Wenhua Road, Lubei District, Tangshan city, Hebei Province
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

唐山市工人医院

Primary sponsor：

TANGSHAN GONGREN HOSPITAL

研究实施负责（组长）单位地址：

河北省唐山市路北区文化路27号

Primary sponsor's address：

27 Wenhua Road, Lubei District, Tangshan city, Hebei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	河北省	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	唐山市工人医院	具体地址：	河北省唐山市路北区文化路27号
Institution hospital：	TANGSHAN GONGREN HOSPITAL	Address：	27 Wenhua Road, Lubei District, Tangshan city, Hebei Province

经费或物资来源：

自筹

Source(s) of funding：

self-financing

研究疾病：

冠心病

Target disease：

coronary heart disease

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：

半随机对照

Study design：

Quasi-randomized controlled

研究目的：

本研究拟对中青年超重、肥胖冠心病患者进行以信息-动机-行为技能模型为理论依据的限制能量平衡膳食干预，以降低心血管危险因素，获得该方式在健康饮食方面的有效性及可行性的充分证据，促进中青年冠心病患者健康饮食行为形成。

Objectives of Study：

This study focuses on young and middle-aged overweight, obesity, coronary heart disease patients with skills in information - motivation - behavior model as the theoretical basis of limit energy balance dietary intervention, to reduce cardiovascular risk factors, for validity and feasibility of the method in the aspect of a healthy diet of sufficient evidence, to promote healthy eating behavior formation of young and middle-aged patients with coronary heart disease (CHD).

药物成份或治疗方案详述：

树立信念：1.向患者讲解冠心病患者不合理饮食的对疾病造成的危害。 2.利用关键证据向患者讲解合理膳食与健康的关系，使之了解益处。 3.因人而异地分析患者的行为特征和健康问题的特征，帮助其正确评价和判断自己的能力，使之意识到通过自身努力可以改变饮食情况的发生，树立采取合理膳食的信心。 4.向患者提供合理膳食给冠心病患者带来益处的相关视频，并向其家属介绍合理膳食的相关知识，利用他们的正面评价以促进患者采纳相关措施。传递信息，传授技巧：1.限制能量平衡膳食相关知识：概念与意义，并使用食物模型辅助讲解，让患者对食物的种类、重量、能量有直观的了解。以常见食物展示排序，并指导患者进行简单的食谱搭配。 2.能量平衡状态：概念及判断指标。 3.根据能量需要计算每日食物需要量。 4.食不过量的控制技巧：定时定量进餐；吃饭细嚼慢咽；分餐制；每顿少吃两口；减少高能量加工食品的摄入；减少在外就餐。学会技巧，明确目标：1.控制饮食技巧：“拳头法”、“手掌法则”。 2.饮食记录的意义及操作方法：3日饮食记录法、互联网饮食记录法、食物拍照记录法。 4.饮食合理性的评价指标：体重、BMI、腰围值。 5.制定个人减重计划，告知患者减重目标（3个月减重5%-10%），帮助患者明确目标建立信心。结合患者的环境资源和偏好，个体化指导患者，与患者及家属共同制定每两周的阶段目标。 6.要求患者每两周进行3日饮食记录，进行自我监督，提高患者自主需要。食盐与烹调油：1.食盐、烹调油与健康的关系及建议摄入量。 2.减盐技巧：学会量化、替代品、适量肉类、烹饪方法多样、少吃高盐零食。 3.减油技巧：定量巧烹饪、少吃油炸食品。 4.从食盐和烹调油两方面，与患者共同分析3日饮食记录，饮食中存在的问题给予指导。 5.让患者说出在改变过程中遇到的困难、阻碍执行正确行为的原因，及时给予应对策略，缓解患者的消极情绪，帮助患者建立信心。鱼禽蛋瘦肉：1.巩固鱼、禽、蛋、瘦肉每天建议摄入量相关知识。 2.适量摄入技巧：控制总量、小份量，量化有数。 3.从鱼、禽、蛋、瘦肉摄入情况，与患者共同分析3日饮食记录，饮食中存在的问题给予指导。 4.随访询问进展，是否达到阶段性目标，达到阶段性目标者微信群中进行总结，鼓励达成目标的患者；未达到目标者，与患者共同分析原因。平衡膳食，合理搭配：1.巩固平衡膳食相关概念，建议摄入的主要食物种类数、合理搭配相关概念、能量供应比例及食物来源相关知识。 2食物多样性小技巧：小份量多几样、同类食物常变化、不同食物巧搭配。 3.从食物多样性和合理搭配两方面，与患者共同分析3日饮食记录，饮食中存在的问题给予指导。 4.分析患者上次阶段性目标完成情况，并与患者共同制定下一个阶段性目标。能量平衡：1.巩固能量平衡状态的概念及判断指标 2.从能量需要量，与患者共同分析3日饮食记录，饮食中存在的问题给予指导。 3.随访询问进展，是否达到阶段性目标，达到阶段性目标者微信群中进行总结，鼓励达成目标的患者；未达到目标者，与患者共同分析原因，并给予相关的解决方法。蔬果与奶类：1.巩固蔬果、奶类在平衡膳食中的作用相关知识。 2.达到足量蔬果及奶制品目标量的技巧：餐餐有蔬菜、天天吃水果、蔬果巧搭配、多样奶制品选择。 3.从蔬果、奶类摄入情况，与患者共同分析3日饮食记录，饮食中存在的问题给予指导。 4.分析目前目标完成情况，与总目标进行对比。会烹会选：1.食品营养标签：配料表、营养成分表、利用营养声称选购食品。 2.设计一日三餐：了解和确定膳食能量摄取目标、挑选食物和用量。 3.烹饪方法推荐：多用蒸、煮、炒；少用煎、炸。 4.分析患者总目标完成情况，给予患者的饮食行为的肯定。第一次集体健康教育：1.限制能量平衡膳食：概念、益处、执行方法。 2.总结阶段性目标完成情况，以及患者在完成目标过程中的困难。 3.邀请目标完成较好的患者分享限制能量平衡膳食的饮食经验，并在微信群中上传一日三餐的图片，便于相互学习，让患者产生长期坚持的信念，提高依从性。第二次集体健康教育：1.饮食控制技巧：进餐方式、外卖及在外就餐技巧、工作食堂就餐技巧。 2.总结阶段性目标完成情况，以及患者在完成目标过程中的困难。 3.邀请目标完成较好的患者分享限制能量平衡膳食的饮食经验，并在微信群中上传一日三餐的图片，便于相互学习，让患者产生长期坚持的信念，提高依从性。

Description for medicine or protocol of treatment in detail：

Establish belief: 1. Explain to patients the harm caused by unreasonable diet in patients with coronary heart disease; 2. Use key evidence to educate patients about the benefits of proper diet and health; 3. Analyze the characteristics of patients' behavior and health problems from person to person, help them correctly evaluate and judge their own ability, make them realize that they can change the occurrence of their diet through their own efforts, and build up the confidence to take a reasonable diet; 4. Provide videos related to the benefits of a reasonable diet to patients with coronary heart disease, and introduce relevant knowledge of reasonable diet to their families, and use their positive comments to promote patients to adopt relevant measures; 1. Related knowledge of energy-restricted balanced diet: concepts and meanings, assisted by food models so that patients can have an intuitive understanding of the type, weight, and energy of food. Show the common food in order, and guide the patient to make a simple recipe. 2. Energy balance state: concept and judgment index. 3. Calculate your daily food requirements based on your energy needs. 4. Control skills of not overeating: regular and quantitative meals; Eat slowly; Separate eating; Eat two small bites at each meal; Cut down on energy-dense processed foods; Cut down on eating out. Learn skills, clear goals: 1. Control diet skills: "fist method", "palm rule". 2. Significance and operation method of food recording: 3-day food recording method, Internet food recording method, food photo recording method. 4. Evaluation indicators of diet rationality: weight, BMI and waist circumference. 5. Develop a personal weight loss plan, inform the patient of the weight loss goal (5%-10% weight loss in 3 months), and help the patient to clarify the goal and build confidence. Patients were guided individually according to their environmental resources and preferences, and biweekly goals were set together with patients and their families. 6. Patients are required to record their diet for 3 days every two weeks and conduct self-supervision to improve their independent needs. Salt and cooking oil: 1. The relationship between salt, cooking oil and health and the recommended intake. 2. Salt reduction techniques: Learn quantification, substitutions, proper amounts of meat, variety of cooking methods, and fewer high-salt snacks. 3. Oil reduction skills: quantitative cooking, less fried food. 4. Analyze the diet record of the third day with the patient in terms of salt and cooking oil, and give guidance on the problems in diet. 5. Let the patients tell the difficulties encountered in the process of change and the reasons that hinder the implementation of correct behaviors, and give timely coping strategies to relieve the negative emotions of the patients and help them build confidence. 1. Consolidate the knowledge of the recommended daily intake of fish, poultry, eggs and lean meat. 2. Moderate intake tips: Control the total amount, small portions, quantified. 3. From the intake of fish, poultry, eggs and lean meat, the patient and the patient jointly analyzed the 3-day diet record, and gave guidance on the problems existing in the diet. 4. Follow up and ask whether the progress has been achieved, summarize the progress in the wechat group of those who have achieved the stage goal, and encourage the patients who have achieved the goal; If the target was not reached, the reasons were analyzed together with the patients. 1. Consolidate the concepts related to balanced diet, including the recommended number of main food types, the concepts related to reasonable collocation, the proportion of energy supply and food sources. Food DIVERSITY TIPS: SMALL portions WITH a few more items, food of the same kind often changes, different food collocation. 3. From the perspective of food diversity and reasonable collocation, analyze the diet records of the third day together with the patients, and give guidance on the problems in diet. 4. Analyze the completion of the patient's last stage goal, and jointly formulate the next stage goal with the patient. Energy balance: 1. Consolidate the concept and judgment index of energy balance state 2. From the energy requirement, the patient and the patient jointly analyzed the 3-day diet record, and gave guidance on the problems in diet. 3. Follow up and ask whether the progress has been achieved, summarize in the wechat group of those who have achieved the stage goal, and encourage the patients who have achieved the goal; If the target is not achieved, analyze the reason together with the patient and give relevant solutions. Fruits and vegetables and milk: 1. Consolidate the knowledge about the role of fruits and vegetables and milk in a balanced diet. 2. Achieve sufficient amount of fruits and vegetables and dairy products target amount of skills: meals have vegetables, eat fruits every day, fruits and vegetables collocation, a variety of dairy products choice. 3. From the intake of vegetables, fruits and milk, analyze the diet records of the third day together with the patients, and give guidance on the problems existing in the diet. 4. Analyze the current goal completion and compare with the overall goal. 1. Food nutrition label: ingredients list, nutrition facts list, use nutrition claims to buy food. 2. Design three meals a day: Know and determine dietary energy intake targets, select foods and use amounts. 3. Recommended cooking methods: mostly steam, boil and stir-fry; Use less frying and frying. 4. Analyze the completion of patients' overall goals and give the affirmation of patients' eating behaviors. First Group Health EDUCATION: 1. Energy Restricted Balanced Diet: Concepts, Benefits, methods of implementation. 2. Summarize the achievement of phased goals and the difficulties of patients in the process of achieving goals. 3. Invite patients with good goals to share their dietary experience of restricted energy balanced diet, and upload pictures of three meals a day in the wechat group to facilitate mutual learning, so that patients can generate long-term belief and improve compliance. The second group health education: 1. Diet control skills: dining style, takeout and eating out skills, dining skills at work canteen. 2. Summarize the achievement of phased goals and the difficulties of patients in the process of achieving goals. 3. Invite patients with good goals to share their dietary experience of restricted energy balanced diet, and upload pictures of three meals a day in the wechat group to facilitate mutual learning, so that patients can generate long-term belief and improve compliance.

纳入标准：

Inclusion criteria

排除标准：

a 有严重食物过敏史；
b 有严重心律失常；
c 近一个月内体重下降>3%；
d 过去半年内或目前正在接受减肥治疗；
e 有严重肝肾功能不全或终末期疾病者；
f 活动性恶性肿瘤，有肢体障碍不能运动；

Exclusion criteria：

1. A history of severe food allergies;
2. The patient has a severe arrhythmia;
3. The patient lost more than 3% of body weight in the last month;
4. The patient has received weight loss treatment within the past six months or currently;
5. Patients with severe liver or kidney insufficiency or end-stage disease;
6. The patient has an active malignancy and a disability that prevents movement.

研究实施时间：

Study execute time：

从 From 2022-07-22 00:00:00至 To 2022-10-22 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2022-07-22 00:00:00 至 To 2022-08-22 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	33
Group：	control group	Sample size：	33
干预措施：	进行常规护理措施包括入院宣教、基础护理、饮食指导、用药护理、健康宣教、心理护理	干预措施代码：
Intervention：	Routine nursing measures include admission propaganda and education, basic nursing, dietary guidance, medication nursing, health propaganda and education, psychological nursing	Intervention code：

组别：	对照组	样本量：	33
Group：	control group	Sample size：	33
干预措施：	出院时给予病情观察、复诊时间等指导。	干预措施代码：
Intervention：	Upon discharge, the patient was instructed to observe the condition and time for return visit	Intervention code：

组别：	对照组	样本量：	33
Group：	control group	Sample size：	33
干预措施：	出院后从用药情况、低盐低脂饮食情况、心理情况、复查情况相关内容进行定时随访。	干预措施代码：
Intervention：	After discharge, regular follow-up was conducted from medication, low-salt and low-fat diet, psychological condition and review.	Intervention code：

组别：	干预组	样本量：	33
Group：	intervention group	Sample size：	33
干预措施：	院内对患者进行3次面对面的干预，3次主题分别为：树立信念、传递信息，传授技巧和学会技巧，明确目标	干预措施代码：
Intervention：	Three face-to-face interventions were carried out in the hospital. The themes of the three interventions were: establishing beliefs, transmitting information, teaching skills and learning skills, and clarifying goals	Intervention code：

组别：	干预组	样本量：	33
Group：	intervention group	Sample size：	33
干预措施：	院外对患者进行6次个性化健康教育，主题分别为：食盐与烹调油、鱼禽蛋瘦肉、平衡膳食，合理搭配、能量平衡、蔬果与奶类、会烹会选	干预措施代码：
Intervention：	Patients were given personalized health education for 6 times outside the hospital. The themes were: salt and cooking oil, lean meat of fish, poultry and eggs, balanced diet, reasonable collocation, energy balance, vegetables, fruits and milk, and good cooking	Intervention code：

组别：	干预组	样本量：	33
Group：	intervention group	Sample size：	33
干预措施：	每四周对患者进行一次集体健康教育，共2次	干预措施代码：
Intervention：	Patients were given group health education once every four weeks, a total of two times	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	河北省	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	唐山市工人医院	单位级别：	三级甲等
Institution hospital：	TANGSHAN GONGREN HOSPITAL	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	中国健康饮食指数	指标类型：	主要指标
Outcome：	China Healthy Eating Index(CHEI)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	西雅图心绞痛量表	指标类型：	次要指标
Outcome：	Seattle angina questionnaire	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	体重	指标类型：	次要指标
Outcome：	weight	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	身体质量指数	指标类型：	次要指标
Outcome：	Body Mass Index(BMI)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	腰围	指标类型：	次要指标
Outcome：	waistline	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		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：		测量方法：
Measure time point of outcome：		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：		测量方法：
Measure time point of outcome：		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：		测量方法：
Measure time point of outcome：		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：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	尿酸	指标类型：	次要指标
Outcome：	Uric Acid	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		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：		测量方法：
Measure time point of outcome：		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：		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	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	59	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）：

由研究者本人选取唐山某三甲医院心内科符合入组条件的中青年冠心病患者按照入院时间进行编号，运用SPSS 19.0软件1：1随机分为对照组和实验组，对应入组。具体操作步骤：①用EXCEL表生成1-80数字。②将其导入SPSS软件中进行随机分组，其固定值设置为2000000，生成数字表。③患者按照入院时间，符合纳入标准的患者按照编号顺序安排随机数字，属于数字0的患者进入对照组，属于数字1的患者进入干预组。为避免患者出现沾染（即恰巧干预组和对照组的患者在同一病房，可能互相交流影响实验结果），当遇到此种情况时，将其中1例对照组调为干预组，下次遇到同样情况时再将其中1例干预组调为对照组

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

Middle-aged and young patients with coronary heart disease in The Department of Cardiology of Tangshan Workers' Hospital were selected by the researcher and numbered according to the admission time. SPSS 19.0 software was used to randomly divide them into control group and experimental group 1:1, corresponding

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：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	随时公开，项目根据研究进程择期选择具体方式公开原始数据
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Real time access，According to the progress of the research，raw research data should be made freely available to all researchers in specific ways.
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：	研究者根据研究对象的原始数据，将数据及时，完整，正确，清晰地载入病例报告表。录入采用虚拟的数据库系统双人双机录入，之后对数据库进行两遍对比。电子数据文件分类保存，并有多个备份保存于不同磁盘或记录介质上，善于保存，防止损坏。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	According to the original data of the study subjects, the data were timely, complete, correct and clear in the case report form. Input using virtual database system double double machine input, after the database for two times comparison. Electronic data files are stored in different categories and have multiple backups on different disks or recording media to prevent damage.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2022-07-21 12:28:01