Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.
This is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness.
200 participants aged 35-74 years who have intermediate cardiovascular risk will be included.
Subjects will be selected by consecutive sampling at urban primary care health centers from Salamanca (Spain) and they will be randomized to a control or an intervention group.
Both groups will receive individual standardized counselling on healthy diet, daily physical activity, smoking cessation, and moderation in alcohol consumption.
Moreover, individuals from the intervention group will receive additional group counselling and follow-up calls.
The effect of the intervention will be assessed using lifestyles and quality of life questionnaires, metabolic control parameters, inflammation markers, anthropometric and vascular function measurements, and neuropsychological tests.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
203
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Castilla And Leon
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Salamanca、Castilla And Leon、西班牙、37003
- Primary Care Research Unit, The Alamedilla Health Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 至 74年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.
Exclusion Criteria:
- Personal history of atherosclerotic disease.
- Unable to do exercise or follow the Mediterranean diet.
- Institutionalized.
- Terminal illness.
- Mental disorders that limited the intervention compliance.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Control group
Individual counselling on lifestyles.
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Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
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实验性的：Intervention group
Individual counselling on lifestyles and additional group counselling on lifestyles.
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Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Group sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed. Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adherence to the Mediterranean diet
大体时间：1 year
|
Measurement by validated 14-point Mediterranean Diet Adherence Screener
|
1 year
|
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Self-reported physical activity
大体时间：1 year
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Measurement by short version of the International Physical Activity Questionnaire
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in physical activity
大体时间：1 year
|
Measurement by Pedometer
|
1 year
|
|
Changes in dietary pattern
大体时间：1 year
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Measurement by semi-quantitative Food Frequency Questionnaire
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1 year
|
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Cardiovascular risk factors
大体时间：1 year
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Measurement by Framingham Risk Score
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1 year
|
|
Body composition
大体时间：1 year
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Measurement by Bioelectrical Impedance Analyzer
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1 year
|
|
Cardio-ankle vascular index (CAVI)
大体时间：1 year
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Measurement by Vasera® VS-2000 device
|
1 year
|
|
Brachial-ankle pulse wave velocity (ba-PWV)
大体时间：1 year
|
Measurement by Vasera® VS-2000 device
|
1 year
|
|
Ankle-brachial index (ABI)
大体时间：1 year
|
Measurement by Vasera® VS-2000 device
|
1 year
|
|
Health related quality of life
大体时间：1 year
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Measurement by Spanish version of the SF-12 questionnaire
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1 year
|
|
Immediate verbal memory
大体时间：1 year
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Assessment by immediate recall of a list of 15 words, in three attempts
|
1 year
|
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Delayed verbal memory
大体时间：1 year
|
Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes
|
1 year
|
|
Phonological fluency
大体时间：1 year
|
Assessment by enumerating for one minute as many words as possible starting with different letters
|
1 year
|
|
Attention
大体时间：1 year
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Assessment by Trail Making Test A
|
1 year
|
|
Processing speed
大体时间：1 year
|
Assessment by Trail Making Test B
|
1 year
|
|
Executive functions
大体时间：1 year
|
Assessment by Trail Making Test B
|
1 year
|
|
Working memory
大体时间：1 year
|
Assessment by WAIS Digit Span Backward test
|
1 year
|
|
Sustained attention
大体时间：1 year
|
Assessment by Stroop test
|
1 year
|
|
Selective attention
大体时间：1 year
|
Assessment by Stroop test
|
1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Sara Mora Simón, PhD、Primary Care Research Unit, The Alamedilla Health Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月1日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2019年3月31日
研究注册日期
首次提交
2017年5月22日
首先提交符合 QC 标准的
2017年5月22日
首次发布 (实际的)
2017年5月23日
研究记录更新
最后更新发布 (实际的)
2019年4月16日
上次提交的符合 QC 标准的更新
2019年4月12日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.