Diet Therapy Versus Prescriptive Educational Group Intervention in Overweight / Obese Patients at First Episode of AMI: a Randomized Controlled Trial
Results after interventions on lifestyle in the secondary prevention of ischemic heart disease are not always consistent, and the Guidelines multidisciplinary measures aren't easily achievable.
Therefore, the purpose of this research project is the identification of an interventional approach to effective secondary prevention and realistic feasibility, in a field of multifactorial risk. The study is open to patients who totaled a double chronic disease, obesity/overweight and coronary heart disease, and who experienced a first event of ischemic cardiac infarction (AMI). The aim is to evaluate the effectiveness of a group educational intervention in a sample of overweight and obese patients (BMI > 24.9) incurred in a first episode of acute myocardial infarction (non-STEMI and STEMI), comparing with the classic approach of prescriptive diet therapy.
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Pavia、意大利、27100
- 招聘中
- Cardiology Department
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接触：
- Arturo Raisaro, MD
- 电话号码：+39 0382 502587
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PV
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Pavia、PV、意大利、27100
- 招聘中
- Internal Medicine Department, Clinica Medica II, IRCCS San Matteo Foundation
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接触：
- Chiara Muggia, MD
- 电话号码：+39 0382 502190
- 邮箱：c.muggia@smatteo.pv.it
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首席研究员：
- Chiara Muggia, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Subjects of both sexes and age ≥ of 18 years consecutively admitted to the Coronary Unit of IRCCS Foundation Policlinico S. Matteo, at first episode of STEMI or non-STEMI AMI, with BMI greater than 24.9.
Exclusion Criteria:
Patients who can not provide informed consent (because illiterate or with significant language barrier or severe deficit/cognitive decays). Subjects with diseases and/or disabling organ damage. Subjects affected by active neoplasm. Individuals who have submitted arhythmic complications in acute and/or heart failure, or people referring to post-AMI residential rehabilitation. Subjects that are carriers of severe psychiatric disorders diagnosed by DSM-V -TR.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：educational group intervention
The group educational food intervention: it provides the delivery of information leaflet and inclusion in groups on a weekly basis for the first 3 meetings, and then, there are other 2 meetings on the third and sixth month by the AMI. The meetings will cover education to self-nutrition, physical activity and learning techniques for stimulus control and management of high-risk situations. |
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有源比较器：prescriptive diet
An objectives food scheme elaborated for each patients will provide the reduction in caloric intake (equivalent to 500-600 calories in deficit if compared to the estimated daily requirement, based on the RDAs) and a reduced intake of lipids, which does not exceed 30% of total calories introduced, with a contribution of saturated fat no more than 7-9% .
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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 |
|---|---|---|
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reduction of body weight
大体时间：6 months
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The proportion of subjects with a 10% reduction in body weight at 6 months
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Reduction of reinfarction and revascularization
大体时间：1 year
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1 year
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general and specific mortality
大体时间：1 year
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relative risk of death from all causes and from ischemic heart disease (no. of overall deaths and cardiovascular causes).
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1 year
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quality of life
大体时间：6 months
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quality of life (assessed by SF-36 questionnaire at baseline and 6 months after infarction).
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6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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