Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial. Effectiveness of a Program Using Cognitive Behavioral Therapy to Improve Healthy Habits in a Population With Cardiovascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Consumption of fruits and vegetables
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a program to improve habits in a population with cardiovascular disease, comparing two different educational techniques (cognitive behavioral therapy group vs. informational workshops).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who live in the catchment area of the health centers participating in the trial or that have their primary care physician in these centers.
- •Patients with a diagnosis of coronary heart disease, and / or transluminal angioplasty and / or coronary artery bypass grafting (CABG). These diagnoses must have occurred longer than six months from the time of inclusion.
- •Patients with a diagnosis of cerebrovascular accident (CVA), transient ischemic attack (TIA), carotid endarterectomy and / or carotid angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion.
- •Patients with peripheral arterial disease with or without intermittent claudication, revascularization surgery, bypass placement of arterial and / or peripheral arterial angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion.
- •Sedentary persons, defined as less than 90 minutes per week of moderate aerobic physical activity in their daily life (leisure, travel or work).
排除标准
- •Patients on chronic home monitoring and / or institutionalized before admission or living in a tertiary institution.
- •Moderate or severe limitation on functional capacity and / or mobility. or
- •Patients with dementia. or
- •Patients diagnosed with psychiatric illnesses that compromise patient autonomy. or
- •Life expectancy less than 1 year. or
- •Patients who do not want to take part in the program. or
- •Patients who are participating in another research protocol at recruitment. or
- •Patients with a diagnosis of intracranial hemorrhage secondary to aneurysmal rupture.
研究组 & 干预措施
Cognitive Behavioral Therapy
Participants in this arm will be invited to attend 8 weekly group meetings and 3 monthly follow-up meetings. In each meeting a coordinator will explore the experiences of the participants and encourage them to look for strategies to solve problems associated with changing habits. In the meetings we will use a therapeutic education approach with motivational interviewing techniques and problem solving in order to increase self-efficacy and motivation to adopt healthy habits. There will be periodic reminders and telephone contacts with patients before the meetings to assess the achievement of objectives.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Informational Workshop
Participants will be invited to participate in 4 weekly group meetings and an additional reinforcing meeting in the 5th month. In each meeting, workshop techniques will be used, together with educational materials as brochures, pictures, etc. The informational material will focus on the benefits of lifestyle changes in diet and physical activity.
干预措施: Informational Workshop (Behavioral)
结局指标
主要结局
Consumption of fruits and vegetables
时间窗: One year
Consumption of fruits and vegetables: number of servings per day measured by questionnaire WHO STEP wise (minimum 0; optimal 5 or more).
Achievement of moderate physical activity recommendations
时间窗: One year
Moderate physical activity: minutes per week measured by the questionnaire WHO STEP wise (Physical activity at work/in the household, for transport and during leisure time; minimum 0; the grater the better).
次要结局
- Smoking cessation(One year)
- Blood pressure control(One year)
- Body weight reduction(One year)
- Lipid Control(One year)
研究者
Gaston Perman
Head of Medical Programs
Hospital Italiano de Buenos Aires