Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Health Behavior, Motor Activity, Food Habits

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Informational Workshop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. or 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. or 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. or 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. and Sedentary persons, defined as less than 90 minutes per week of moderate aerobic physical activity in their daily life (leisure, travel or work). Exclusion Criteria: - Patients on chronic home monitoring and / or institutionalized before admission or living in a tertiary institution. or 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>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. | Behavioral: Cognitive Behavioral Therapy<br>* 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.<br>|
| Active Comparator: Informational Workshop<br>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. | Behavioral: Informational Workshop<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Moderate physical activity: minutes per week measured by the questionnaire WHO STEP wise. | One year | 
| Consumption of fruits and vegetables | Consumption of fruits and vegetables: number of servings per day measured by questionnaire WHO STEP wise. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation | Smoking cessation: will be considered if patients report smoking abstinence (no smoking consumption for the last three months), at the end of the study. | One year | 
| Blood pressure control | Blood pressure will be considered controlled if systolic blood pressure values are lower than 140 mmHg and/or if there is a decrease in at least 5% from basal at the end of the program. | One year | 
| Lipid Control | LDL cholesterol will be considered controlled if the patient has LDL values below 100 mg/dl or a reduction of at least 20% from basal at the end of the program. | One year | 
| Body weight reduction | Reducing at least 5% from basal of body weight at endpoint in those patients with a body mass index (BMI) in a value greater than 30 kg/m2 at baseline. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Therapy, Health Education, Secondary Prevention, Cardiovascular Disease