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

Hospital Italiano de Buenos Aires

Status: Completed

Conditions: Food Habits; Motor Activity; Health Behavior

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Informational Workshop

Study type: Interventional

Funder types: Other

Identifiers

NCT01861977

2009

Details and patient eligibility

About

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).

Enrollment: 101 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

Cognitive Behavioral Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy

Informational Workshop

Active Comparator group

Description:

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.

Treatment:

Behavioral: Informational Workshop