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

Not Applicable

Completed

• Conditions: Health Behavior; Food Habits; Motor Activity
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Informational Workshop

• Registration Number: NCT01861977
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Study Start: 2013-06
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	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.
Informational Workshop	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.

Primary Outcome Measures

Name	Time	Method
Consumption of fruits and vegetables	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	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).

Secondary Outcome Measures

Name	Time	Method
Smoking cessation	One year	Smoking cessation: will be considered if patients report smoking abstinence (no smoking consumption for the last three months), at the end of the study.
Blood pressure control	One year	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.
Body weight reduction	One year	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.
Lipid Control	One year	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.

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autónoma de Buenos Aires, Caba, Argentina