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Clinical Trials/NCT01861977
NCT01861977
Completed
Not Applicable

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.

Hospital Italiano de Buenos Aires1 site in 1 country101 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health Behavior
Sponsor
Hospital Italiano de Buenos Aires
Enrollment
101
Locations
1
Primary Endpoint
Consumption of fruits and vegetables
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gaston Perman

Head of Medical Programs

Hospital Italiano de Buenos Aires

Eligibility Criteria

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.
  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Consumption of fruits and vegetables

Time Frame: 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

Time Frame: 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 Outcomes

  • Smoking cessation(One year)
  • Blood pressure control(One year)
  • Body weight reduction(One year)
  • Lipid Control(One year)

Study Sites (1)

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