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Completed

NCT Number: NCT01861977

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

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).

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

Behavioral

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 outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Smoking cessation

    Time frame: 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.

  2. Blood pressure control

    Time frame: 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.

  3. Lipid Control

    Time frame: 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.

  4. Body weight reduction

    Time frame: 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.

Other outcomes

  1. Improvement in health related quality of Life

    Time frame: One year.

    Perception of quality of life will be assessed through EuroQol questionnaire (validated in Spanish). It will analyze the difference (final-basal) between the two groups. The visual analog scale ranges from 0 (worse quality of life possible) to 100 (best possible state).

  2. Treatment Adherence

    Time frame: One year

    Maintaining adherence to prescribed drug treatments: adherence to drug treatment will be evaluated through Medication Adherence Questionnaire. It will analyze the final difference (final-basal) between the two groups.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 24, 2013
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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