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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861977
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Gaston Perman, Hospital Italiano de Buenos Aires

Study Description
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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).

Condition or disease Intervention/treatment Phase
Health Behavior Motor Activity Food Habits Behavioral: Cognitive Behavioral Therapy Behavioral: Informational Workshop Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : June 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: 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.
Active Comparator: 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.
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Physical activity [ Time Frame: One year ]
    Moderate physical activity: minutes per week measured by the questionnaire WHO STEP wise.

  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.


Secondary Outcome Measures :
  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 Outcome Measures:
  1. 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.

  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861977


Locations
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Argentina
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Caba, Argentina
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Study Director: Gaston Perman, MD, MSc Hospital Italiano de Buenos Aires
Principal Investigator: Gabriela Buela, MD Hospital Italiano de Buenos Aires
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Gaston Perman, Head of Medical Programs, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01861977    
Other Study ID Numbers: 2009
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Keywords provided by Gaston Perman, Hospital Italiano de Buenos Aires:
Cognitive Therapy
Health Education
Secondary Prevention
Cardiovascular Disease
Additional relevant MeSH terms:
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Cardiovascular Diseases