Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., Argentina
NCT Number: NCT01861977
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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Notify Me45 year–80 year
All sexes
Interventional
Not applicable
Buenos Aires, Buenos Aires F.D., Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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Exclusion criteria
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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.
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.
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).
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).
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.
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.
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.
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.
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).
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.
Hospital Italiano de Buenos Aires
Other
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.
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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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