Food Habits, Health Behavior, Motor Activity
Conditions
Keywords
Cognitive Therapy, Health Education, Secondary Prevention, Cardiovascular Disease
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).
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALInformational 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.
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence | 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. |
| Improvement in health related quality of Life | 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). |
Countries
Argentina
Outcome results
None listed