This is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness. 200 participants aged 35-74 years who have intermediate cardiovascular risk will be included. Subjects will be selected by consecutive sampling at urban primary care health centers from Salamanca (Spain) and they will be randomized to a control or an intervention group. Both groups will receive individual standardized counselling on healthy diet, daily physical activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals from the intervention group will receive additional group counselling and follow-up calls. The effect of the intervention will be assessed using lifestyles and quality of life questionnaires, metabolic control parameters, inflammation markers, anthropometric and vascular function measurements, and neuropsychological tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
203
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Group sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed. Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment.
Primary Care Research Unit, The Alamedilla Health Center
Salamanca, Castilla and Leon, Spain
Adherence to the Mediterranean diet
Measurement by validated 14-point Mediterranean Diet Adherence Screener
Time frame: 1 year
Self-reported physical activity
Measurement by short version of the International Physical Activity Questionnaire
Time frame: 1 year
Changes in physical activity
Measurement by Pedometer
Time frame: 1 year
Changes in dietary pattern
Measurement by semi-quantitative Food Frequency Questionnaire
Time frame: 1 year
Cardiovascular risk factors
Measurement by Framingham Risk Score
Time frame: 1 year
Body composition
Measurement by Bioelectrical Impedance Analyzer
Time frame: 1 year
Cardio-ankle vascular index (CAVI)
Measurement by Vasera® VS-2000 device
Time frame: 1 year
Brachial-ankle pulse wave velocity (ba-PWV)
Measurement by Vasera® VS-2000 device
Time frame: 1 year
Ankle-brachial index (ABI)
Measurement by Vasera® VS-2000 device
Time frame: 1 year
Health related quality of life
Measurement by Spanish version of the SF-12 questionnaire
Time frame: 1 year
Immediate verbal memory
Assessment by immediate recall of a list of 15 words, in three attempts
Time frame: 1 year
Delayed verbal memory
Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes
Time frame: 1 year
Phonological fluency
Assessment by enumerating for one minute as many words as possible starting with different letters
Time frame: 1 year
Attention
Assessment by Trail Making Test A
Time frame: 1 year
Processing speed
Assessment by Trail Making Test B
Time frame: 1 year
Executive functions
Assessment by Trail Making Test B
Time frame: 1 year
Working memory
Assessment by WAIS Digit Span Backward test
Time frame: 1 year
Sustained attention
Assessment by Stroop test
Time frame: 1 year
Selective attention
Assessment by Stroop test
Time frame: 1 year
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