Cardiovascular Risk Factor
Conditions
Keywords
Health education, Life style, Risk factors, Cardiovascular diseases, Cognitive performance, Quality of life
Brief summary
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.
Interventions
BEHAVIORALIndividual counselling on lifestyles
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
BEHAVIORALAdditional group counselling on lifestyles
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.
Sponsors
Instituto de Investigación Biomédica de Salamanca
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.
Exclusion criteria
* Personal history of atherosclerotic disease. * Unable to do exercise or follow the Mediterranean diet. * Institutionalized. * Terminal illness. * Mental disorders that limited the intervention compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Mediterranean diet | 1 year | Measurement by validated 14-point Mediterranean Diet Adherence Screener |
| Self-reported physical activity | 1 year | Measurement by short version of the International Physical Activity Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular risk factors | 1 year | Measurement by Framingham Risk Score |
| Body composition | 1 year | Measurement by Bioelectrical Impedance Analyzer |
| Cardio-ankle vascular index (CAVI) | 1 year | Measurement by Vasera® VS-2000 device |
| Brachial-ankle pulse wave velocity (ba-PWV) | 1 year | Measurement by Vasera® VS-2000 device |
| Ankle-brachial index (ABI) | 1 year | Measurement by Vasera® VS-2000 device |
| Health related quality of life | 1 year | Measurement by Spanish version of the SF-12 questionnaire |
| Immediate verbal memory | 1 year | Assessment by immediate recall of a list of 15 words, in three attempts |
| Changes in physical activity | 1 year | Measurement by Pedometer |
| Phonological fluency | 1 year | Assessment by enumerating for one minute as many words as possible starting with different letters |
| Attention | 1 year | Assessment by Trail Making Test A |
| Processing speed | 1 year | Assessment by Trail Making Test B |
| Executive functions | 1 year | Assessment by Trail Making Test B |
| Working memory | 1 year | Assessment by WAIS Digit Span Backward test |
| Sustained attention | 1 year | Assessment by Stroop test |
| Selective attention | 1 year | Assessment by Stroop test |
| Delayed verbal memory | 1 year | Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes |
| Changes in dietary pattern | 1 year | Measurement by semi-quantitative Food Frequency Questionnaire |
Countries
Spain
Outcome results
None listed