Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Individual counselling on lifestyles
* Behavioral: Additional group counselling on lifestyles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Individual counselling on lifestyles. | Behavioral: Individual counselling on lifestyles<br>* Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.<br>|
| Experimental: Intervention group<br>Individual counselling on lifestyles and additional group counselling on lifestyles. | Behavioral: Individual counselling on lifestyles<br>* Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.<br>Behavioral: Additional group counselling on lifestyles<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Mediterranean diet | Measurement by validated 14-point Mediterranean Diet Adherence Screener | 1 year | 
| Self-reported physical activity | Measurement by short version of the International Physical Activity Questionnaire | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in physical activity | Measurement by Pedometer | 1 year | 
| Changes in dietary pattern | Measurement by semi-quantitative Food Frequency Questionnaire | 1 year | 
| Cardiovascular risk factors | Measurement by Framingham Risk Score | 1 year | 
| Body composition | Measurement by Bioelectrical Impedance Analyzer | 1 year | 
| Cardio-ankle vascular index (CAVI) | Measurement by Vasera® VS-2000 device | 1 year | 
| Brachial-ankle pulse wave velocity (ba-PWV) | Measurement by Vasera® VS-2000 device | 1 year | 
| Ankle-brachial index (ABI) | Measurement by Vasera® VS-2000 device | 1 year | 
| Health related quality of life | Measurement by Spanish version of the SF-12 questionnaire | 1 year | 
| Immediate verbal memory | Assessment by immediate recall of a list of 15 words, in three attempts | 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 | 1 year | 
| Phonological fluency | Assessment by enumerating for one minute as many words as possible starting with different letters | 1 year | 
| Attention | Assessment by Trail Making Test A | 1 year | 
| Processing speed | Assessment by Trail Making Test B | 1 year | 
| Executive functions | Assessment by Trail Making Test B | 1 year | 
| Working memory | Assessment by WAIS Digit Span Backward test | 1 year | 
| Sustained attention | Assessment by Stroop test | 1 year | 
| Selective attention | Assessment by Stroop test | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health education, Life style, Risk factors, Cardiovascular diseases, Cognitive performance, Quality of life