Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
NCT ID: NCT03164499
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
203 participants
INTERVENTIONAL
2017-06-01
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control group
Individual counselling on lifestyles.
Individual counselling on lifestyles
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Intervention group
Individual counselling on lifestyles and additional group counselling on lifestyles.
Individual counselling on lifestyles
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Additional 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.
Interventions
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Individual counselling on lifestyles
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Additional 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unable to do exercise or follow the Mediterranean diet.
* Institutionalized.
* Terminal illness.
* Mental disorders that limited the intervention compliance.
35 Years
74 Years
ALL
No
Sponsors
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Instituto de Investigación Biomédica de Salamanca
OTHER
Fundacion para la Investigacion y Formacion en Ciencias de la Salud
OTHER
Responsible Party
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Principal Investigators
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Sara Mora Simón, PhD
Role: PRINCIPAL_INVESTIGATOR
Primary Care Research Unit, The Alamedilla Health Center
Locations
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Primary Care Research Unit, The Alamedilla Health Center
Salamanca, Castilla and Leon, Spain
Countries
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Other Identifiers
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BIO 16/00006
Identifier Type: -
Identifier Source: org_study_id
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