NCT03164499

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud · Academic / Other
• Sex: All
• Age: 35 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Risk Factor

Interventions

Type	Name	Description
BEHAVIORAL	Individual counselling on lifestyles	Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
BEHAVIORAL	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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-12-31
• Completion: 2019-03-31
• First posted: 2017-05-23
• Last updated: 2019-04-16

Locations

1 site across 1 country: Spain