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

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Behavioral: Individual counselling on lifestyles; Behavioral: Additional group counselling on lifestyles

Study type: Interventional

Funder types: Other

Identifiers

NCT03164499

BIO 16/00006

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 35 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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203 participants in 2 patient groups

Control group

Active Comparator group

Description:

Individual counselling on lifestyles.

Treatment:

Behavioral: Individual counselling on lifestyles

Intervention group

Experimental group

Description:

Individual counselling on lifestyles and additional group counselling on lifestyles.

Treatment:

Behavioral: Individual counselling on lifestyles

Behavioral: Additional group counselling on lifestyles