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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Behavioral: Individual counselling on lifestyles; Behavioral: Additional group counselling on lifestyles

• Registration Number: NCT03164499
• Lead Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Study Start: 2017-06-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Individual counselling on lifestyles	Individual counselling on lifestyles and additional group counselling on lifestyles.
Control group	Individual counselling on lifestyles	Individual counselling on lifestyles.
Intervention group	Additional group counselling on lifestyles	Individual counselling on lifestyles and additional group counselling on lifestyles.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Primary Care Research Unit, The Alamedilla Health Center; 🇪🇸 Salamanca, Castilla And Leon, Spain