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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164499
• Other study ID #: BIO 16/00006
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Primary Care Research Unit, The Alamedilla Health Center	Salamanca	Castilla And Leon

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the Mediterranean diet	Measurement by validated 14-point Mediterranean Diet Adherence Screener	1 year
Primary	Self-reported physical activity	Measurement by short version of the International Physical Activity Questionnaire	1 year
Secondary	Changes in physical activity	Measurement by Pedometer	1 year
Secondary	Changes in dietary pattern	Measurement by semi-quantitative Food Frequency Questionnaire	1 year
Secondary	Cardiovascular risk factors	Measurement by Framingham Risk Score	1 year
Secondary	Body composition	Measurement by Bioelectrical Impedance Analyzer	1 year
Secondary	Cardio-ankle vascular index (CAVI)	Measurement by Vasera® VS-2000 device	1 year
Secondary	Brachial-ankle pulse wave velocity (ba-PWV)	Measurement by Vasera® VS-2000 device	1 year
Secondary	Ankle-brachial index (ABI)	Measurement by Vasera® VS-2000 device	1 year
Secondary	Health related quality of life	Measurement by Spanish version of the SF-12 questionnaire	1 year
Secondary	Immediate verbal memory	Assessment by immediate recall of a list of 15 words, in three attempts	1 year
Secondary	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
Secondary	Phonological fluency	Assessment by enumerating for one minute as many words as possible starting with different letters	1 year
Secondary	Attention	Assessment by Trail Making Test A	1 year
Secondary	Processing speed	Assessment by Trail Making Test B	1 year
Secondary	Executive functions	Assessment by Trail Making Test B	1 year
Secondary	Working memory	Assessment by WAIS Digit Span Backward test	1 year
Secondary	Sustained attention	Assessment by Stroop test	1 year
Secondary	Selective attention	Assessment by Stroop test	1 year