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.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Individual counselling on lifestyles; Behavioral: Additional group counselling on lifestyles

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castilla And Leon
    • Salamanca, Castilla And Leon, Spain, 37003
      • Primary Care Research Unit, The Alamedilla Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Individual counselling on lifestyles.	Behavioral: Individual counselling on lifestyles; Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Experimental: Intervention group; Individual counselling on lifestyles and additional group counselling on lifestyles.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the Mediterranean diet	Measurement by validated 14-point Mediterranean Diet Adherence Screener	1 year
Self-reported physical activity	Measurement by short version of the International Physical Activity Questionnaire	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Collaborators: Instituto de Investigación Biomédica de Salamanca
• Investigators: Principal Investigator: Sara Mora Simón, PhD, Primary Care Research Unit, The Alamedilla Health Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 22, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Quality of life; Risk factors; Cardiovascular diseases; Cognitive performance; Health education; Life style
• Other Study ID Numbers: BIO 16/00006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No