NCT03164499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

May 22, 2017

Last Update Submit

April 12, 2019

Conditions

Cardiovascular Risk Factor

Keywords

Health educationLife styleRisk factorsCardiovascular diseasesCognitive performanceQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (17)

  • Changes in physical activity

    1 year

  • Changes in dietary pattern

    1 year

  • Cardiovascular risk factors

    1 year

  • Body composition

    1 year

  • Cardio-ankle vascular index (CAVI)

    1 year

  • +12 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Individual counselling on lifestyles.

Behavioral: Individual counselling on lifestyles

Intervention group

EXPERIMENTAL

Individual counselling on lifestyles and additional group counselling on lifestyles.

Behavioral: Individual counselling on lifestylesBehavioral: Additional group counselling on lifestyles

Interventions

Individual counselling on lifestylesBEHAVIORAL

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

Control groupIntervention group
Additional group counselling on lifestylesBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.

You may not qualify if:

  • Personal history of atherosclerotic disease.
  • Unable to do exercise or follow the Mediterranean diet.
  • Institutionalized.
  • Terminal illness.
  • Mental disorders that limited the intervention compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Research Unit, The Alamedilla Health Center

Salamanca, Castilla and Leon, 37003, Spain

Location

MeSH Terms

Conditions

Health EducationCardiovascular Diseases

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sara Mora Simón, PhD

    Primary Care Research Unit, The Alamedilla Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 23, 2017

Study Start

June 1, 2017

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

ES(1)