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NCT03164499

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

Completed NA Last updated 16 April 2019
What this trial tests

NA trial testing Individual counselling on lifestyles in Cardiovascular Risk Factor in 203 participants. Completed in 31 March 2019.

Timeline
1 June 2017
Primary endpoint
31 December 2018
31 March 2019

Quick facts

Lead sponsorFundacion para la Investigacion y Formacion en Ciencias de la Salud
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment203
Start date1 June 2017
Primary completion31 December 2018
Estimated completion31 March 2019
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Who can join

Adults 35 to 74, any sex, with Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Strategies to improve smoking cessation rates in primary care.
    Lindson N, Pritchard G, Hong B, Fanshawe TR, et al · · 2021 · cited 45× · PMID 34693994 · DOI 10.1002/14651858.cd011556.pub2

Verify or expand the search:

Other recruiting trials for Cardiovascular Risk Factor

Currently open trials in the same condition.

Other Fundacion para la Investigacion y Formacion en Ciencias de la Salud trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing