Last reviewed · How we verify
NCT03164499
Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
NA trial testing Individual counselling on lifestyles in Cardiovascular Risk Factor in 203 participants. Completed in 31 March 2019.
31 December 2018
Quick facts
| Lead sponsor | Fundacion para la Investigacion y Formacion en Ciencias de la Salud |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 203 |
| Start date | 1 June 2017 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 March 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Individual counselling on lifestyles
- Additional group counselling on lifestyles
Conditions studied
- Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
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):
-
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:
- PubMed search for NCT03164499
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03164499 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Last refreshed: 16 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03164499.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing