Cardiovascular Risk Factors And Intensive Dietary Counselling

Estimation of Cardiovascular Risk After Intensive Dietary Counselling in a Primary Care Setting

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02173600

Enrollment

630

Registered

2014-06-25

Start date

2014-05-31

Completion date

2015-12-31

Last updated

2014-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Pressure, Hypercholesterolemia, Tobacco Smoking

Keywords

Cardiovascular risk, Primary prevention, Intensive dietary counselling, Physical exercise

Brief summary

The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion activity. It is being implemented by the Andalusian Health Service to reinforce basic intervention advice on healthy diet and exercise. The IDC intervention is aimed at the prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and stroke). The main objective of the present study is to assess adherence to the IDC intervention and, consequently, its effectiveness on the prevention of the above mentioned diseases.

Interventions

BEHAVIORALGroup-level Intensive dietary Counselling

BEHAVIORALIndividual-level Intensive Dietary Counselling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Age between 40-65 years * Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)

Exclusion criteria

* Currently diagnosed with any vardiovascular disease * Currently involved in any other clinical trial * Cognitive impairment that prevents from providing an informed consent

Design outcomes

Primary

Measure	Time frame
Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.	upt to 12 months from the beginning

Secondary

Measure	Time frame	Description
Health-Related Quality of Life	Baseline, 6 and 12 months from the beginning	Spanish version of the EQ-5D-5L questionnaire by the EuroQol Group

Other

Measure	Time frame	Description
Chronic low-grade inflammation	Baseline, 6 and 12 months from the beginning	High sensibility c-reactive protein

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026