Estimation of Cardiovascular Risk After Intensive Dietary Counselling in a Primary Care Setting
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 630
- Primary Endpoint
- Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.
Time Frame: upt to 12 months from the beginning
Secondary Outcomes
- Health-Related Quality of Life(Baseline, 6 and 12 months from the beginning)
Investigators
Dr. María Ángeles Rubín-Gómez
Dr
Andalusian Regional Ministry of Health