Cardiovascular Risk Factors And Intensive Dietary Counselling

Not Applicable

• Conditions: High Blood Pressure; Hypercholesterolemia; Tobacco Smoking
• Interventions: Behavioral: Group-level Intensive dietary Counselling; Behavioral: Individual-level Intensive Dietary Counselling

• Registration Number: NCT02173600
• Lead Sponsor: Andalusian Regional Ministry of Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Study First Posted: 2014-06-25
• Last Update Posted: 2014-06-25
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 630

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-level Intensive Dietary Counselling	Group-level Intensive dietary Counselling	Active learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time.
Individual-level Intensive Dietary Counselling	Individual-level Intensive Dietary Counselling	Individualised dietary counselling delivered at the health-care point

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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