Cardiovascular Risk Factors And Intensive Dietary Counselling

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02173600
• Other study ID #: PI-0969-12
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 24, 2014
• Last updated: June 24, 2014
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Andalusian Regional Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 630
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• High Blood Pressure
• Hypercholesterolemia
• Hypertension
• Tobacco Smoking

Intervention

Behavioral:
• Group-level Intensive dietary Counselling

• Individual-level Intensive Dietary Counselling

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Andalusian Regional Ministry of Health	Andaluz Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic low-grade inflammation	High sensibility c-reactive protein	Baseline, 6 and 12 months from the beginning	No
Primary	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	No
Secondary	Health-Related Quality of Life	Spanish version of the EQ-5D-5L questionnaire by the EuroQol Group	Baseline, 6 and 12 months from the beginning	No