Cardiovascular Risk Factors And Intensive Dietary Counselling

June 24, 2014 updated by: Dr. María Ángeles Rubín-Gómez, Andalusian Regional Ministry of Health

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

630

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group-level Intensive Dietary Counselling
Active learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time.
Behavioral: Group-level Intensive dietary Counselling
Active Comparator: Individual-level Intensive Dietary Counselling
Individualised dietary counselling delivered at the health-care point
Behavioral: Individual-level Intensive Dietary Counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
upt to 12 months from the beginning

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian Regional Ministry of Health

Collaborators

Andaluz Health Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-0969-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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