Cardiovascular Risk Factors And Intensive Dietary Counselling

NCT ID: NCT02173600

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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High Blood Pressure Hypercholesterolemia Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group-level Intensive Dietary Counselling

Active learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time.

Group Type EXPERIMENTAL

Group-level Intensive dietary Counselling

Intervention Type BEHAVIORAL

Individual-level Intensive Dietary Counselling

Individualised dietary counselling delivered at the health-care point

Group Type ACTIVE_COMPARATOR

Individual-level Intensive Dietary Counselling

Intervention Type BEHAVIORAL

Interventions

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Group-level Intensive dietary Counselling

Intervention Type BEHAVIORAL

Individual-level Intensive Dietary Counselling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Andaluz Health Service

OTHER_GOV

Sponsor Role collaborator

Andalusian Regional Ministry of Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. María Ángeles Rubín-Gómez

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PI-0969-12

Identifier Type: -

Identifier Source: org_study_id

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