Cardiovascular Risk Factors And Intensive Dietary Counselling

Andalusian Regional Ministry of Health

Status: Unknown

Conditions: High Blood Pressure; Hypercholesterolemia; Tobacco Smoking

Treatments: Behavioral: Individual-level Intensive Dietary Counselling; Behavioral: Group-level Intensive dietary Counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT02173600

PI-0969-12

Details and patient eligibility

About

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.

Enrollment: 630 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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630 participants in 2 patient groups

Group-level Intensive Dietary Counselling

Experimental group

Description:

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

Treatment:

Behavioral: Group-level Intensive dietary Counselling

Individual-level Intensive Dietary Counselling

Active Comparator group

Description:

Individualised dietary counselling delivered at the health-care point

Treatment:

Behavioral: Individual-level Intensive Dietary Counselling