Cardiovascular Risk Factors And Intensive Dietary Counselling
Estimation of Cardiovascular Risk After Intensive Dietary Counselling in a Primary Care Setting
1 other identifier
interventional
630
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 25, 2014
June 1, 2014
1.1 years
June 24, 2014
June 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Health-Related Quality of Life
Baseline, 6 and 12 months from the beginning
Other Outcomes (1)
Chronic low-grade inflammation
Baseline, 6 and 12 months from the beginning
Study Arms (2)
Group-level Intensive Dietary Counselling
EXPERIMENTALActive learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time.
Individual-level Intensive Dietary Counselling
ACTIVE COMPARATORIndividualised dietary counselling delivered at the health-care point
Interventions
Eligibility Criteria
You may qualify if:
- Age between 40-65 years
- Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)
You may not qualify if:
- Currently diagnosed with any vardiovascular disease
- Currently involved in any other clinical trial
- Cognitive impairment that prevents from providing an informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andalusian Regional Ministry of Healthlead
- Andaluz Health Servicecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 24, 2014
First Posted
June 25, 2014
Study Start
May 1, 2014
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
June 25, 2014
Record last verified: 2014-06