High Blood PressureNCT02173600
Cardiovascular Risk Factors And Intensive Dietary Counselling
A study testing Group-level Intensive dietary Counselling and Individual-level Intensive Dietary Counselling in people with High Blood Pressure and Hypercholesterolemia, run by Andalusian Regional Ministry of Health.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure, Hypercholesterolemia, Tobacco Smoking
- What is being tested?
- Group-level Intensive dietary Counselling and Individual-level Intensive Dietary Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 40-65 years
- Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)
Who cannot join
- Currently diagnosed with any vardiovascular disease
- Currently involved in any other clinical trial
- Cognitive impairment that prevents from providing an informed consent
About this study
Official title: 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.
- Conditions
- High Blood Pressure, Hypercholesterolemia, Tobacco Smoking
- Being tested
- Group-level Intensive dietary Counselling, Individual-level Intensive Dietary Counselling
- Keywords
- Cardiovascular risk, Primary prevention, Intensive dietary counselling, Physical exercise
- Medical subject headings
- Hypertension, Hypercholesterolemia, Tobacco Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-level Intensive dietary CounsellingBehavioural
Individual-level Intensive Dietary CounsellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group-level Intensive Dietary Counselling | Experimental | Active learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time. Receives: Behavioral: Group-level Intensive dietary Counselling |
| Individual-level Intensive Dietary Counselling | Active comparator | Individualised dietary counselling delivered at the health-care point Receives: Behavioral: Individual-level Intensive Dietary Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.
Measured: upt to 12 months from the beginning
Secondary outcomes (1)
Health-Related Quality of Life
Spanish version of the EQ-5D-5L questionnaire by the EuroQol Group
Measured: Baseline, 6 and 12 months from the beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andalusian Regional Ministry of Health
- Sponsor type
- Other government
- Collaborators
- Andaluz Health Service
- Responsible party
- Principal investigator, Dr. María Ángeles Rubín-Gómez, Andalusian Regional Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173600
- Sponsor's protocol ID
- PI-0969-12
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Cardiovascular Risk After Intensive Dietary Counselling in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT02173600
- Acronym / sponsor ID
- PI-0969-12
- Conditions
- High Blood Pressure, Hypercholesterolemia, Tobacco Smoking
- Keywords
- Cardiovascular risk, Primary prevention, Intensive dietary counselling, Physical exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- Andalusian Regional Ministry of HealthOther government
- Collaborators
- Andaluz Health Service
- Study start
- May 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-level Intensive Dietary Counselling | Experimental | Behavioral: Group-level Intensive dietary CounsellingActive learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time. |
| Individual-level Intensive Dietary Counselling | Active comparator | Behavioral: Individual-level Intensive Dietary CounsellingIndividualised dietary counselling delivered at the health-care point |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 40-65 years
- Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)
Key exclusion criteria (3 listed)
- Currently diagnosed with any vardiovascular disease
- Currently involved in any other clinical trial
- Cognitive impairment that prevents from providing an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-level Intensive dietary Counselling | Behavioural | Group-level Intensive Dietary Counselling |
| Individual-level Intensive Dietary Counselling | Behavioural | Individual-level Intensive Dietary Counselling |
Primary outcome
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
1 secondary outcome
Health-Related Quality of Life
Time frame: Baseline, 6 and 12 months from the beginning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Group-level Intensive dietary Counselling and Individual-level Intensive Dietary Counselling in people with High Blood Pressure and Hypercholesterolemia, run by Andalusian Regional Ministry of Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.