Cardiovascular Risk FactorNCT03164499
Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
A study testing Individual counselling on lifestyles and Additional group counselling on lifestyles in people with Cardiovascular Risk Factor, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
This is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness. 200 participants aged 35-74 years who have intermediate cardiovascular risk will be included. Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Individual counselling on lifestyles and Additional group counselling on lifestyles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 31 Mar 2019
- 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 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.
Who cannot join
- Personal history of atherosclerotic disease.
- Unable to do exercise or follow the Mediterranean diet.
- Institutionalized.
- Terminal illness.
- Mental disorders that limited the intervention compliance.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Care Research Unit, The Alamedilla Health Center
Salamanca, Castilla and Leon, 37003
About this study
Official title: Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.
This is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness. 200 participants aged 35-74 years who have intermediate cardiovascular risk will be included. Subjects will be selected by consecutive sampling at urban primary care health centers from Salamanca (Spain) and they will be randomized to a control or an intervention group. Both groups will receive individual standardized counselling on healthy diet, daily physical activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals from the intervention group will receive additional group counselling and follow-up calls. The effect of the intervention will be assessed using lifestyles and quality of life questionnaires, metabolic control parameters, inflammation markers, anthropometric and vascular function measurements, and neuropsychological tests.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Individual counselling on lifestyles, Additional group counselling on lifestyles
- Keywords
- Health education, Life style, Risk factors, Cardiovascular diseases, Cognitive performance, Quality of life
- Medical subject headings
- Health Education, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual counselling on lifestylesBehavioural
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Additional group counselling on lifestylesBehavioural
Group sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed.
Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Individual counselling on lifestyles. Receives: Behavioral: Individual counselling on lifestyles |
| Intervention group | Experimental | Individual counselling on lifestyles and additional group counselling on lifestyles. Receives: Behavioral: Individual counselling on lifestyles; Behavioral: Additional group counselling on lifestyles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Mediterranean diet
Measurement by validated 14-point Mediterranean Diet Adherence Screener
Measured: 1 year
Self-reported physical activity
Measurement by short version of the International Physical Activity Questionnaire
Measured: 1 year
Secondary outcomes (17)
Changes in physical activity
Measurement by Pedometer
Measured: 1 year
Changes in dietary pattern
Measurement by semi-quantitative Food Frequency Questionnaire
Measured: 1 year
Cardiovascular risk factors
Measurement by Framingham Risk Score
Measured: 1 year
Body composition
Measurement by Bioelectrical Impedance Analyzer
Measured: 1 year
Cardio-ankle vascular index (CAVI)
Measurement by Vasera® VS-2000 device
Measured: 1 year
Brachial-ankle pulse wave velocity (ba-PWV)
Measurement by Vasera® VS-2000 device
Measured: 1 year
Ankle-brachial index (ABI)
Measurement by Vasera® VS-2000 device
Measured: 1 year
Health related quality of life
Measurement by Spanish version of the SF-12 questionnaire
Measured: 1 year
Immediate verbal memory
Assessment by immediate recall of a list of 15 words, in three attempts
Measured: 1 year
Delayed verbal memory
Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes
Measured: 1 year
Phonological fluency
Assessment by enumerating for one minute as many words as possible starting with different letters
Measured: 1 year
Attention
Assessment by Trail Making Test A
Measured: 1 year
Processing speed
Assessment by Trail Making Test B
Measured: 1 year
Executive functions
Assessment by Trail Making Test B
Measured: 1 year
Working memory
Assessment by WAIS Digit Span Backward test
Measured: 1 year
Sustained attention
Assessment by Stroop test
Measured: 1 year
Selective attention
Assessment by Stroop test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Responsible party
- Sponsor
- Investigators
- Sara Mora Simón, PhD, Principal investigator, Primary Care Research Unit, The Alamedilla Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164499
- Sponsor's protocol ID
- BIO 16/00006
- Status last verified
- Apr 2019
- First submitted
- 22 May 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03164499
- Acronym / sponsor ID
- BIO 16/00006
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Health education, Life style, Risk factors, Cardiovascular diseases, Cognitive performance, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 23 May 2017 (actual)
- 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.
This is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness. 200 participants aged 35-74 years who have intermediate cardiovascular risk will be included. Subjects will be selected by consecutive sampling at urban primary care health centers from Salamanca (Spain) and they will be randomized to a control or an intervention group. Both groups will receive individual standardized counselling on healthy diet, daily physical activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals from the intervention group will receive additional group counselling and follow-up calls. The effect of the intervention will be assessed using lifestyles and quality of life questionnaires, metabolic control parameters, inflammation markers, anthropometric and vascular function measurements, and neuropsychological tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Individual counselling on lifestylesIndividual counselling on lifestyles. |
| Intervention group | Experimental | Behavioral: Individual counselling on lifestyles, Behavioral: Additional group counselling on lifestylesIndividual counselling on lifestyles and additional group counselling on lifestyles. |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.
Key exclusion criteria (5 listed)
- Personal history of atherosclerotic disease.
- Unable to do exercise or follow the Mediterranean diet.
- Institutionalized.
- Terminal illness.
- Mental disorders that limited the intervention compliance.
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 |
|---|---|---|
| Individual counselling on lifestylesIndividual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption. | Behavioural | Control group, Intervention group |
| Additional group counselling on lifestylesGroup sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed. Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment. | Behavioural | Intervention group |
Primary outcome
Adherence to the Mediterranean diet
Time frame: 1 year
Measurement by validated 14-point Mediterranean Diet Adherence Screener
Self-reported physical activity
Time frame: 1 year
Measurement by short version of the International Physical Activity Questionnaire
17 secondary outcomes
Changes in physical activity
Time frame: 1 year
Changes in dietary pattern
Time frame: 1 year
Cardiovascular risk factors
Time frame: 1 year
Body composition
Time frame: 1 year
Cardio-ankle vascular index (CAVI)
Time frame: 1 year
Brachial-ankle pulse wave velocity (ba-PWV)
Time frame: 1 year
Ankle-brachial index (ABI)
Time frame: 1 year
Health related quality of life
Time frame: 1 year
Immediate verbal memory
Time frame: 1 year
Delayed verbal memory
Time frame: 1 year
Phonological fluency
Time frame: 1 year
Attention
Time frame: 1 year
Processing speed
Time frame: 1 year
Executive functions
Time frame: 1 year
Working memory
Time frame: 1 year
Sustained attention
Time frame: 1 year
Selective attention
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Sara Mora Simón, PhD principal investigator
Primary Care Research Unit, The Alamedilla Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual counselling on lifestyles and Additional group counselling on lifestyles in people with Cardiovascular Risk Factor, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to the Mediterranean diet (time frame: 1 year). The study lists 2 primary outcomes in all. 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 16 Apr 2019.