Cardiovascular DiseasesNCT06071351
Motivational Interviewing Effect on Reducing Cardiovascular Disease Risk Factors
A study testing motivational interviewing based training program and Routine practice in people with Cardiovascular Diseases and Motivation, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to examine the effect of motivational interviewing-based training program on reducing cardiovascular disease risk factors in adults. Methods: In the first stage, individuals' CVD risk levels were determined. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Motivation, Nurse's Role
- What is being tested?
- motivational interviewing based training program and Routine practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 21 Mar 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being aged between 40 and 70 years,
- Being voluntary to participate in the study,
Who cannot join
- Having a known and diagnosed CVD
- Not being voluntary to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivational Interviewing Based Training Program in Adults Effect on Reducing Cardiovascular Disease Risk Factors: A Randomized Controlled Trial
Aim: The aim of this study is to examine the effect of motivational interviewing-based training program on reducing cardiovascular disease risk factors in adults.
Methods: In the first stage, individuals' CVD risk levels were determined. In the second stage, a 6-session motivational interview-based training program was applied to the intervention group with a medium CVD risk level (HearthSCORE score between 2 and 5 points). Brochures were distributed to the control group.
Read the detailed description
The aim of this study is to determine the CVD risks of adult individuals between the ages of 40-70 and to evaluate the effect of a motivational interview-based training program on reducing modifiable risk factors in individuals with moderate CVD risk.
Hypothesis; A 6-session motivational interview-based training program aimed at reducing CVD risk factors reduces the risk level in the intervention group more than the control group.
This study will be carried out in 2 stages. In the first phase, risk prevalence screening will be carried out to determine the CVD risks of individuals between October and November 2023. In the 2nd phase, a randomized controlled study will be conducted to evaluate the intervention program for individuals at medium risk level (HeartScore® between 2 and 5).
- Conditions
- Cardiovascular Diseases, Motivation, Nurse's Role, Risk Reduction
- Being tested
- motivational interviewing based training program, Routine practice
- Keywords
- cardiovascular disease, motivational interviewing, risk reduction, nurse's role
- Medical subject headings
- Cardiovascular Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewing based training programOther
In addition to the informative brochure prepared by the researcher; A 6-session training program based on motivational interviewing, including nutrition, physical activity, smoking and alcohol use, will be held.
Routine practiceOther
An informative brochure prepared by the researcher was given.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention group | Experimental | In addition to the informative brochure prepared by the researcher, a 6-session motivational interview-based training program will be given. The training program will include topics such as nutrition, physical activity, smoking and alcohol use. Receives: Other: motivational interviewing based training program |
| Control Group | Active comparator | An informative brochure prepared by the researcher and traditional consultancy services will be provided. Receives: Other: Routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
change is CVD risk level
In the first phase of the research, the "HeartScore®" program will be used to determine the CVD risk levels of individuals. Thanks to this program, the CVD risk levels of individuals will be learned and primary protection will be provided. According to "HeartScore®", CVD risk is discussed in 4 categories.
- 10%, very high risk,
- 5% - <10%, high risk, Medium risk between ≥2-<5%, If <1%, they are in the low risk category. As the score increases, the CVD risk level increases.
Measured: 24 week
Secondary outcomes (1)
Change in Physical Activity Level
Physical activity level was measured using the International Physical Activity Questionnaire Short Form (IPAQ).
Sitting 1.5 MET Walking 3.3 MET Moderate Intensity Physical Activity 4.0 MET Vigorous Physical Activity 8.0 MET Short form (7 questions); It provides information on time spent awake, moderate to vigorous intensity activities, and time spent sitting. The IPAQ categorically classifies individuals as "inactive," "minimally active," and "very active."
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Oct 2023
- Primary completion20 Mar 2024 (estimated)
- Study completion21 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan EVCİMEN, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071351
- Sponsor's protocol ID
- 07/07/2023- 7/51
- Status last verified
- Dec 2023
- First submitted
- 25 Sep 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing Based Training Program in Adults Effect on Reducing Cardiovascular Disease Risk Factors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06071351
- Acronym / sponsor ID
- 07/07/2023- 7/51
- Conditions
- Cardiovascular Diseases, Motivation, Nurse's Role, Risk Reduction
- Keywords
- cardiovascular disease, motivational interviewing, risk reduction, nurse's role
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 21 Mar 2024 (estimated)
- First posted
- 6 Oct 2023 (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.
Aim: The aim of this study is to examine the effect of motivational interviewing-based training program on reducing cardiovascular disease risk factors in adults.
Methods: In the first stage, individuals' CVD risk levels were determined. In the second stage, a 6-session motivational interview-based training program was applied to the intervention group with a medium CVD risk level (HearthSCORE score between 2 and 5 points). Brochures were distributed to the control group.
Detailed description
The aim of this study is to determine the CVD risks of adult individuals between the ages of 40-70 and to evaluate the effect of a motivational interview-based training program on reducing modifiable risk factors in individuals with moderate CVD risk.
Hypothesis; A 6-session motivational interview-based training program aimed at reducing CVD risk factors reduces the risk level in the intervention group more than the control group.
This study will be carried out in 2 stages. In the first phase, risk prevalence screening will be carried out to determine the CVD risks of individuals between October and November 2023. In the 2nd phase, a randomized controlled study will be conducted to evaluate the intervention program for individuals at medium risk level (HeartScore® between 2 and 5).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention group | Experimental | Other: motivational interviewing based training programIn addition to the informative brochure prepared by the researcher, a 6-session motivational interview-based training program will be given. The training program will include topics such as nutrition, physical activity, smoking and alcohol use. |
| Control Group | Active comparator | Other: Routine practiceAn informative brochure prepared by the researcher and traditional consultancy services will be provided. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being aged between 40 and 70 years,
- Being voluntary to participate in the study,
Key exclusion criteria (2 listed)
- Having a known and diagnosed CVD
- Not being voluntary to participate in the study.
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 |
|---|---|---|
| motivational interviewing based training programIn addition to the informative brochure prepared by the researcher; A 6-session training program based on motivational interviewing, including nutrition, physical activity, smoking and alcohol use, will be held. | Other | Experimental intervention group |
| Routine practiceAn informative brochure prepared by the researcher was given. | Other | Control Group |
Primary outcome
change is CVD risk level
Time frame: 24 week
In the first phase of the research, the "HeartScore®" program will be used to determine the CVD risk levels of individuals. Thanks to this program, the CVD risk levels of individuals will be learned and primary protection will be provided. According to "HeartScore®", CVD risk is discussed in 4 categories. * 10%, very high risk, * 5% - <10%, high risk, Medium risk between ≥2-<5%, If <1%, they are in the low risk category. As the score increases, the CVD risk level increases.
1 secondary outcome
Change in Physical Activity Level
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motivational interviewing based training program and Routine practice in people with Cardiovascular Diseases and Motivation, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 2 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 5 Dec 2023. 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 Turkey (Türkiye). 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?
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?
change is CVD risk level (time frame: 24 week). 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 5 Dec 2023.