xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06000436</url>
    </required_header>
    <id_info>
      <org_study_id>NecmettinEU70</org_study_id>
      <nct_id>NCT06000436</nct_id>
    </id_info>
    <brief_title>Cardiovascular Disease Risk of Awareness</brief_title>
    <official_title>The Effect on Risk Awareness, Perception and Risk Factors of Motivational Interview-Based Cardiovascular Risk Reduction Program (CARDIOREP) in Taxi-Minibus Drivers: A Randomized Controlled Research</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Necmettin Erbakan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Necmettin Erbakan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce&#xD;
        risk factors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        While 1/3 of premature deaths in individuals under the age of 70 in the world occur due to&#xD;
        Cardiovascular Diseases (WHO 2022), circulatory system diseases are at the forefront with&#xD;
        36.76% according to the health statistics of the Ministry of Health in our country. It is&#xD;
        necessary to raise awareness and gain healthy lifestyle behaviors in the prevention of&#xD;
        cardiovascular diseases. The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise&#xD;
        risk awareness and reduce risk factors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cardiovascular Disease Risk Awareness Rating Scale Scores</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>The scale form consists of 3 sub-dimensions and 21 items. The sub-dimensions consist of perceived heart attack and stroke risk, healthy eating intentions, perceived benefits and intentions to change. A maximum score of 64 and a minimum score of 0 can be obtained from the scale. A higher score on the scale and its sub-dimensions indicates an increased awareness of cardiovascular diseases.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular risk perception</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>Perceived cardiovascular disease risk in the next 10 years is questioned as low, moderate, high and very high.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>International Physical Activity Questionnaire Scores</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>The international physical activity questionnaire (Short Form) consists of 7 questions. The questionnaire asks about the number of days of vigorous, moderate, mild physical activity in the last 7 days and how much of the day, and how much time is spent sitting in individuals who do not engage in physical activity. It provides the calculation of the energy expended by the activities in meters. A high score on the scale form indicates being active in physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Beck Anxiety Scale Scores</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>The scale form consists of 21 questions on a 4-point Likert scale (0=none, 3=seriously) about anxiety symptoms in the last one week.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular disease risk factors</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>anthropometric measurements weight (Kilograms)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular disease risk factors</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>anthropometric measurements height (meter)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular disease risk factors</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>anthropometric measurements hip circumference (centimeters)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular disease risk factors</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>anthropometric measurements waist circumference (centimeters)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiovascular disease risk factors</measure>
      <time_frame>at the end of 0th, 6th, and 12th weeks</time_frame>
      <description>blood pressure (mmHg)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <arm_group>
      <arm_group_label>Intervention/treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Health education, mobile applications, monitoring, Cardiovascular disease risk assessment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Cardiovascular disease risk assessment</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cardiovascular disease risk assessment</intervention_name>
      <description>Cardiovascular disease risk assessment&#xD;
  Training and Consultancy Based on the literature, the researcher prepared a Training Guide for the Prevention of Cardiovascular Diseases, including the subjects of Cardiovascular Diseases and Risk Factors, Physical Activity, Smoking and Heart Health, BMI and Heart Health, Nutrition, and Stress. By using the training guide, training time for individual training intervention will be planned for one day of the week with the participants. Individual training will last 30 minutes at the stops with waiting areas during the working hours of the participants.&#xD;
  Mobile Application To the participants in the intervention group 2, 4. In the 6th and 6th weeks, text messages will be shared once a week to increase motivation and prevent cardiovascular diseases.&#xD;
  Monitoring Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.</description>
      <arm_group_label>Active group</arm_group_label>
      <arm_group_label>Intervention/treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Training and Consultancy</intervention_name>
      <description>Based on the literature, the researcher prepared a Training Guide for the Prevention of Cardiovascular Diseases, including the subjects of Cardiovascular Diseases and Risk Factors, Physical Activity, Smoking and Heart Health, BMI and Heart Health, Nutrition, and Stress. Using the training guide, training time for individual training intervention will be planned for one day of the week with the participants. Individual training will last 30 minutes at the stops with waiting areas during the participants' working hours.</description>
      <arm_group_label>Intervention/treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mobile Application</intervention_name>
      <description>To the participants in the intervention group 2, 4. In the 6th and 6th weeks, text messages will be shared once a week to increase motivation and prevent cardiovascular diseases.&#xD;
  Text Messages Week 2 &quot;Tobacco use causes 6 million deaths in the world. The risk of death is reduced by 90% in those who stop using tobacco. Alcohol use causes damage to the heart muscle, arrhythmia, and stroke. For a healthy life, you should stay away from smoking and alcohol. ' Week 4 '' Inadequate physical activity increases the risk of death from all causes. Physical activity reduces the risk of hypertension, stroke, and depression. 30 minutes of moderate-intensity physical activity daily is recommended.&#xD;
  Week 6 &quot;Adequate consumption of vegetables and fruits reduces the risk of cardiovascular disease. Saturated and trans fats increase the risk of cardiovascular disease. It is recommended to consume &lt;5 g less per day to prevent cardiovascular diseases.</description>
      <arm_group_label>Intervention/treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Monitoring</intervention_name>
      <description>Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.</description>
      <arm_group_label>Active group</arm_group_label>
      <arm_group_label>Intervention/treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Not having been diagnosed with cardiovascular disease.&#xD;
  &#xD;
            -  Using a smartphone.&#xD;
  &#xD;
            -  Agree to use the Google Fit App.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
      <investigator_full_name>Serdar ulak</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06000436
  org study id: NecmettinEU70
  nct id: NCT06000436
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce
        risk factors.
  While 1/3 of premature deaths in individuals under the age of 70 in the world occur due to
        Cardiovascular Diseases (WHO 2022), circulatory system diseases are at the forefront with
        36.76% according to the health statistics of the Ministry of Health in our country. It is
        necessary to raise awareness and gain healthy lifestyle behaviors in the prevention of
        cardiovascular diseases. The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise
        risk awareness and reduce risk factors.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Cardiovascular Disease Risk Awareness Rating Scale Scores
  time frame: at the end of 0th, 6th, and 12th weeks
  description: The scale form consists of 3 sub-dimensions and 21 items. The sub-dimensions consist of perceived heart attack and stroke risk, healthy eating intentions, perceived benefits and intentions to change. A maximum score of 64 and a minimum score of 0 can be obtained from the scale. A higher score on the scale and its sub-dimensions indicates an increased awareness of cardiovascular diseases.
  measure: Cardiovascular risk perception
  time frame: at the end of 0th, 6th, and 12th weeks
  description: Perceived cardiovascular disease risk in the next 10 years is questioned as low, moderate, high and very high.
  measure: International Physical Activity Questionnaire Scores
  time frame: at the end of 0th, 6th, and 12th weeks
  description: The international physical activity questionnaire (Short Form) consists of 7 questions. The questionnaire asks about the number of days of vigorous, moderate, mild physical activity in the last 7 days and how much of the day, and how much time is spent sitting in individuals who do not engage in physical activity. It provides the calculation of the energy expended by the activities in meters. A high score on the scale form indicates being active in physical activity.
  measure: Beck Anxiety Scale Scores
  time frame: at the end of 0th, 6th, and 12th weeks
  description: The scale form consists of 21 questions on a 4-point Likert scale (0=none, 3=seriously) about anxiety symptoms in the last one week.
  measure: Cardiovascular disease risk factors
  time frame: at the end of 0th, 6th, and 12th weeks
  description: anthropometric measurements weight (Kilograms)
  measure: Cardiovascular disease risk factors
  time frame: at the end of 0th, 6th, and 12th weeks
  description: anthropometric measurements height (meter)
  measure: Cardiovascular disease risk factors
  time frame: at the end of 0th, 6th, and 12th weeks
  description: anthropometric measurements hip circumference (centimeters)
  measure: Cardiovascular disease risk factors
  time frame: at the end of 0th, 6th, and 12th weeks
  description: anthropometric measurements waist circumference (centimeters)
  measure: Cardiovascular disease risk factors
  time frame: at the end of 0th, 6th, and 12th weeks
  description: blood pressure (mmHg)
  arm group label: Intervention/treatment
  arm group type: Experimental
  description: Health education, mobile applications, monitoring, Cardiovascular disease risk assessment
  arm group label: Active group
  arm group type: Active Comparator
  description: Cardiovascular disease risk assessment
  intervention type: Other
  intervention name: Cardiovascular disease risk assessment
  description: Cardiovascular disease risk assessment
  Training and Consultancy Based on the literature, the researcher prepared a Training Guide for the Prevention of Cardiovascular Diseases, including the subjects of Cardiovascular Diseases and Risk Factors, Physical Activity, Smoking and Heart Health, BMI and Heart Health, Nutrition, and Stress. By using the training guide, training time for individual training intervention will be planned for one day of the week with the participants. Individual training will last 30 minutes at the stops with waiting areas during the working hours of the participants.
  Mobile Application To the participants in the intervention group 2, 4. In the 6th and 6th weeks, text messages will be shared once a week to increase motivation and prevent cardiovascular diseases.
  Monitoring Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.
  arm group label: Active group
  arm group label: Intervention/treatment
  intervention type: Other
  intervention name: Training and Consultancy
  description: Based on the literature, the researcher prepared a Training Guide for the Prevention of Cardiovascular Diseases, including the subjects of Cardiovascular Diseases and Risk Factors, Physical Activity, Smoking and Heart Health, BMI and Heart Health, Nutrition, and Stress. Using the training guide, training time for individual training intervention will be planned for one day of the week with the participants. Individual training will last 30 minutes at the stops with waiting areas during the participants' working hours.
  arm group label: Intervention/treatment
  intervention type: Other
  intervention name: Mobile Application
  description: To the participants in the intervention group 2, 4. In the 6th and 6th weeks, text messages will be shared once a week to increase motivation and prevent cardiovascular diseases.
  Text Messages Week 2 "Tobacco use causes 6 million deaths in the world. The risk of death is reduced by 90% in those who stop using tobacco. Alcohol use causes damage to the heart muscle, arrhythmia, and stroke. For a healthy life, you should stay away from smoking and alcohol. ' Week 4 '' Inadequate physical activity increases the risk of death from all causes. Physical activity reduces the risk of hypertension, stroke, and depression. 30 minutes of moderate-intensity physical activity daily is recommended.
  Week 6 "Adequate consumption of vegetables and fruits reduces the risk of cardiovascular disease. Saturated and trans fats increase the risk of cardiovascular disease. It is recommended to consume <5 g less per day to prevent cardiovascular diseases.
  arm group label: Intervention/treatment
  intervention type: Other
  intervention name: Monitoring
  description: Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.
  arm group label: Active group
  arm group label: Intervention/treatment
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Necmettin Erbakan University
  investigator full name: Serdar ulak
  investigator title: lecturer
  mesh term: Cardiovascular Diseases
  sharing ipd: No