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Cardiovascular Disease Risk of Awareness

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ClinicalTrials.gov Identifier: NCT06000436
Recruitment Status : Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : November 27, 2023
Sponsor:
Information provided by (Responsible Party):
Serdar ulak, Necmettin Erbakan University

Study Description
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Brief Summary:
The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Other: Cardiovascular disease risk assessment Other: Training and Consultancy Other: Mobile Application Other: Monitoring Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : November 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention/treatment
Health education, mobile applications, monitoring, Cardiovascular disease risk assessment
 Other: Cardiovascular disease risk assessment

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.


Other: 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. 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.

Other: 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.

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.


Other: Monitoring
Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.
Active Comparator: Active group
Cardiovascular disease risk assessment
 Other: Cardiovascular disease risk assessment

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.


Other: Monitoring
Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular Disease Risk Awareness Rating Scale Scores [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    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.


Secondary Outcome Measures :
  1. Cardiovascular risk perception [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    Perceived cardiovascular disease risk in the next 10 years is questioned as low, moderate, high and very high.

  2. International Physical Activity Questionnaire Scores [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    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.

  3. Beck Anxiety Scale Scores [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    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.

  4. Cardiovascular disease risk factors [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    anthropometric measurements weight (Kilograms)

  5. Cardiovascular disease risk factors [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    anthropometric measurements height (meter)

  6. Cardiovascular disease risk factors [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    anthropometric measurements hip circumference (centimeters)

  7. Cardiovascular disease risk factors [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    anthropometric measurements waist circumference (centimeters)

  8. Cardiovascular disease risk factors [ Time Frame: at the end of 0th, 6th, and 12th weeks ]
    blood pressure (mmHg)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Not having been diagnosed with cardiovascular disease.
  • Using a smartphone.
  • Agree to use the Google Fit App.

Exclusion Criteria:

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Serdar ulak, lecturer, Necmettin Erbakan University
ClinicalTrials.gov Identifier: NCT06000436    
Other Study ID Numbers: NecmettinEU70
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: November 27, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases