- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06000436
Cardiovascular Disease Risk of Awareness
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Not having been diagnosed with cardiovascular disease.
- Using a smartphone.
- Agree to use the Google Fit App.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention/treatment
Health education, mobile applications, monitoring, 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.
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.
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.
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
|
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.
Daily data from the previous week (cardio score, number of steps) will be taken from the Google Fit application.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at the end of 0th, 6th, and 12th weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at the end of 0th, 6th, and 12th weeks
|
|
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.
|
at the end of 0th, 6th, and 12th weeks
|
|
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.
|
at the end of 0th, 6th, and 12th weeks
|
|
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
|
anthropometric measurements weight (Kilograms)
|
at the end of 0th, 6th, and 12th weeks
|
|
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
|
anthropometric measurements height (meter)
|
at the end of 0th, 6th, and 12th weeks
|
|
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
|
anthropometric measurements hip circumference (centimeters)
|
at the end of 0th, 6th, and 12th weeks
|
|
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
|
anthropometric measurements waist circumference (centimeters)
|
at the end of 0th, 6th, and 12th weeks
|
|
Cardiovascular disease risk factors
Time Frame: at the end of 0th, 6th, and 12th weeks
|
blood pressure (mmHg)
|
at the end of 0th, 6th, and 12th weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NecmettinEU70
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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