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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06000436
Other study ID # NecmettinEU70
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2023
Est. completion date March 2024

Study information

Verified date November 2023
Source Necmettin Erbakan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Cardiovascular Risk Reduction Program (CARDIOREP) aims to raise risk awareness and reduce risk factors.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Not having been diagnosed with cardiovascular disease. - Using a smartphone. - Agree to use the Google Fit App. Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiovascular Disease Risk Awareness Rating Scale Scores 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 Cardiovascular risk perception 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
Secondary International Physical Activity Questionnaire Scores 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
Secondary Beck Anxiety Scale Scores 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
Secondary Cardiovascular disease risk factors anthropometric measurements weight (Kilograms) at the end of 0th, 6th, and 12th weeks
Secondary Cardiovascular disease risk factors anthropometric measurements height (meter) at the end of 0th, 6th, and 12th weeks
Secondary Cardiovascular disease risk factors anthropometric measurements hip circumference (centimeters) at the end of 0th, 6th, and 12th weeks
Secondary Cardiovascular disease risk factors anthropometric measurements waist circumference (centimeters) at the end of 0th, 6th, and 12th weeks
Secondary Cardiovascular disease risk factors blood pressure (mmHg) at the end of 0th, 6th, and 12th weeks
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