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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06071351
Other study ID # 07/07/2023- 7/51
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date March 21, 2024

Study information

Verified date December 2023
Source Mus Alparlan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date March 21, 2024
Est. primary completion date March 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Being aged between 40 and 70 years, - Being voluntary to participate in the study, Exclusion Criteria: - Having a known and diagnosed CVD - Not being voluntary to participate in the study.

Study Design


Intervention

Other:
motivational interviewing based training program
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 practice
An informative brochure prepared by the researcher was given.

Locations

Country Name City State
Turkey Kepez Devlet Hastanesi Antalya

Sponsors (1)

Lead Sponsor Collaborator
Mus Alparlan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
24 week
Secondary 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."
24 week
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