Motivational Interviewing Effect on Reducing Cardiovascular Disease Risk Factors

December 4, 2023 updated by: Hasan EVCİMEN, Muş Alparlan University

Motivational Interviewing Based Training Program in Adults Effect on Reducing Cardiovascular Disease Risk Factors: A Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Kepez Devlet Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental intervention group
In addition to the informative brochure prepared by the researcher, a 6-session motivational interview-based training program will be given. The training program will include topics such as nutrition, physical activity, smoking and alcohol use.
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.
Active Comparator: Control Group
An informative brochure prepared by the researcher and traditional consultancy services will be provided.
Other: Routine practice
An informative brochure prepared by the researcher was given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change is CVD risk level
Time Frame: 24 week

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity Level
Time Frame: 24 week

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muş Alparlan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

March 20, 2024

Study Completion (Estimated)

March 21, 2024

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/07/2023- 7/51

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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