NCT06071351

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2024

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

September 25, 2023

Last Update Submit

December 4, 2023

Conditions

Keywords

cardiovascular diseasemotivational interviewingrisk reductionnurse's role

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Physical Activity Level

    24 week

Study Arms (2)

Experimental intervention group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

An informative brochure prepared by the researcher and traditional consultancy services will be provided.

Other: Routine practice

Interventions

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.

Experimental intervention group

An informative brochure prepared by the researcher was given.

Control Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being aged between 40 and 70 years,
  • Being voluntary to participate in the study,

You may not qualify if:

  • Having a known and diagnosed CVD
  • Not being voluntary to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepez Devlet Hastanesi

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular DiseasesRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 6, 2023

Study Start

October 1, 2023

Primary Completion

March 20, 2024

Study Completion

March 21, 2024

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations