The Effect of Women's Heart Health Awareness Program

March 25, 2026 updated by: Nurbanu Odacı, Lokman Hekim University

The Effect of a Heart Health Awareness Program on Women's Knowledge, Attitudes, and Practice Toward Cardiovascular Disease and Health Literacy: A Single-Blind Cluster Randomized Controlled Trial

The aim of this study is to examine the effect of a gender-specific heart health protection awareness program, incorporating video-supported reminder messages, on knowledge, attitudes, practices (KAP) regarding cardiovascular diseases and health literacy among adult women aged 20 to 64 with no prior diagnosis of cardiovascular disease. The centers where the study is conducted will be divided into intervention (n=4) and control (n=5) groups using cluster randomization. While the intervention group receives a heart health awareness program consisting of three sessions in total, including education, risk factor screening, and individual counseling over a period of three weeks, the control group will receive standard of care. Data will be collected at the beginning of the first session and after the completion of the final session.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being female,
  • Aged between 20 and 64 years (inclusive),
  • Being literate,
  • Regularly attending any course at the Family Center,
  • Active user of the WhatsApp application.

Exclusion Criteria:

  • Being an immigrant with a Turkish language barrier (unable to communicate in Turkish),
  • Being pregnant,
  • Being in the postpartum period,
  • Having a prior diagnosis of any cardiovascular disease,
  • Having a prior diagnosis of any type of cancer.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Participants in the control group will not receive any intervention during the study and will continue to receive standard services. Data from this group will be collected concurrently with the intervention group at baseline and at the end of the 3rd week. For ethical reasons, following the collection of post-test data, educational brochures will be provided, and a screening session along with brief individual counseling will be conducted for the control group participants.
Experimental: Intervention Group
Participants will receive a heart health awareness program including education on cardiovascular disease prevention, risk factor screening, and brief individual counseling. Pre-test measurements will be taken before the intervention, and post-tests will be administered upon completion of the final session.
Behavioral: Heart Health Awareness Program
Intervention group participants will receive a 3-week program focused on cardiovascular diseases prevention, consisting of 45-minute weekly sessions. The first two sessions are educational sessions involving visual presentations, Q&A, and discussions, with informative brochures provided. To reinforce learning, six reminder video messages will be sent via WhatsApp every two days post-educational sessions. The final session includes a CVD risk screening (height, weight, BMI, waist circumference, blood pressure, and blood glucose) followed by brief individual counseling. Interventions will be conducted simultaneously across all sites by specially trained nurses. Pre-test measurements will be taken before the intervention, and post-tests will be administered upon completion of the final session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in knowledge sub-dimension scores of the Cardiovascular Disease KAP Scale from baseline to post-intervention.
Time Frame: Baseline (Week 0) and at the end of the 3-week intervention period
The knowledge sub-dimension of the scale consists of 12 items designed to assess individuals' knowledge levels regarding cardiovascular disease risk factors and symptoms. Each item is scored as 0, 1, or 2, with total sub-dimension scores ranging from a minimum of 0 to a maximum of 24.
Baseline (Week 0) and at the end of the 3-week intervention period
Change in attitude sub-dimension scores of the Cardiovascular Disease KAP Scale from baseline to post-intervention
Time Frame: Baseline (Week 0) and at the end of the 3-week intervention period
The attitude sub-dimension of the scale consists of 10 items designed to assess individuals' attitudes toward cardiovascular diseases. It utilizes a 5-point Likert-type scale, with total scores ranging from a minimum of 10 to a maximum of 50.
Baseline (Week 0) and at the end of the 3-week intervention period
Change in physical activity behaviors sub-dimension scores of the Cardiovascular Disease KAP Scale from baseline to post-intervention
Time Frame: Baseline (Week 0) and at the end of the 3-week intervention period
The physical activity practices sub-dimension of the scale consists of two items assessing individuals' practices regarding cardiovascular disease risk factors. These items are scored using a 3-point rating scale (0-2).
Baseline (Week 0) and at the end of the 3-week intervention period
Change in diet and smoking behavior behaviors sub-dimension scores of the Cardiovascular Disease KAP Scale from baseline to post-intervention
Time Frame: Baseline (Week 0) and at the end of the 3-week intervention period
The diet and smoking practices sub-dimension of the scale consists of five items assessing individuals' practices regarding cardiovascular disease risk factors. These items are scored using a 3-point rating scale (0-2).
Baseline (Week 0) and at the end of the 3-week intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Health Literacy Scale-Short Form scores from baseline to post-intervention
Time Frame: Baseline (Week 0) and at the end of the 3-week intervention period
The scale consists of 12 items and is scored using a 4-point Likert-type scale (ranging from 1 to 4). The index value is calculated using the formula Index = (Mean - 1) X 50 / 3, resulting in a score between 0 and 50. A higher score represents better health literacy.
Baseline (Week 0) and at the end of the 3-week intervention period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lokman Hekim 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LokmanHekimU-Hem-NO-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be broadly shared to ensure participant confidentiality.

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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