The Effect of Women's Heart Health Awareness Program

NCT07502911 | Not Yet Recruiting

• 1 other identifier: LokmanHekimU-Hem-NO-03
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Health; Cardiovascular Risk Factors; Health Literacy

Keywords

Cardiovascular diseases; women's health; health literacy

Outcome Measures

Primary Outcomes (4)

• Change in knowledge sub-dimension scores of the Cardiovascular Disease KAP Scale from baseline to post-intervention.

  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

  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

  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

  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 Outcomes (1)

• Change in Health Literacy Scale-Short Form scores from baseline to post-intervention

  Baseline (Week 0) and at the end of the 3-week intervention period

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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

Interventions

Heart Health Awareness Program BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim Universty

Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Nurbanu Odacı

CONTACT

+904448548; nur_banu_odaci@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is designed as single-blind at the participant level. The data collection process will be conducted by independent individuals outside of the research team who are unaware of the participants' group assignments. However, the Principal Investigator, who will analyze and evaluate the data, is not blinded as they are aware of the group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This is a cluster randomized study. Randomization was performed at the center level rather than at the individual level.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: April 6, 2026
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)