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NCT Number: NCT07502911

The Effect of Women's Heart Health Awareness Program

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.

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Key information

Conditions

Cardiovascular Health Cardiovascular Diseases Cardiovascular Risk Factors Health Literacy

Age range

20 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nurbanu Odacı

CONTACT

[email protected]

+904448548

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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