Cardiovascular HealthNCT07502911
The Effect of Women's Heart Health Awareness Program
A study testing Heart Health Awareness Program in people with Cardiovascular Health and Cardiovascular Risk Factors, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Cardiovascular Risk Factors, Health Literacy
- What is being tested?
- Heart Health Awareness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2026to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Lokman Hekim Universty
Ankara, 06510
Nurbanu Odacı, +90 444 8 548, nur_banu_odaci@hotmail.com
About this study
Official 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
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.
- Being tested
- Heart Health Awareness Program
- Keywords
- Cardiovascular diseases, women's health, health literacy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Health Awareness ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Heart Health Awareness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
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.
Measured: Baseline (Week 0) and at the end of the 3-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start6 Apr 2026 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized study. Randomization was performed at the center level rather than at the individual level.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nurbanu Odacı, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502911
- Sponsor's protocol ID
- LokmanHekimU-Hem-NO-03
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be broadly shared to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07502911
- Acronym / sponsor ID
- LokmanHekimU-Hem-NO-03
- Keywords
- Cardiovascular diseases, women's health, health literacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 6 Apr 2026 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a cluster randomized study. Randomization was performed at the center level rather than at the individual level.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Heart Health Awareness ProgramParticipants 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. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Health Awareness ProgramIntervention 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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).
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).
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be broadly shared to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Health Awareness Program in people with Cardiovascular Health and Cardiovascular Risk Factors, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurbanu Odacı (+904448548, nur_banu_odaci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.