Cardiovascular CareNCT07781280
Healthy Heart, Healthy Life" Program on Cardiovascular Health Behaviors
A study testing EDUCATION in people with Cardiovascular Care and Cardiovascular Diseases Health Behavior, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effect of the "Healthy Heart, Healthy Life" education program on the cardiovascular health behaviors of middle school students. A parallel-group, cluster-randomized controlled design was used, with the school as the unit of randomization. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Care, Cardiovascular Diseases Health Behavior
- What is being tested?
- EDUCATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 10 to 15 years
- Attending one of the middle schools included in the study
- No previous education on the study topic
- No diagnosis of heart disease
- Not currently receiving and not previously having received support (e.g. from a psychologist, psychiatrist or dietitian) related to heart health, physical activity, nutrition or stress management
- Written informed consent obtained from both the parent and the child
Who cannot join
- Hearing, visual or intellectual disability
- Absence of a signed parental consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the "Healthy Heart, Healthy Life" Program on Cardiovascular Health Behaviors: A Randomized Controlled Study in Middle School Students
This study evaluated the effect of the "Healthy Heart, Healthy Life" education program on the cardiovascular health behaviors of middle school students. A parallel-group, cluster-randomized controlled design was used, with the school as the unit of randomization. Two middle schools with similar sociodemographic characteristics were allocated 1:1 to the intervention or the control arm. Students aged 10 to 15 years attending these schools were enrolled. The intervention arm received the "Healthy Heart, Healthy Life" education program, delivered in a single day as four class hours of in-person interactive group sessions. The control arm received no program during the study period. Cardiovascular health behaviors were assessed at baseline, immediately after the program, and at the sixth month using the Cardiovascular Health Behavior Scale for Children (CHBSC) and the Visual Cardiovascular Health Behavior Questionnaire for Children (V-CHBQ).
Read the detailed description
Cardiovascular diseases are among the leading causes of mortality and morbidity worldwide. Although they are rare in childhood, the risk factors that underlie them, including unhealthy diet, physical inactivity, sedentary behavior, tobacco exposure and stress, are established during childhood and adolescence. Maintaining these risk factors at optimal levels during childhood is associated with lower cardiovascular morbidity and mortality in later life. Schools therefore provide an important setting for primary prevention, and school nurses have a key role in screening, early detection and health promotion. Intervention-based studies conducted with children remain limited, and most existing research is descriptive or based on adult samples.
The "Healthy Heart, Healthy Life" program is a nurse-led, school-based education module developed by the researchers on the basis of the literature and reviewed by nine experts in pediatrics, cardiology, pediatric cardiology, pediatric nursing, psychiatric nursing and child psychiatry. The program content covers the structure and function of the cardiovascular system, recognition of cardiovascular diseases, cardiovascular risk factors, steps to protect cardiovascular health, early warning signs, and the importance of regular medical check-ups. It is delivered face to face in group sessions over a single day, comprising four class hours, using interactive teaching methods appropriate to the developmental level of middle school students.
A cluster-randomized controlled design was used to prevent contamination between arms. The unit of randomization was the school. Two middle schools comparable in location, student profile and school size were allocated at a 1:1 ratio by an independent researcher using computer-based random number generation; the allocation list was concealed from the research team. Students meeting the eligibility criteria at each school were enrolled into the arm to which their school had been allocated. Outcome data were collected from both arms at baseline, immediately after the program, and at the sixth month. The study was conducted and reported in accordance with the CONSORT guideline.
- Being tested
- EDUCATION
- Keywords
- cardiovascular health, health behavior, middle school students, school-based intervention, school health nursing, health promotion
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDUCATIONOther
EDUCATION MODULE
| Study group | Role | What they receive |
|---|---|---|
| Control (no program) | No intervention | Students in this arm received no education program during the study period and continued their routine school curriculum. No structured heart health procedure was in place at the school. |
| "Healthy Heart, Healthy Life" education program | Experimental | A nurse-led, school-based education module covering the cardiovascular system, cardiovascular diseases and their risk factors, protective health behaviors (nutrition, physical activity, reduction of sedentary time, avoidance of tobacco, self-esteem and stress management), early warning signs, and the importance of regular check-ups. Delivered in one day as four class hours of in-person interactive group sessions. Receives: Other: EDUCATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular health behavior measured by the Cardiovascular Health Behavior Scale for Children (CHBSC)
The Cardiovascular Health Behavior Scale for Children (Celik \& Bektas, 2020) is a 28-item self-report instrument with the subscales nutrition, exercise, sedentary lifestyle, smoking, self-love and stress. Items are rated on a 4-point Likert scale from 1 (Always) to 4 (Never), and 15 items are reverse scored. Total scores range from 28 to 112. Higher scores indicate a higher level of negative behavior for cardiovascular health (28-55 ideal, 56-83 intermediate, 84-112 poor). Cronbach alpha in this study was 0.84.
Measured: Baseline (before the program), immediately after the program (day 1), and 6 months after the program
Secondary outcomes (1)
Change in cardiovascular health behavior measured by the Visual Cardiovascular Health Behavior Questionnaire for Children (V-CHBQ)
The Visual Cardiovascular Health Behavior Questionnaire for Children (Celik \& Bektas, 2020) is a 10-item image-based instrument covering nutrition, physical activity and sedentary lifestyle. Each item offers one cardiovascular-health-positive and one negative option; the positive option scores 1 point and the negative option 0 points. Total scores range from 0 to 10. Higher scores indicate a higher level of positive cardiovascular health behavior. Kuder-Richardson 20 coefficient in this study was 0.76.
Measured: Baseline (before the program), immediately after the program (day 1), and 6 months after the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Dec 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular CareStudies 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
- Cluster-randomized controlled trial. Two middle schools were randomized 1:1 to the intervention or control arm; all eligible students within a school received the allocation of their school.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Akdeniz Kudubeş, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781280
- Sponsor's protocol ID
- AAKUDUBES
- Other IDs
- NO FUNDING
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amoah, J., Said, S., Rampal, L., Manaf, R., Ibrahim, N., Owusu-Agyei, S., & Asante, K. P. (2021). Effects of a school-based intervention to reduce cardiovascular disease risk factors among secondary school students: A cluster-randomized, controlled trial. PloS One, 16(11). https://doi.org/10.1371/JOURNAL.PONE.0259581 Arnaiz, P., Adams, L., Müller, I., Gerber, M., Walter, C., Du Randt, R., Steinmann, P., Bergman, M. M., Seelig, H., Van Greunen, D., Utzinger, J., & Pühse, U. (2021). Sustainability of a school-based health intervention for prevention of non-communicable diseases in marginalised communities: protocol for a mixed-methods cohort study. BMJ Open, 11(10). https://doi.org/10.1136/BMJOPEN-2020-047296 Bebiş, H., Akpunar, D., Özdemir, S., & Kılıç, S. (2013). Bir ortaöğretim okulundaki adölesanların sağlığı geliştirme davranışlarının incelenmesi. Gülhane Tıp Dergisi, 57(2), 139-145. https://doi.org/10.5455/gulhane.43275 Bel-Serrat, S., Mouratidou, T., Santaliestra-Pasías, A. M., Iacoviello, L., Kourides, Y. A., Marild, S., Molnár, D., Reisch, L., Siani, A., Stomfai, S., Vanaelst, B., Veidebaum, T., Pigeot, I., Ahrens, W., Krogh, V., & Moreno, L. A. (2013). Clustering of multiple lifestyle behaviours and its association to cardiovascular risk factors in children: the IDEFICS study. European Journal of Clinical Nutrition, 67(8), 848-854. https://doi.org/10.1038/EJCN.2013.84 Bozdoğan, M. (2019). Okul çağı çocuklarında kardiyovasküler risk faktörlerine yönelik geliştirilen beslenme eğitim modülünün beslenme bilgi düzeyine ve risk faktörlerine etkisi. Marmara Üniversitesi. Campbell, M. K., Grimshaw, J. M., & Elbourne, D. R. (2004). Intracluster correlation coefficients in cluster randomized trials: Empirical insights into how should they be reported. BMC Medical Research Methodology, 4, 1-5. https://doi.org/10.1186/1471-2288-4-9 Celik, I., & Bektas, M. (2026). Effect of a school-based cardiovascular health promotion program on health behaviors in children: A quasi-ex
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the "Healthy Heart, Healthy Life" Program on Cardiovascular Health Behaviors: A Randomized Controlled Study in Middle School Students
- ClinicalTrials.gov ID
- NCT07781280
- Acronym / sponsor ID
- AAKUDUBES
- Keywords
- cardiovascular health, health behavior, middle school students, school-based intervention, school health nursing, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 24 Aug 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.
This study evaluated the effect of the "Healthy Heart, Healthy Life" education program on the cardiovascular health behaviors of middle school students. A parallel-group, cluster-randomized controlled design was used, with the school as the unit of randomization. Two middle schools with similar sociodemographic characteristics were allocated 1:1 to the intervention or the control arm. Students aged 10 to 15 years attending these schools were enrolled. The intervention arm received the "Healthy Heart, Healthy Life" education program, delivered in a single day as four class hours of in-person interactive group sessions. The control arm received no program during the study period. Cardiovascular health behaviors were assessed at baseline, immediately after the program, and at the sixth month using the Cardiovascular Health Behavior Scale for Children (CHBSC) and the Visual Cardiovascular Health Behavior Questionnaire for Children (V-CHBQ).
Detailed description
Cardiovascular diseases are among the leading causes of mortality and morbidity worldwide. Although they are rare in childhood, the risk factors that underlie them, including unhealthy diet, physical inactivity, sedentary behavior, tobacco exposure and stress, are established during childhood and adolescence. Maintaining these risk factors at optimal levels during childhood is associated with lower cardiovascular morbidity and mortality in later life. Schools therefore provide an important setting for primary prevention, and school nurses have a key role in screening, early detection and health promotion. Intervention-based studies conducted with children remain limited, and most existing research is descriptive or based on adult samples.
The "Healthy Heart, Healthy Life" program is a nurse-led, school-based education module developed by the researchers on the basis of the literature and reviewed by nine experts in pediatrics, cardiology, pediatric cardiology, pediatric nursing, psychiatric nursing and child psychiatry. The program content covers the structure and function of the cardiovascular system, recognition of cardiovascular diseases, cardiovascular risk factors, steps to protect cardiovascular health, early warning signs, and the importance of regular medical check-ups. It is delivered face to face in group sessions over a single day, comprising four class hours, using interactive teaching methods appropriate to the developmental level of middle school students.
A cluster-randomized controlled design was used to prevent contamination between arms. The unit of randomization was the school. Two middle schools comparable in location, student profile and school size were allocated at a 1:1 ratio by an independent researcher using computer-based random number generation; the allocation list was concealed from the research team. Students meeting the eligibility criteria at each school were enrolled into the arm to which their school had been allocated. Outcome data were collected from both arms at baseline, immediately after the program, and at the sixth month. The study was conducted and reported in accordance with the CONSORT guideline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial. Two middle schools were randomized 1:1 to the intervention or control arm; all eligible students within a school received the allocation of their school.
| Arm | Type | Receives |
|---|---|---|
| Control (no program) | No intervention | –Students in this arm received no education program during the study period and continued their routine school curriculum. No structured heart health procedure was in place at the school. |
| "Healthy Heart, Healthy Life" education program | Experimental | Other: EDUCATIONA nurse-led, school-based education module covering the cardiovascular system, cardiovascular diseases and their risk factors, protective health behaviors (nutrition, physical activity, reduction of sedentary time, avoidance of tobacco, self-esteem and stress management), early warning signs, and the importance of regular check-ups. Delivered in one day as four class hours of in-person interactive group sessions. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 10 to 15 years
- Attending one of the middle schools included in the study
- No previous education on the study topic
- No diagnosis of heart disease
- Not currently receiving and not previously having received support (e.g. from a psychologist, psychiatrist or dietitian) related to heart health, physical activity, nutrition or stress management
Key exclusion criteria (2 listed)
- Hearing, visual or intellectual disability
- Absence of a signed parental consent form
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 |
|---|---|---|
| EDUCATIONEDUCATION MODULE | Other | "Healthy Heart, Healthy Life" education program |
Primary outcome
Change in cardiovascular health behavior measured by the Cardiovascular Health Behavior Scale for Children (CHBSC)
Time frame: Baseline (before the program), immediately after the program (day 1), and 6 months after the program
The Cardiovascular Health Behavior Scale for Children (Celik \& Bektas, 2020) is a 28-item self-report instrument with the subscales nutrition, exercise, sedentary lifestyle, smoking, self-love and stress. Items are rated on a 4-point Likert scale from 1 (Always) to 4 (Never), and 15 items are reverse scored. Total scores range from 28 to 112. Higher scores indicate a higher level of negative behavior for cardiovascular health (28-55 ideal, 56-83 intermediate, 84-112 poor). Cronbach alpha in this study was 0.84.
1 secondary outcome
Change in cardiovascular health behavior measured by the Visual Cardiovascular Health Behavior Questionnaire for Children (V-CHBQ)
Time frame: Baseline (before the program), immediately after the program (day 1), and 6 months after the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- BackgroundAmoah, J., Said, S., Rampal, L., Manaf, R., Ibrahim, N., Owusu-Agyei, S., & Asante, K. P. (2021). Effects of a school-based intervention to reduce cardiovascular disease risk factors among secondary school students: A cluster-randomized, controlled trial. PloS One, 16(11). https://doi.org/10.1371/JOURNAL.PONE.0259581 Arnaiz, P., Adams, L., Müller, I., Gerber, M., Walter, C., Du Randt, R., Steinmann, P., Bergman, M. M., Seelig, H., Van Greunen, D., Utzinger, J., & Pühse, U. (2021). Sustainability of a school-based health intervention for prevention of non-communicable diseases in marginalised communities: protocol for a mixed-methods cohort study. BMJ Open, 11(10). https://doi.org/10.1136/BMJOPEN-2020-047296 Bebiş, H., Akpunar, D., Özdemir, S., & Kılıç, S. (2013). Bir ortaöğretim okulundaki adölesanların sağlığı geliştirme davranışlarının incelenmesi. Gülhane Tıp Dergisi, 57(2), 139-145. https://doi.org/10.5455/gulhane.43275 Bel-Serrat, S., Mouratidou, T., Santaliestra-Pasías, A. M., Iacoviello, L., Kourides, Y. A., Marild, S., Molnár, D., Reisch, L., Siani, A., Stomfai, S., Vanaelst, B., Veidebaum, T., Pigeot, I., Ahrens, W., Krogh, V., & Moreno, L. A. (2013). Clustering of multiple lifestyle behaviours and its association to cardiovascular risk factors in children: the IDEFICS study. European Journal of Clinical Nutrition, 67(8), 848-854. https://doi.org/10.1038/EJCN.2013.84 Bozdoğan, M. (2019). Okul çağı çocuklarında kardiyovasküler risk faktörlerine yönelik geliştirilen beslenme eğitim modülünün beslenme bilgi düzeyine ve risk faktörlerine etkisi. Marmara Üniversitesi. Campbell, M. K., Grimshaw, J. M., & Elbourne, D. R. (2004). Intracluster correlation coefficients in cluster randomized trials: Empirical insights into how should they be reported. BMC Medical Research Methodology, 4, 1-5. https://doi.org/10.1186/1471-2288-4-9 Celik, I., & Bektas, M. (2026). Effect of a school-based cardiovascular health promotion program on health behaviors in children: A quasi-ex
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDUCATION in people with Cardiovascular Care and Cardiovascular Diseases Health Behavior, run by Bilecik Seyh Edebali Universitesi 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 24 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiovascular health behavior measured by the Cardiovascular Health Behavior Scale for Children (CHBSC) (time frame: Baseline (before the program), immediately after the program (day 1), and 6 months after the program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07781280, which also lists 1 linked publication.
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 24 Aug 2026.