ClinicalTrials.gg
CompletedNCT07781280Updated Aug 24, 2026

Healthy Heart, Healthy Life" Program on Cardiovascular Health Behaviors

An interventional study of EDUCATION in Cardiovascular Care and Cardiovascular Diseases Health Behavior, sponsored by Bilecik Seyh Edebali Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Bilecik Seyh Edebali Universitesi · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
161
Allocation
Randomized
Ages
10 Years to 15 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 73 studies in Health Behavior with a site in Turkey — 15 open to participants now, 17 under way, none of them phase 3. Health Behavior · Turkey.

Enrollment
9th of 62
161 · median 79
Started
2025
with 14 others
No phase
62 of 73
12 open now
Registered
72nd of 73
by date

Among the 73 studies in Health Behavior with a site in Turkey, this one is the 9th largest by enrollment of the 62 interventional ones that give a count, is one of 15 that started in 2025, is one of 62 with no phase, and was the 72nd registered.

Health Behavior

968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.

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Open to participants now

15 of the 73 studies in Health Behavior with a site in Turkey are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.

This study: 10 Years to 15 Years · all sexes · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • Cardiovascular Care
  • Cardiovascular Diseases Health Behavior

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Keywords

  • cardiovascular health
  • health behavior
  • middle school students
  • school-based intervention
  • school health nursing
  • health promotion
04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 obtained from both the parent and the child

Exclusion criteria

Exclusion Criteria:

  • Hearing, visual or intellectual disability
  • Absence of a signed parental consent form
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
161 participants (actual)

Study arms

  • No intervention
    Control (no program)

    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.

  • Experimental
    "Healthy Heart, Healthy Life" education program

    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.

    Other: EDUCATION

Interventions

  • OtherEDUCATION

    EDUCATION MODULE

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline (before the program), immediately after the program (day 1), and 6 months after the program

07

Study locations

1 site
  • Bilecik Şeyh Edebali University
    Bilecik, Turkey (Türkiye)
08

References and documents

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

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2025 to primary completion in May 2026, 5 months.

Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 5 months is below that.

Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2026
First posted
Aug 24, 2026
StartActual
Dec 1, 2025
Primary completionActual
May 30, 2026
CompletionActual
May 30, 2026
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07781280
Lead sponsor
Bilecik Seyh Edebali Universitesi
Responsible party
Aslı Akdeniz Kudubeş (ASSOC.PROF.DR., Bilecik Seyh Edebali Universitesi) — Principal investigator
First posted
Aug 24, 2026
Start date
Dec 1, 2025
Primary completion
May 30, 2026
Completion
May 30, 2026
Last update
Aug 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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