Healthy Heart, Healthy Life" Program on Cardiovascular Health Behaviors

NCT07781280 | Completed

• 2 other identifiers: AAKUDUBESNO FUNDING
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cardiovascular Care; Cardiovascular Diseases Health Behavior

Keywords

cardiovascular health; health behavior; middle school students; school-based intervention; school health nursing; health promotion

Outcome Measures

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.

  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)

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

Study Arms (2)

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.

Other: EDUCATION

Interventions

EDUCATION OTHER

EDUCATION MODULE

"Healthy Heart, Healthy Life" education program

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Hearing, visual or intellectual disability
• Absence of a signed parental consent form

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Bilecik Şeyh Edebali University

Bilecik, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Health Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC.PROF.DR.

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 24, 2026
• Study Start: December 1, 2025
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)