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临床试验/NCT07781280
NCT07781280已完成不适用

Effectiveness of the "Healthy Heart, Healthy Life" Program on Cardiovascular Health Behaviors: A Randomized Controlled Study in Middle School Students

Bilecik Seyh Edebali Universitesi1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
1
主要终点
Change in cardiovascular health behavior measured by the Cardiovascular Health Behavior Scale for Children (CHBSC)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

None (Open Label)

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change in cardiovascular health behavior measured by the Cardiovascular Health Behavior Scale for Children (CHBSC)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aslı Akdeniz Kudubeş

ASSOC.PROF.DR.

Bilecik Seyh Edebali Universitesi

研究点 (1)

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