क्लिनिकल ट्रायल रडार

Background: Chronic diseases, such as cardiovascular diseases, diabetes, and cancer, are a major global health issue. Their modifiable risk factors, including poor diet, physical inactivity, irregular sleep, tobacco use, and excessive alcohol consumption, often emerge during adolescence and persist into adulthood. Early educational interventions can promote healthy habits and reduce their prevalence. Team-Based Learning (TBL), an active teaching method, has demonstrated effectiveness in improving knowledge and behaviors essential for a healthy lifestyle. Objective: evaluate whether a TBL-based educational intervention can improve adolescents' knowledge and habits related to chronic disease risk factors. Methods: A cluster randomized controlled trial (cRCT) will be conducted in public schools in Palmares, Brazil, targeting high school students aged 15-19 years. Fourteen schools will be randomly assigned to intervention and control groups. The intervention, consisting of four TBL modules, will cover healthy eating, physical activity, screen time, sleep, tobacco, and alcohol use, delivered by graduate nursing students under faculty supervision. Data collection will take place at three time points: pre-intervention, post-intervention, and three months later. The control group will continue receiving standard health education. Primary outcomes will assess behavioral changes, while secondary outcomes will analyze body mass index (BMI) and blood pressure. Analysis: Data will be analyzed using SPSS, with descriptive statistics, paired and unpaired t-tests, ANOVA, and chi-square tests. The analysis will account for clustering and be conducted using intention-to-treat analysis. Statistical significance will be set at p<0.05. Conclusion: The study will provide evidence on TBL as a scalable tool for preventing risk factors in adolescents, contributing to long-term public health benefits.

Introduction Chronic diseases are leading causes of mortality worldwide, affecting both developed and developing countries. Chronic diseases include cardiovascular diseases, diabetes, stroke, cancer and mental diseases. These diseases have been and continue to be the major causes of worldwide morbidity. They significantly strain healthcare systems and contribute to reduce quality of life and workforce productivity. The estimated cost of chronic disease is expected to reach $47 trillion worldwide by 2030.

Modifiable risk factor for chronic diseases are unhealthy diet, physical inactivity and sedentary behavior, irregular sleep, tobacco use, and excessive alcohol consumption. These risk factors usually begin during childhood and adolescence and persist into adulthood. This age period is critical as they become more exposed to external influences, including peers, media, and their environment, while developing autonomy in decision-making. Intervening during these formative years is essential to promote healthier behaviors and prevent chronic diseases in adulthood.

Some studies on educational interventions for adolescents to prevent chronic disease risk factors have demonstrated promising outcomes in different countries. The Health4Life program, which uses web-based modules to address risk factors, showed increased student engagement and knowledge retention. Another study highlighted the importance of combining education with parental and community involvement to achieve more sustainable behavioral changes. However, other studies including systematic review report limited or no significant changes in healthy behaviors.

Team-based learning (TBL) is an active teaching method with a student-centered approach in which students learn about a subject by working in groups to solve an open-ended problem. This educational approach has several advantages compared to the usual education provided by school teachers, such as improved engagement and active learning andencouragement ofcritical thinking and problem-solving skills.By working in teams, students develop collaboration and communication skills, receive immediate feedback, peer learning, andincrease their motivation, accountability and self-confidence. By presenting real-world problems to solve, TBL also results in better practical knowledge and retention, encourages active engagement and self-directed learning, and fairer assessment of diverse perspectives. TBL appears to be appropriate in improving the knowledge, critical thinking and enhancing their skills and behaviours. The hypothesis that TBL can be use to address risk factors for chronic diseases among adolescents, such as unhealthy diets, physical inactivity, sedentary behavior, irregular sleep patterns, tobacco use, and excessive alcohol consumption, was not tested yet. Studies with education intervention applying the TBL method to adolescents students aiming to preventrisk factor for chronic diseases have not yet been conducted. TBL may contribute to Health Behavior Education enhancingadolescents' understanding of the links between lifestyle choices and health outcomes. TBL may also foster a sense of responsibility and self-efficacy, which are critical for adopting healthier habits. In addition to knowledge, TBL may build skills such as problem-solving, communication, and teamwork, which are vital for sustaining healthy habits into adulthood. Despite its advantages, TBL may present some challenges, such asrequiringmore preparation time for both students and instructors, may be challenging to implement in very large classes, some students may struggle with group dynamics or prefer individual learning styles, and assessment and grading may be more complex compared to traditional methods. However, TBL can offer significant advantages over traditional teaching regarding how we deal with a health problem that potentially affects all adolescent students (a risk factor for chronic diseases), being part of their dailylife, which require practical application of knowledge, collaboration, and the development of real world skills.

Based on all this the objective of this study is to verify if an educational intervention, based on TBL, can prevent risk factors (unhealthy diet, physical inactivity, sedentary behavior, excessive screen time, irregular sleep, tobacco use and excessive alcohol use) for chronic diseases may modify the knowledge and habits of adolescent students.

Methods Study design A cluster randomized controlled trial (cRCT) will be performed using an active learning method, TBL, to prevent risk factors for chronic diseases in adolescent students. A cRCT design reduces the potential for contamination between conditions that would be present were individuals randomized. This project will be previously registered at the ClinicalTrials.gov.

Setting and period The study willl be conducted in the public schools of the city of Palmares, Pernambuco state, Brazil. Palmares has shown a commitment to improving adolescent education through various programs and initiatives. The Basic Education Development Index (IDEB), a key indicator of education quality in Brazil, has increase from 3.9 in 2015 to 4.5 in 2021.Palmares has a population of 54,584 inhabitants (IBGE, 2022), and out of 79 schools, 63 are public and 16 are private. A school year in Brazil runs from March to December with one month vacation (July). The school timings are from 7:30 AM to 11:30 PM in the morning and 1:30 PM to 5:30 PM in the afternoon on working days.

Study participants Data collection After obtaining permission to collect data, the researchers will provide details of the study during the class hour, as well as the inclusion and exclusion criteria to adolescent students. They will also provide information about the study to the school's board. The adolescent students and their parents or legal guardians who agreed to participate in the study will respectively sign an informed assent and an informed consent.

Initially a baseline questionnaire (pre-test) will be applied. This questionnaire (attached) will assess: 1 - Food knowledges, based on the Guidelines for the Brazilian Population (MS), and diet habits; 2 - Benefits of physical activity, based on WHO guidelines, and pattern of physical activity (IPAC); 3 - Knowledge of the association between screen time and health, and determination of participant screen time; 4 - Knowledge of the importance of sleep to the health, and sleep pattern;5 -Knowledge of tobacco and alcohol harms to the health, and identification of habits of cigarette smoking and excessive use of alcohol. We will provide individual students with their own identification number to blind their personal information in the answer sheet both for the clinical reasoning and the socioeconomic status. This same questionnairewill be applied immediately after the end of intervention and three months later.

Randomization The study will randomly select 14 public schools from a list of 63. We will use a computer-generated random number sequence to randomly assign one school to the health-promotion intervention and another to the control intervention within pairs. These randomly selected schools (clusters) will be stratified based on the morning/afternoon turn of the adolescent participants. We will randomly allocate an equal number of clusters from each stratum to the intervention and control arms using stratified random sampling.

Sample size Assuming that the mean and standard deviation of the score in the control group are, respectively, equal to 3 and 1.5 points, it can be seen that two samples, each with 4 classes of 30 students, are sufficient to provide a power of 80% to detect a 50% increase in the mean of the treated group in relation to the control group, assuming a significance level of 5% and an intraclass correlation coefficient of 0.10.

Intervention The goal of the health-promotion intervention is to enhance students' knowledge, attitudes, and skills in maintaining a healthy diet, engaging in physical activity, limiting screen time to less than two hours, maintaining a regular sleep schedule, and abstaining from cigarette smoking and alcohol consumption. This intervention will be based on the active learning method, TBL, a teaching method that uses common real-world problems to promote students' acquisition of knowledge, attitudes, and skills.

Graduate students of a nursing school, under the supervision of their teachers, will apply the intervent...

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