Clinical trial
Team-based Learning Intervention to Prevent Risk Factors for Chronic Diseases - a Cluster Randomized Trial
Opening soon · Not applicable · 0 countries · Registry ID NCT06894134
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Team-based learning
The intervention will include 4 two-hour modules assessing healthy diet, physical activity and screen time, regular sleep, and tobacco and alcohol use. Each module has specific learning objectives (attachment 1). The TBL is a structured active learning approach that fosters collaboration, critical thinking, and accountability. Each module will involve four key steps: (1) Preparation Phase, where students independently will review pre-class materials to build foundational knowledge; (2) Readiness Assurance Process (RAP), which assesses understanding through an individual quiz (iRAT), a team quiz (tRAT), and an instructor-led clarification session; (3) Application Activities
Primary outcomes
The knowledge of the adolescent students will be evaluated by scores, 0 to 10, for each item:health diet, physically active, screen time, sleep regular, smoking and alcohol excess. It will be considered adequate a score equal to or greater than 7.More details are provided in each section on the questionnaire. A healthy dietary habit will be considered adaily consumption of fruits and vegetables, not intake of ultra-processed foods, and not skipping breakfast. The adolescent students will be considered as physically active if they have minimally 150 minutes by week of practicalphysical activity. A sedentary pattern will be considered as a screen time over 2 hours per day. A regular sleep time will be considered as aminimum of 9 hours per day. Regarding smoking and excessive alcohol consumption it will be considered respectively, no smoking and the consumption of more than 60g of pure alc…
Study locations
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