Clinical Trial

Team-based Learning Intervention to Prevent Risk Factors for Chronic Diseases - a Cluster Randomized Trial

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-18.
Trial Details
NCT Number NCT06894134
Lead Sponsor Professor Fernando Figueira Integral Medicine Institute
Conditions Cardiovascular Diseases, Obesity Prevention, Sedentary Behaviors, Sleep Perception, Alcohol Abuse, Drug Abuse, Physical Inactivity
Enrollment 240 participants
Start Date 2025-09-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-30