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

NCT06894134 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Cardiovascular Diseases
  • Obesity Prevention
  • Sedentary Behaviors
  • Sleep Perception
  • Alcohol Abuse
  • Drug Abuse
  • Physical Inactivity

Interventions

OTHER

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

Sponsors & Collaborators

  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894134 on ClinicalTrials.gov