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NCT06894134Not yet recruiting

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

Team-based Learning Intervention in Adolescents to Prevent Risk Factors for Chronic Diseasers - a Cluster Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
240 (estimated)
First submitted
12 Mar 2025
Start date
1 Sept 2025
Primary completion date
30 Sept 2026
Lead sponsor
Professor Fernando Figueira Integral Medicine Institute
Diseases
Obesity
NCT number
NCT06894134

What you commit to

  • Study type: Interventional
  • Planned participants: 240
  • From 1 Sept 2025 to the primary completion date, 30 Sept 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of medications that interfere with eating, physical activity, or sleeping habits.

Other

  • Cognitive limitations
  • Physical limitations
  • Communication limitations

Who the study is looking for

  • Adolescent students of high school
  • Age ranging from 15 to 19 years old.

Age in the registry: 15 years to 19 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.