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

NCT06894134 | Not Yet Recruiting

• 1 other identifier: IMIP
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

team-based learning; adolescents; prevention; chronic diseases

Outcome Measures

Primary Outcomes (1)

• Knowledge and behaviour of healthy dietary habits, physical activity pattern, regular sleep and no tobaco and excessive alcohol

  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 alcohol per day for men (about 4 standard drinks) and more than 40g for women (about 3 standard drinks)

  6 months

Study Arms (2)

Adolescent students intervention

EXPERIMENTAL

Students adolescent from Plamares public schools, aging 15 to 19 years who will be submitted to a team-based learning method to provide knowledge to prevent chronic diseases at adult life providing health behaviours.

Other: Team-based learning

Control

NO INTERVENTION

Students adolescent from Palmares aging 15 to 19 years who will receive no education intervention

Interventions

Team-based learning OTHER

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

Adolescent students intervention

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Cognitive limitations
• Physical limitations
• Communication limitations
• Use of medications that interfere with eating, physical activity, or sleeping habits.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases; Sedentary Behavior; Alcoholism; Substance-Related Disorders; Chronic Disease

Condition Hierarchy (Ancestors)

Behavior; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joao Guilherme Bezerra Alves, MD

CONTACT

+55 (81) 99974-6351; joaoguilherme@imip.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03