Education and Literacy for an Active Life (Educação e Literacia Para Uma Vida Ativa) (ELeVA)

Lusofona University

Status: Active, not recruiting

Conditions: Physical Activity; Sedentary Behaviors; Nutrition; Sleep; Mental Health; Health Literacy

Treatments: Behavioral: Education and Literacy for an Active Life

Study type: Interventional

Funder types: Other

Identifiers

NCT07100535

FEFD16012024

Details and patient eligibility

About

Health literacy is essential for children to develop healthy behaviors that persist into adulthood. It enables the access, understanding, evaluation, and application of health-related information, being a key component of health education.

This study was designed as a randomized controlled study, aiming to analyze the effectiveness and feasibility of a school intervention to improve health literacy of 5th and 6th grade students on nutrition, physical activity, sleep, and mental health. Intervention will be delivered in two phases. Phase 1 will involve a pilot intervention comprising four sessions conducted over a three-month period in two schools representing distinct socioeconomic contexts. Phase 2 will scale the intervention nationally, expanding to include additional schools across Portugal. This phase will include eight sessions conducted over one entire school-year (September-June), and will integrate adjustments based on the limitations and insights identified during the pilot study. Phase 2 will additionally include 20-month follow-up assessments to be performed at the end of the following school-year (20-month).

Enrollment: 128 estimated patients

Sex: All

Ages: 9 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Enrolled in the classes of the included schools
• Agreed to participate
• Informed consent/assent signature

Exclusion criteria

• Severe cognitive or learning disabilities (significant impairment of the ability to engage with the intervention content or complete assessment tools)
• Absenteeism (missing ≥30% of the scheduled sessions)
• Concurrent participation in similar interventions (concurrent enrolment in other structured health, nutrition, or mental health programs that could confound study results)

Note: students with medical conditions that limit their ability to participate in physical activities will not be excluded. The presence of such conditions will be further considered in the analysis.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

Education and Literacy for an Active Life

Experimental group

Description:

Participants will be exposed to 50-minute sessions (only four sessions in Phase 1), targeting health literacy (across the four dimensions: access, comprehension, evaluation and application) on nutrition, sedentary behaviour, physical activity, sleep and mental health. Sessions will use interactive and student-centred methodologies, such as discussions, videos, practical activities, and group work, to promote participation and active learning. The intervention will be implemented uniformly across schools with the support of teachers. Activities will be adapted to the school context and age group to ensure feasibility and relevance.

Treatment:

Behavioral: Education and Literacy for an Active Life

Standard School Curriculum

No Intervention group

Description:

Participants will not receive the health literacy intervention during the study period, receiving only standard school curriculum.