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

NCT07100535 | Active Not Recruiting

• 1 other identifier: FEFD16012024
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Keywords

Health literacy; Nutrition; Physical activity; Sedentary behaviours; Sleep; Mental health

Outcome Measures

Primary Outcomes (1)

• Overall health literacy score

  Overall health literacy score, assessed by the Questionnaire on Literacy in Health Behaviours for Children (QLCS-C), specifically developed for this study and adapted to the Portuguese educational and sociocultural context. This instrument is under validation and was designed to evaluate health literacy competences in children aged 9-12 years, encompassing four core health literacy dimensions: access, comprehension, evaluation and application, of health-related information. The instrument covers five critical domains of health promotion relevant to this age group: diet, PA, sedentary behaviour, sleep and mental health and includes a total of 47 items, scored 0-20 points/item, on a total of 0-100 points). The higher the score, the higher the Literacy level. Item development was based on an extensive review of validated instruments and international guidelines.

  Data will be assessed at baseline (before randomisation), at the end of the intervention (for Phase 1: 3-month; for Phase 2: end of the academic year, 8-month) and at follow-up (Phase 2-only: at the end of the following academic year, 20-month).

Secondary Outcomes (5)

• Health Literacy on Nutrition

  Data will be assessed at baseline (before randomisation), at the end of the intervention (for Phase 1: 3-month; for Phase 2: end of the academic year, 8-month) and at follow-up (Phase 2-only: at the end of the following academic year, 20-month).

• Health Literacy on Physical Activity

  Data will be assessed at baseline (before randomisation), at the end of the intervention (for Phase 1: 3-month; for Phase 2: end of the academic year, 8-month) and at follow-up (Phase 2-only: at the end of the following academic year, 20-month).

• Health Literacy on Sedentary Behaviour

  Data will be assessed at baseline (before randomisation), at the end of the intervention (for Phase 1: 3-month; for Phase 2: end of the academic year, 8-month) and at follow-up (Phase 2-only: at the end of the following academic year, 20-month).

• Health Literacy on Sleep

  Data will be assessed at baseline (before randomisation), at the end of the intervention (for Phase 1: 3-month; for Phase 2: end of the academic year, 8-month) and at follow-up (Phase 2-only: at the end of the following academic year, 20-month).

• Health Literacy on Mental Health

  Data will be assessed at baseline (before randomisation), at the end of the intervention (for Phase 1: 3-month; for Phase 2: end of the academic year, 8-month) and at follow-up (Phase 2-only: at the end of the following academic year, 20-month).

Study Arms (2)

Education and Literacy for an Active Life

EXPERIMENTAL

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.

Behavioral: Education and Literacy for an Active Life

Standard School Curriculum

NO INTERVENTION

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

Interventions

Education and Literacy for an Active Life BEHAVIORAL

This study will assess the effectiveness of a school-based health literacy intervention on the four dimensions of health literacy (i.e., access, understanding, evaluation, and application) on diet, sedentary behaviour, physical activity, sleep, and mental health in 5th and 6th graders (aged 9-12), and explored its implementation feasibility.

Also known as: Educação e Literacia para uma Vida Ativa

Education and Literacy for an Active Life

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lusofona University: lead
• Faculty of Medicine of Universidade de Lisboa (FMUL): collaborator

Study Sites (1)

Universidade Lusófona - Centro Universitário Lisboa

Lisbon, Lisbon District, 1749-024, Portugal

Location

Related Publications (4)

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Paruthi S, Brooks LJ, D'Ambrosio C, Hall WA, Kotagal S, Lloyd RM, Malow BA, Maski K, Nichols C, Quan SF, Rosen CL, Troester MM, Wise MS. Recommended Amount of Sleep for Pediatric Populations: A Consensus Statement of the American Academy of Sleep Medicine. J Clin Sleep Med. 2016 Jun 15;12(6):785-6. doi: 10.5664/jcsm.5866.

  PMID: 27250809 BACKGROUND

• Sirajudeen MS, Waly M, Manzar MD, Alqahtani M, Alzhrani M, Alanazi A, Unnikrishnan R, Muthusamy H, Saibannavar R, Alrubaia W. Physical activity questionnaire for older children (PAQ-C): Arabic translation, cross-cultural adaptation, and psychometric validation in school-aged children in Saudi Arabia. PeerJ. 2022 Apr 12;10:e13237. doi: 10.7717/peerj.13237. eCollection 2022.

  PMID: 35433134 BACKGROUND

• Hardy LL, Booth ML, Okely AD. The reliability of the Adolescent Sedentary Activity Questionnaire (ASAQ). Prev Med. 2007 Jul;45(1):71-4. doi: 10.1016/j.ypmed.2007.03.014. Epub 2007 Apr 14.

  PMID: 17532371 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Psychological Well-Being

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Phase 1. Open label. Intervention and assessments will be performed by the core researchers. Phase 2. Intervention will be applied by trained professors (not part of the research team). Assessors will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 3, 2025
• Study Start: February 3, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PT (1)