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

NCT ID: NCT07100535

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-03

Study Completion Date

2029-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Health Literacy Physical Activity Nutrition Sedentary Behaviors Sleep Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Education and Literacy for an Active Life

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.

Group Type EXPERIMENTAL

Education and Literacy for an Active Life

Intervention Type 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.

Standard School Curriculum

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education and Literacy for an Active Life

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Educação e Literacia para uma Vida Ativa

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculty of Medicine of Universidade de Lisboa (FMUL)

UNKNOWN

Sponsor Role collaborator

Lusofona University

OTHER

Sponsor Role lead

Responsible Party

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António Videira-Silva

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Lusófona - Centro Universitário Lisboa

Lisbon, Lisbon District, Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27250809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35433134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17532371 (View on PubMed)

Other Identifiers

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FEFD16012024

Identifier Type: -

Identifier Source: org_study_id

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