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NCT Number: NCT07100535

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

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).

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Key information

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Lusófona - Centro Universitário Lisboa

Lisbon, Lisbon District, 1749-024, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Educação e Literacia para uma Vida Ativa

Primary outcomes

  1. Overall health literacy score

    Time frame: 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).

    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.

Secondary outcomes

  1. Health Literacy on Nutrition

    Time frame: 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 Nutrition will be assessed by the Questionnaire on Literacy in Health Behaviours for Children (QLCS-C). Items on Nutrition (1-20/47) reflect core principles of food literacy and public health nutrition, including nutrient awareness, label reading, and balanced eating habits. Along with categorical analysis, numerical analysis will be also performed (score 0-20). The higher the score, the higher the Literacy level.

  2. Health Literacy on Physical Activity

    Time frame: 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 will be assessed by the Questionnaire on Literacy in Health Behaviours for Children (QLCS-C). Items on Physical Activity (21-30/47) include an adaptation from the Physical Activity Questionnaire for Adolescents - PAQ-A (Kowalski et al., 2004) focusing on knowledge, perceived benefits, obstacles, and engagement in activity. Along with categorical analysis, numerical analysis will be also performed (score 0-20). The higher the score, the higher the Literacy level.

  3. Health Literacy on Sedentary Behaviour

    Time frame: 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 will be assessed by the Questionnaire on Literacy in Health Behaviours for Children (QLCS-C). Items on Sedentary Behaviour (31-33/47) draws from the Adolescent Sedentary Activity Questionnaire - ASAQ (Hardy et al., 2007), adapted to assess screen time and perceived health impacts. Along with categorical analysis, numerical analysis will be also performed (score 0-20). The higher the score, the higher the Literacy level.

  4. Health Literacy on Sleep

    Time frame: 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 will be assessed by the Questionnaire on Literacy in Health Behaviours for Children (QLCS-C). Items on Sleep (34-41/47) were specifically developed for this study, informed by international public health guidelines on sleep hygiene in childhood (Paruthi et al., 2016). These items explore the children's understanding of sleep routines, behaviours, caffeine use, and reliable sources of information on sleep. Although thematically related to constructs evaluated in clinical tools such as the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index - PSQI (Buysse et al., 1989), the purpose of these items is educational, aligned with health literacy competences, and adapted to children's cognitive levels. Along with categorical analysis, numerical analysis will be also performed (score 0-20). The higher the score, the higher the Literacy level.

  5. Health Literacy on Mental Health

    Time frame: 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 will be assessed by the Questionnaire on Literacy in Health Behaviours for Children (QLCS-C). Items on Mental Health (42-47/47) focus on emotional literacy, stress regulation, and social support, with two items adapted from the Flourishing Scale (Diener et al., 2009). Along with categorical analysis, numerical analysis will be also performed (score 0-20). The higher the score, the higher the Literacy level.

Sponsors and collaborators

Lead sponsor

Lusofona University

Other

Collaborators

  • Faculty of Medicine of Universidade de Lisboa (FMUL)

Registry information

Official study title

Education and Literacy for an Active Life

Acronym: ELeVA

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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