Health LiteracyELeVANCT07100535

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

A study testing Education and Literacy for an Active Life in people with Health Literacy and Physical Activity, run by Lusofona University at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 9 to 13 yearsHealthy volunteers can take part
Conditions the study is for: Health Literacy, Physical Activity, Nutrition
What is being tested?: Education and Literacy for an Active Life
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 sitePortugal
Study dates: 3 Feb 2024to May 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 13 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Portugal1 site

Universidade Lusófona - Centro Universitário Lisboa
Lisbon, Lisbon District, 1749-024

Other trials in Portugal

About this study

Official title: Education and Literacy for an Active Life

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
Being tested: Education and Literacy for an Active Life
Keywords: Health literacy, Nutrition, Physical activity, Sedentary behaviours, Sleep, Mental health
Medical subject headings: Motor Activity, Sedentary Behavior, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Education and Literacy for an Active LifeBehavioural
Also called Educação e Literacia para uma Vida Ativa
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.

Study groups in NCT07100535
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 2024May 2029

First posted3 Aug 2025
Study start3 Feb 2024
Primary completionJun 2028 (estimated)
Study completionMay 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Health LiteracyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07100535
Sponsor's protocol ID: FEFD16012024
Acronym: ELeVA
Status last verified: Aug 2025
First submitted: 16 Jul 2025
Last updated: 3 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 2748771
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.
PubMed 27250809
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.
PubMed 35433134
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.
PubMed 17532371

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Education and Literacy for an Active Life
ClinicalTrials.gov ID: NCT07100535
Acronym / sponsor ID: ELeVA / FEFD16012024
Conditions: Health Literacy, Physical Activity, Nutrition, Sedentary Behaviors, Sleep, Mental Health
Keywords: Health literacy, Nutrition, Physical activity, Sedentary behaviours, Sleep, Mental health
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 128 participants (estimated)
Lead sponsor: Lusofona UniversityUniversity, hospital or other
Collaborators: Faculty of Medicine of Universidade de Lisboa (FMUL)
Study start: 3 Feb 2024 (actual)
Primary completion: Jun 2028 (estimated)
Study completion: May 2029 (estimated)
First posted: 3 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Education and Literacy for an Active Life	Experimental	Behavioral: Education and Literacy for an Active LifeParticipants 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.
Standard School Curriculum	No intervention	–Participants will not receive the health literacy intervention during the study period, receiving only standard school curriculum.

Who may qualify

Ages: 9 to 13 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Education and Literacy for an Active LifeAlso: Educação e Literacia para uma Vida AtivaThis 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.	Behavioural	Education and Literacy for an Active Life

Primary outcome

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.

5 secondary outcomes

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 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 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 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 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).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
Results publication: PubMed 2748771Buysse 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.
Results publication: PubMed 27250809Paruthi 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.
Results publication: PubMed 35433134Sirajudeen 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.
Results publication: PubMed 17532371Hardy 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.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Education and Literacy for an Active Life in people with Health Literacy and Physical Activity, run by Lusofona University at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07100535, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.