Health LiteracyNCT07601815
MEST : A School- Based Health Literacy Intervention Trial
A study testing MEST Work Strategy in people with Health Literacy and Adolescent Health, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
The purpose of this study is to evaluate the effectiveness of the MEST work strategy in upper secondary schools. MEST is a school based, health promoting intervention delivered by school health services and designed to strengthen students' health literacy and mental well being. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Adolescent Health
- What is being tested?
- MEST Work Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteNorway
- Study dates
- 17 Aug 2026to 30 Sep 2027
- 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students 16-24 years
- Enrolled in participating upper secondary schools
- Able to provide informed consent
Who cannot join
- Not aged 16-24 years
- Not enrolled in participating upper secondary schools
- Did not provide informed consent
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian Institute of Public Health (NIPH)
Levanger, Trøndelag, 7600
About this study
Official title: Improving Health Literacy and Mental Well-Being Among Students in Norwegian Upper Secondary Schools Through the MEST School Health Work Strategy: A Study Protocol for a Cluster-Randomised Controlled Trial
The purpose of this study is to evaluate the effectiveness of the MEST work strategy in upper secondary schools. MEST is a school based, health promoting intervention delivered by school health services and designed to strengthen students' health literacy and mental well being. The study assesses whether implementation of the MEST work strategy results in improved health literacy and mental well being compared with usual school health services.
This study is a pragmatic matched-pair cluster-randomized, parallel-group superiority trial in which upper secondary schools are assigned either to an intervention group implementing the MEST work strategy or to a control group continuing with school health services as usual. Student-reported outcomes are collected using digitally administered questionnaires during school hours at baseline (T0), and at 4-month (T1) and 9-month (T2) follow-up assessments following intervention initiation. Baseline data collection was conducted between August and October 2026.
Read the detailed description
This study is a pragmatic matched-pair cluster-randomized controlled trial conducted in upper secondary schools, with schools serving as the unit of randomization to minimize contamination between students. Schools were randomized within matched pairs to either the intervention or the control arm. Fourteen schools were matched into seven pairs based on school size and educational profile prior to randomization. One additional school agreed to participate after the matching procedure had been completed and could not be matched. This school was therefore randomized independently, with an equal probability (1:1) of allocation to either study arm.
The MEST school health work strategy is a multilevel health promotion and prevention intervention integrated into existing school health services and delivered through face-to-face activities during one school year (2026-2027). The intervention differs from usual school health service practice by implementing a structured process for assessing students' health and well-being. Students complete a digital health and well-being assessment survey, and survey findings are used by school health services to identify priorities and guide the planning, coordination, and delivery of intervention activities.
The intervention is tailored to local needs rather than following a predefined curriculum. Activities may be delivered at school-wide, classroom, group, or individual levels and are implemented in collaboration with school leaders and teachers. Public health nurses are the primary providers of the intervention, although other health and welfare professionals may contribute depending on local resources and organization. School health personnel attend training prior to implementation and receive structured materials to support intervention delivery.
The primary outcome is general health literacy. Secondary outcomes include positive mental health literacy and mental well-being. Prespecified subgroup and moderator analyses will examine potential effect modification by gender, socioeconomic status, and minority, Indigenous, or immigrant background. Additional exploratory analyses will assess whether variation in intervention dose is associated with study outcomes. Outcome data are reported by students, while information on intervention dose is obtained from school health services.
Simulation-based power analyses were conducted for the matched cluster-randomized design. At the planning stage, analyses based on 12 schools indicated approximately 62-72% power to detect an effect size of d = 0.30 and approximately 80% power to detect an effect size of d = 0.40 for the primary outcome. Following recruitment of 15 schools, updated simulations reflecting the final design yielded estimated power of 67% to detect an effect size of d = 0.30 and 89% power to detect an effect size of d = 0.40.
- Conditions
- Health Literacy, Adolescent Health
- Being tested
- MEST Work Strategy
- Keywords
- Health Promotion, School Health Services, Upper Secondary School
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEST Work StrategyOther
The MEST work strategy is needs-based and adaptive. An anonymous, digitally administered MEST survey conducted prior to intervention initiation informs the selection and tailoring of intervention topics throughout the school year. This survey is used solely to guide intervention delivery and is not included in the outcome evaluation. Intervention activities may include classroom-based sessions, school-wide seminars, small thematic group activities, and individual consultations provided by the school health services, depending on identified student needs. All activities are conducted on school premises using existing school facilities and digital infrastructure.
| Study group | Role | What they receive |
|---|---|---|
| MEST Work Strategy | Experimental | Schools assigned to the intervention arm receive the MEST work strategy delivered by school health services during regular school hours over one school year. The intervention is designed to strengthen students' general health literacy and mental well-being through assessment, planning, and tailored school health service activities, and individual follow-up when needed. Receives: Other: MEST Work Strategy |
| Control- School Health Services as Usual | No intervention | Schools assigned to the control arm continue to provide school health services as usual throughout the study period. Usual care includes routine health promotion and preventive activities and access to individual consultations provided through existing school health services. No components of the MEST work strategy are implemented in control schools during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Health Literacy
General health literacy assessed using the European Health Literacy Survey 2019 for Young People (HLS19-YP12). The instrument consists of 12 items rated on a 4-point Likert scale, with total scores ranging from 12 to 48. Higher scores indicate higher levels of health literacy.
Measured: Baseline (T0), 4 months (T1), and 9 months (T2; primary endpoint)
Secondary outcomes (2)
Positive Mental Health Literacy
Positive mental health literacy using the Positive Mental Health Learning Scale (MHLS-9). The instrument consists of 9 items, each rated on a 5- point Likert scale, giving a total score from 9 to 45, with higher scores indicating higher (better) levels of positive mental health literacy.
Measured: Baseline (T0), 4 months (T1), and 9 months (T2; primary endpoint)
Mental Well-Being
Mental well-being assessed using the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS). The instrument consists of 7 items rated on a 5-point Likert scale. Raw scores range from 7 to 35 and are transformed according to the SWEMWBS scoring procedure. Higher scores indicate greater mental well-being.
Measured: Baseline (T0), 4 months (T1), and 9 months (T2; primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start17 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pragmatic matched pair cluster-randomised parallel-group superiority trial, in which schools constitute the unit of randomization. Schools were randomly allocated within matched pairs in a 1:1 ratio, to the intervention or the controll arm.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hanne N Bjørnsen, RN, MS, MPH, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601815
- Sponsor's protocol ID
- SDAM_FOR555624 /NIPH 6107-6107
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data and relevant analytical code may be shared upon reasonable request, in accordance with applicable data protection regulations and institutional requirements.
Publications
Bjornsen HN, Ringdal R, Espnes GA, Eilertsen MB, Moksnes UK. Exploring MEST: a new universal teaching strategy for school health services to promote positive mental health literacy and mental wellbeing among Norwegian adolescents. BMC Health Serv Res. 2018 Dec 29;18(1):1001. doi: 10.1186/s12913-018-3829-8.
PubMed 30594201
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Literacy and Mental Well-Being Among Students in Norwegian Upper Secondary Schools Through the MEST School Health Work Strategy: A Study Protocol for a Cluster-Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07601815
- Acronym / sponsor ID
- SDAM_FOR555624 /NIPH 6107-6107
- Conditions
- Health Literacy, Adolescent Health
- Keywords
- Health Promotion, School Health Services, Upper Secondary School
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 May 2026 (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.
The purpose of this study is to evaluate the effectiveness of the MEST work strategy in upper secondary schools. MEST is a school based, health promoting intervention delivered by school health services and designed to strengthen students' health literacy and mental well being. The study assesses whether implementation of the MEST work strategy results in improved health literacy and mental well being compared with usual school health services.
This study is a pragmatic matched-pair cluster-randomized, parallel-group superiority trial in which upper secondary schools are assigned either to an intervention group implementing the MEST work strategy or to a control group continuing with school health services as usual. Student-reported outcomes are collected using digitally administered questionnaires during school hours at baseline (T0), and at 4-month (T1) and 9-month (T2) follow-up assessments following intervention initiation. Baseline data collection was conducted between August and October 2026.
Detailed description
This study is a pragmatic matched-pair cluster-randomized controlled trial conducted in upper secondary schools, with schools serving as the unit of randomization to minimize contamination between students. Schools were randomized within matched pairs to either the intervention or the control arm. Fourteen schools were matched into seven pairs based on school size and educational profile prior to randomization. One additional school agreed to participate after the matching procedure had been completed and could not be matched. This school was therefore randomized independently, with an equal probability (1:1) of allocation to either study arm.
The MEST school health work strategy is a multilevel health promotion and prevention intervention integrated into existing school health services and delivered through face-to-face activities during one school year (2026-2027). The intervention differs from usual school health service practice by implementing a structured process for assessing students' health and well-being. Students complete a digital health and well-being assessment survey, and survey findings are used by school health services to identify priorities and guide the planning, coordination, and delivery of intervention activities.
The intervention is tailored to local needs rather than following a predefined curriculum. Activities may be delivered at school-wide, classroom, group, or individual levels and are implemented in collaboration with school leaders and teachers. Public health nurses are the primary providers of the intervention, although other health and welfare professionals may contribute depending on local resources and organization. School health personnel attend training prior to implementation and receive structured materials to support intervention delivery.
The primary outcome is general health literacy. Secondary outcomes include positive mental health literacy and mental well-being. Prespecified subgroup and moderator analyses will examine potential effect modification by gender, socioeconomic status, and minority, Indigenous, or immigrant background. Additional exploratory analyses will assess whether variation in intervention dose is associated with study outcomes. Outcome data are reported by students, while information on intervention dose is obtained from school health services.
Simulation-based power analyses were conducted for the matched cluster-randomized design. At the planning stage, analyses based on 12 schools indicated approximately 62-72% power to detect an effect size of d = 0.30 and approximately 80% power to detect an effect size of d = 0.40 for the primary outcome. Following recruitment of 15 schools, updated simulations reflecting the final design yielded estimated power of 67% to detect an effect size of d = 0.30 and 89% power to detect an effect size of d = 0.40.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pragmatic matched pair cluster-randomised parallel-group superiority trial, in which schools constitute the unit of randomization. Schools were randomly allocated within matched pairs in a 1:1 ratio, to the intervention or the controll arm.
| Arm | Type | Receives |
|---|---|---|
| MEST Work Strategy | Experimental | Other: MEST Work StrategySchools assigned to the intervention arm receive the MEST work strategy delivered by school health services during regular school hours over one school year. The intervention is designed to strengthen students' general health literacy and mental well-being through assessment, planning, and tailored school health service activities, and individual follow-up when needed. |
| Control- School Health Services as Usual | No intervention | –Schools assigned to the control arm continue to provide school health services as usual throughout the study period. Usual care includes routine health promotion and preventive activities and access to individual consultations provided through existing school health services. No components of the MEST work strategy are implemented in control schools during the study period. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Students 16-24 years
- Enrolled in participating upper secondary schools
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Not aged 16-24 years
- Not enrolled in participating upper secondary schools
- Did not provide informed consent
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 |
|---|---|---|
| MEST Work StrategyThe MEST work strategy is needs-based and adaptive. An anonymous, digitally administered MEST survey conducted prior to intervention initiation informs the selection and tailoring of intervention topics throughout the school year. This survey is used solely to guide intervention delivery and is not included in the outcome evaluation. Intervention activities may include classroom-based sessions, school-wide seminars, small thematic group activities, and individual consultations provided by the school health services, depending on identified student needs. All activities are conducted on school premises using existing school facilities and digital infrastructure. | Other | MEST Work Strategy |
Primary outcome
General Health Literacy
Time frame: Baseline (T0), 4 months (T1), and 9 months (T2; primary endpoint)
General health literacy assessed using the European Health Literacy Survey 2019 for Young People (HLS19-YP12). The instrument consists of 12 items rated on a 4-point Likert scale, with total scores ranging from 12 to 48. Higher scores indicate higher levels of health literacy.
2 secondary outcomes
Positive Mental Health Literacy
Time frame: Baseline (T0), 4 months (T1), and 9 months (T2; primary endpoint)
Mental Well-Being
Time frame: Baseline (T0), 4 months (T1), and 9 months (T2; primary endpoint)
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 30 Oct 2026.
- Background: PubMed 30594201Bjornsen HN, Ringdal R, Espnes GA, Eilertsen MB, Moksnes UK. Exploring MEST: a new universal teaching strategy for school health services to promote positive mental health literacy and mental wellbeing among Norwegian adolescents. BMC Health Serv Res. 2018 Dec 29;18(1):1001. doi: 10.1186/s12913-018-3829-8.
- Individual participant dataSharing planned: No. De-identified individual participant data and relevant analytical code may be shared upon reasonable request, in accordance with applicable data protection regulations and institutional requirements.
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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.
Hanne N Bjørnsen, RN, MS, MPH, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEST Work Strategy in people with Health Literacy and Adolescent Health, run by Norwegian Institute of Public Health at 1 site in Norway.
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 3 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 30 Oct 2026. 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 Norway. 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?
General Health Literacy (time frame: Baseline (T0), 4 months (T1), and 9 months (T2; primary endpoint)). 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 NCT07601815, which also lists 1 linked publication.
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 30 Oct 2026.