Well-Being, PsychologicalMy LifeNCT07411677
My Life - I Decide: A Health Promoting School Intervention
A study testing The My Life intervention in people with Well-Being, Psychological and Dietary Habits, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
Background The proportion of young people experiencing poor mental health and well-being is increasing, placing this group at high risk of not completing secondary education. Educational attainment and health status are strongly correlated, underscoring the need for interventions to address this development. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Well-Being, Psychological, Dietary Habits, Physical Activity
- What is being tested?
- The My Life intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jan 2025to 31 Dec 2026
- 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 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled into a 10th grade class in participating schools
Who cannot join
- Ability to read and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: My Life - I Decide: A Health Promoting School Intervention to Promote Physical and Mental Health and Well-being Among Danish 10th Grade Students.
Background
The proportion of young people experiencing poor mental health and well-being is increasing, placing this group at high risk of not completing secondary education. Educational attainment and health status are strongly correlated, underscoring the need for interventions to address this development. Approximately half of Danish 10th grade students report feeling tired of school, while one in four report pressure and low academic confidence. Schools represent a unique setting for health promotion by enhancing social and emotional competencies, emphasizing the necessity of positioning the school as a health-promoting environment for 10th grade students.
Read more
In one Danish local community, a teaching component focused on life-skills for 10th grade students has been developed and tested over several years. Positive outcomes have been reported, although the experiences also revealed a need for organizational and structural changes to support implementation and enhance impact. Research supports such approaches, recommending whole-school interventions that emphasize health-promoting structures both within the school and in the broader community.
The My Life Initiative
My Life - I Decide is a health-promoting school intervention targeted at 10th grade students in Denmark. The purpose of the My Life research project is to develop and evaluate the processes, effects, and scalability of a health-promoting school intervention aimed at improving physical and positive mental health and school well-being among 10th grade students.
The intervention is based on a health-promoting school approach and incorporates teaching inspired by outdoor-based learning, the life psychological method, action learning, and continuous evaluation and implementation of health-promoting actions at class, school, and community levels.
The health and well-being curriculum consists of 28 lessons delivered over 8-10 weeks. The program focuses on ten life-skills designed to strengthen self.efficacy, social, emotional, and health-related competencies and school well-being. Lessons are delivered by a local community health consultant in close collaboration with one or more 10th grade teachers. This organizational structure has been well-received, as it injects new energy into teaching, strengthens cooperation between schools and local communities, and builds teacher capacity.
Implementation of health-promoting actions at the school and community levels is facilitated through an evidence-based, system-oriented co-creation process. This process involves representatives from schools (teachers, students, and leadership), local community health consultants and coordinators, and civil society actors. The aim is to create health-promoting environments that support students' physical and positive mental health and school well-being through structural and organizational changes.
Collaboration and Research Design
Collaborators include Steno Diabetes Center Copenhagen, the Intersectoral Prevention Laboratory, and ten local communities in the West and South regions. This formalized practice and research collaboration aims to further develop the initiative in a pilot study, followed by an evaluation of its effectiveness using a controlled waitlist design. The project will generate knowledge on how, and under which circumstances, the initiative produces the desired effects, and whether national implementation is feasible.
The intervention project runs for 1.5 years, with research examining impact through a controlled waitlist design involving approximately 26 classes and 500 students. Intervention classes will implement the initiative in 2025/2026, while waitlist classes will implement it in 2026/2027.
Impact will be tracked through electronic student questionnaires administered at three time points: baseline (start of the school year), mid-point (before Christmas), and follow-up (before summer break). A process evaluation will assess implementation, contextual adaptation, and mechanisms of change using interviews, focus groups, observations, and surveys.
Data will be analyzed and reported in scientific articles, with findings addressing the overall research objectives and refining a logic model for the initiative to support implementation in other schools.
Read the detailed description
Background
Low mental health and well-being increase the risk of not completing secondary education. Almost every tenth young person in Denmark reports low mental health and well-being, and from 1984-2018, mental health, well-being, and self-reported health have decreased among 15-year-olds. Data from the Danish Health Behavior in School Children Survey 2018 reported that among 15-year-old students, 11% of boys and 20% of girls had low positive mental health measured by the Warwick-Edinburgh Mental Well-Being Scale. Altogether, these factors call for mental health and well-being interventions among young people, as indicated by the priority areas posed in the common Health Agreement between the Capital Region, local communities, and general practice in Denmark.
In Denmark, students who are not ready to attend secondary education have the option to attend 10th grade before embarking on the next steps in life. However, almost half of 10th grade students have been found to be tired of school, and every fourth student felt pressured by the amount of work in school. In addition, students attending municipal 10th grade schools report lower professional self-confidence compared to students at voluntary boarding schools (efterskole), making municipal 10th grade students in need of support to ensure educational readiness and attainment to progress into secondary education.
Improving health among youth has been shown to have positive effects on educational attainment. Positive mental health among adolescents has been associated with educational attainment in adulthood. Health literacy can be seen as an indicator of later health behavior among youth, as higher health literacy scores among Vocational Education and Training students are associated with lower odds of unhealthy behaviors. Mental health promotion initiatives show strong evidence for using the school setting to strengthen positive mental health, including self-efficacy, mental well-being, and social and emotional skills. Targeting 10th grade students therefore has the potential to increase both positive mental health and educational attainment and progression into secondary education.
Students attending 10th grade expect personal and social development in the form of new life-skills, maturity, extroversion, inclusive class communities, and a varied school day with new forms of learning, activities, and movement. This setting therefore presents an ideal opportunity for health promotion initiatives. The Health Promoting Schools (HPS) framework further advocates for using a whole-school approach, ensuring that different socioecological levels are targeted. Nonetheless, implementing whole-school interventions like the HPS remains challenging, often due to tokenistic rather than authentic implementation. Increasing authentic implementation requires interventions sensitive to school contexts, ensuring that teachers experience interventions as acceptable and feasible. However, knowledge remains limited on how and why school-based interventions work or do not work, underlining the need for research investigating both processes and outcomes.
Aim and Objectives
The overall aim of the My Life project is to test whether the comprehensive My Life intervention can be recommended for implementation on a national scale.
The specific objectives of the project are to:
- Test the effectiveness of the intervention in a controlled, waiting-list design at the student level.
- Test impacts at the system level. C) Investigate mechanisms of change at both student and system levels, and examine implementation processes.
The My Life Intervention
My Life - I Decide is a school-based health promotion intervention developed through a practice-research partnership with Vallensbæk local community, Steno Diabetes Center Copenhagen, and the Intersectoral Prevention Laboratory. The intervention is inspired by the Health Promoting Schools (HPS) approach and is implemented over 1.5 years in 10th grade. It consists of four main components: (1) Preparation, (2) Planning, (3) Health Education Program, and (4) Anchoring.
Preparation:
A formal collaboration agreement between schools and local community health departments clarifies roles, resources, and responsibilities. A detailed intervention manual supports implementation.
Planning:
Includes a two-day training program for local community health consultants, establishment of a peer support network, start-up meetings with teachers, and joint planning of the education program tailored to local conditions.
Health Education Program:
Delivered by trained local community health consultants during the first school semester (11-13 weeks). The program consists of 15 sessions (60 minutes each) covering physical and mental health topics such as nicotine, sleep, physical activity, social media, and well-being. Sessions emphasize active participation, group work, and outdoor learning, involving both health consultants and teachers.
Anchoring:
After the program, schools hold a Health Promoting Schools meeting with teachers, health consultants, and management to evaluate and plan health-promoting actions, including school policies, student initiatives, and structural changes.
Design and Power
The effectiveness trial uses a pragmatic controlled waiting-list design, with classes as the assigning unit. Pragmatic trials, also called effectiveness or real-world trials, are designed to determine the effects of interventions under usual conditions, as opposed to the highly controlled conditions of classical efficacy trials. Classes will either be assigned to intervention during the school year 2025/2026 or 2026/2027. During the set-up phase, feasibility of randomization of schools or classes will be established. This aligns with guidelines recommending non-randomized designs when practical circumstances do not allow highly controlled studies. Matching will be considered based on school comparability in terms of student numbers and socio-economic status, maintaining a pragmatic approach and seeking equal distribution across intervention (early starters) and controls (later starters).
Eight schools with a total of 26 classes and approximately 500 students will participate.
Outcomes and Measurements
Student-level outcomes will be assessed via online surveys at three time points:
Baseline (September 2025): 1-2 weeks after class formation, prior to the health education and anchoring components.
Mid-intervention (Time 1, T1) (Nov-Dec 2025): Immediately after completion of the health education program.
Follow-up (Time 2, T2) (March-April 2026): 7-8 months after baseline after full intervention implementation.
Data will be collected simultaneously in intervention and control schools. Surveys will be administered during a 45-minute class session under exam-like conditions. Students will complete questionnaires via REDCap using headphones and guided video instructions. Investigators and trained interns will supervise to ensure standardized conditions and provide technical support.
System-level impacts will be assessed using the validated Health Promoting School Practices and Capacity (HPS-Q) tool. The tool includes 24 items across seven subdimensions: school policies, ethos, collaboration/involvement, school practice, quality of delivery, resources, and health services. Items were adapted to fit the My Life intervention. Respondent characteristics such as gender, age, teaching subjects, and work experience will also be collected.
Baseline: April-August 2025 (with an additional round in August for newly employed staff).
Follow-up: April-May 2026. All staff working with 10th grade students will be invited to complete an online survey.
Qualitative data will be collected to capture intended and unintended system-level effects:
Semi-structured interviews (n=16) with teachers, health consultants, and school/local community managers in May-June 2026.
Realist Ripple Effects Mapping (RREM) workshop in May-June 2026 with teachers, school management, and health consultants to trace causal pathways and map unanticipated outcomes. If not feasible, short structured interviews with school and local community coordinators will be conducted instead.
Process Evaluation
The process evaluation will examine:
Implementation of the intervention across diverse school settings (fidelity, reach, acceptability).
Mechanisms triggered at the student level during and after implementation.
Mechanisms triggered at the system level for longer-term impact.
A realist-informed approach will be applied, combining deductive, inductive, and theory-driven analyses to explore how context and mechanisms produce outcomes.
Cross-Sectoral Collaboration and Organization
Collaborators include Steno Diabetes Center Copenhagen (SDCC, principal investigator), the Intersectoral Prevention Laboratory (TIPL, co-investigator), and Vallensbæk local community. Vallensbæk, HS, and a daily project coordinator are responsible for practice-related parts, including intervention implementation, consultant training, and coordination between local communities. SDCC is responsible for research and evaluation activities, in close dialogue with practice. A steering committee, consisting of representatives from TIPL, SDCC, HS, local communities, and 10th grade schools, will follow activities, ensure resource allocation and anchoring, and contribute to dissemination. An operating project group consisting of HS and the municipal project coordinator will coordinate intervention and research progress. A research coordination group will meet regularly to ensure progress and quality of research.
Dissemination of Knowledge
Knowledge created will be disseminated to relevant stakeholders, including schools, local communities, and researchers. An external communication plan will ensure representation of student perspectives. Dissemination channels include:
Scientific journals
The Danish Healthy Cities Network
The collaboration of 10 Danish local communities
National and international conferences
Center for Prevention in Practice (Local Government Denmark)
Teacher and supervisor networks within the school system
The Intersectoral Prevention Laboratory annual network meeting
Local newspapers and social media channels
Bilateral meetings with relevant organizations and partners
Legal, Ethical, and Regulatory Demands
The effectiveness trial will be registered in ClinicalTrials.gov. All data will be collected, processed, and securely stored in accordance with the Danish Data Protection Agency and adhere to the Danish Code of Conduct for Research Integrity. The Capital Region of Denmark and SDCC will host all data.
- Being tested
- The My Life intervention
- Keywords
- health promoting school, whole-school approach, health behavior, Adolescents
- Medical subject headings
- Psychological Well-Being, Feeding Behavior, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The My Life interventionBehavioural
Also called My Life - I Decide
My Life - I Decide is a school- and community-based intervention inspired by the Health Promoting Schools (HPS) approach. It runs over one and a half school years in 10th grade and has four components: Preparation, Planning, Health Education Program, and Anchoring. Preparation involves a collaboration agreement between school and municipality. Planning includes consultant training, peer networks, and joint planning with teachers. The education program consists of 15 weekly sessions on physical and mental health, led by consultants with teachers, emphasizing active participation and outdoor learning. Anchoring takes place through a HPS meeting where teachers, consultants, and school leaders plan follow-up actions to sustain and integrate health promotion, e.g. mobile phone policies or breakfast clubs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Schools | Experimental | The My Life intervention consisting of the four phases of preparation, planning, the health education program and anchoring will be delivered at intervention schools. Receives: Behavioral: The My Life intervention |
| Control Schools | No intervention | No intervention will be applied, but according to the wait-list design, the My Life intervention will be implemented in the control schools after follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social-emotional competence
Measured using an index developed for fifth-ninth grade students by Nielsen et al. 2015. Item scores are combined into a single index score ranging from 0 to 9, with higher scores indicating stronger social-emotional competence.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Self-efficacy
Measured using the validated Self-Efficacy Scale from the Danish cont-ribution to the Health Behaviour in School-aged Children (HBSC) survey. Items are combined into a single total scale score ranging from 2 to 10, with higher scores indicating higher self-efficacy.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Mental well-being
Measured using the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS), validated in a Danish population (50). Items are summed to create a single total score ranging from 7 to 35, with higher scores reflecting better mental well-being.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Physical health (health literacy)
Physical Health was measured using health literacy as both an indicator and determinant of health. We used the validated Danish version of the Health Literacy for School-aged Children (HLSAC) instrument covering five aspects: theoretical knowledge, practical knowledge, critical thinking, self-awareness, and citizenship. The HLSAC is a validated 10-item instrument assessing health literacy among children and adolescents. Each item is rated on a 4-point Likert scale (1 = Not at all true, 4 = Absolutely true). Items are summed to create a single total score ranging from 10 to 40, with higher scores indicating higher health literacy.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Positive student interpersonal relations
Measured using a five-item student support scale from the HBSC study. Items are summed to create a single total score ranging from 5 to 25, with higher scores indicating stronger perceived support from peers.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Positive student-teacher relations
Measured using a three-item teacher relatedness scale from the HBSC study. Items are summed to create a single total score ranging from 3 to 15, with higher scores indicating greater perceived support from teachers. Both the student support and teacher relatedness scales have demonstrated adequate validity and reliability in samples of 13- and 15-year-old students.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
School connectedness
Measured using a three-item connectedness scale from the HBSC study. The Items are summed to create a single total score ranging from 3 to 15, with higher scores reflecting stronger connectedness to school. The scale has previously shown adequate reliability in a sample of 10- to 12-year-old students.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Secondary outcomes (5)
Physical activity
Physical activity was measured with two items. Responses were scored on a 4-point scale (1-4), and summarised into a total score ranging from 2-8 with higher scores indicating more frequent activity.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Social media use
Social media use was measured with one item. Responses were scored on a 5-point scale (1-5), with higher scores indicating less frequent use.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Food literacy
Aspects of food literacy were assessed using three adapted items from the validated Food Literacy Questionnaire. Items were scored on a 4-point scale (1-4) and summarised into a total score ranging from 3 to 12, with higher scores indicating greater food literacy.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Smoking
Smoking was measured with one item. Responses were scored on a 3-point scale (1-3), with higher scores indicating less frequent use.
Measured: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Nicotine use
Nicotine use was measured with one item. Responses were scored on a 3-point scale (1-3), with higher scores indicating less frequent use.
Measured: Time Frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months afte
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start30 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A mixed-method, pragmatic controlled waiting list design to assess effectiveness on student level, impact on the systems level and implementation inspired by realist evaluation. The participating classes serves as the unit of allocation.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Vallensbaek Municipality, The Intersectoral Prevention Laboratory
- Responsible party
- Principal investigator, Charlotte Demant Klinker, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411677
- Sponsor's protocol ID
- 158775
- Acronym
- My Life
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Life - I Decide: A Health Promoting School Intervention to Promote Physical and Mental Health and Well-being Among Danish 10th Grade Students.
- ClinicalTrials.gov ID
- NCT07411677
- Acronym / sponsor ID
- My Life / 158775
- Keywords
- health promoting school, whole-school approach, health behavior, Adolescents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Vallensbaek Municipality, The Intersectoral Prevention Laboratory
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 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.
Background
The proportion of young people experiencing poor mental health and well-being is increasing, placing this group at high risk of not completing secondary education. Educational attainment and health status are strongly correlated, underscoring the need for interventions to address this development. Approximately half of Danish 10th grade students report feeling tired of school, while one in four report pressure and low academic confidence. Schools represent a unique setting for health promotion by enhancing social and emotional competencies, emphasizing the necessity of positioning the school as a health-promoting environment for 10th grade students.
In one Danish local community, a teaching component focused on life-skills for 10th grade students has been developed and tested over several years. Positive outcomes have been reported, although the experiences also revealed a need for organizational and structural changes to support implementation and enhance impact. Research supports such approaches, recommending whole-school interventions that emphasize health-promoting structures both within the school and in the broader community.
The My Life Initiative
My Life - I Decide is a health-promoting school intervention targeted at 10th grade students in Denmark. The purpose of the My Life research project is to develop and evaluate the processes, effects, and scalability of a health-promoting school intervention aimed at improving physical and positive mental health and school well-being among 10th grade students.
The intervention is based on a health-promoting school approach and incorporates teaching inspired by outdoor-based learning, the life psychological method, action learning, and continuous evaluation and implementation of health-promoting actions at class, school, and community levels.
The health and well-being curriculum consists of 28 lessons delivered over 8-10 weeks. The program focuses on ten life-skills designed to strengthen self.efficacy, social, emotional, and health-related competencies and school well-being. Lessons are delivered by a local community health consultant in close collaboration with one or more 10th grade teachers. This organizational structure has been well-received, as it injects new energy into teaching, strengthens cooperation between schools and local communities, and builds teacher capacity.
Implementation of health-promoting actions at the school and community levels is facilitated through an evidence-based, system-oriented co-creation process. This process involves representatives from schools (teachers, students, and leadership), local community health consultants and coordinators, and civil society actors. The aim is to create health-promoting environments that support students' physical and positive mental health and school well-being through structural and organizational changes.
Collaboration and Research Design
Collaborators include Steno Diabetes Center Copenhagen, the Intersectoral Prevention Laboratory, and ten local communities in the West and South regions. This formalized practice and research collaboration aims to further develop the initiative in a pilot study, followed by an evaluation of its effectiveness using a controlled waitlist design. The project will generate knowledge on how, and under which circumstances, the initiative produces the desired effects, and whether national implementation is feasible.
The intervention project runs for 1.5 years, with research examining impact through a controlled waitlist design involving approximately 26 classes and 500 students. Intervention classes will implement the initiative in 2025/2026, while waitlist classes will implement it in 2026/2027.
Impact will be tracked through electronic student questionnaires administered at three time points: baseline (start of the school year), mid-point (before Christmas), and follow-up (before summer break). A process evaluation will assess implementation, contextual adaptation, and mechanisms of change using interviews, focus groups, observations, and surveys.
Data will be analyzed and reported in scientific articles, with findings addressing the overall research objectives and refining a logic model for the initiative to support implementation in other schools.
Detailed description
Background
Low mental health and well-being increase the risk of not completing secondary education. Almost every tenth young person in Denmark reports low mental health and well-being, and from 1984-2018, mental health, well-being, and self-reported health have decreased among 15-year-olds. Data from the Danish Health Behavior in School Children Survey 2018 reported that among 15-year-old students, 11% of boys and 20% of girls had low positive mental health measured by the Warwick-Edinburgh Mental Well-Being Scale. Altogether, these factors call for mental health and well-being interventions among young people, as indicated by the priority areas posed in the common Health Agreement between the Capital Region, local communities, and general practice in Denmark.
In Denmark, students who are not ready to attend secondary education have the option to attend 10th grade before embarking on the next steps in life. However, almost half of 10th grade students have been found to be tired of school, and every fourth student felt pressured by the amount of work in school. In addition, students attending municipal 10th grade schools report lower professional self-confidence compared to students at voluntary boarding schools (efterskole), making municipal 10th grade students in need of support to ensure educational readiness and attainment to progress into secondary education.
Improving health among youth has been shown to have positive effects on educational attainment. Positive mental health among adolescents has been associated with educational attainment in adulthood. Health literacy can be seen as an indicator of later health behavior among youth, as higher health literacy scores among Vocational Education and Training students are associated with lower odds of unhealthy behaviors. Mental health promotion initiatives show strong evidence for using the school setting to strengthen positive mental health, including self-efficacy, mental well-being, and social and emotional skills. Targeting 10th grade students therefore has the potential to increase both positive mental health and educational attainment and progression into secondary education.
Students attending 10th grade expect personal and social development in the form of new life-skills, maturity, extroversion, inclusive class communities, and a varied school day with new forms of learning, activities, and movement. This setting therefore presents an ideal opportunity for health promotion initiatives. The Health Promoting Schools (HPS) framework further advocates for using a whole-school approach, ensuring that different socioecological levels are targeted. Nonetheless, implementing whole-school interventions like the HPS remains challenging, often due to tokenistic rather than authentic implementation. Increasing authentic implementation requires interventions sensitive to school contexts, ensuring that teachers experience interventions as acceptable and feasible. However, knowledge remains limited on how and why school-based interventions work or do not work, underlining the need for research investigating both processes and outcomes.
Aim and Objectives
The overall aim of the My Life project is to test whether the comprehensive My Life intervention can be recommended for implementation on a national scale.
The specific objectives of the project are to:
- Test the effectiveness of the intervention in a controlled, waiting-list design at the student level.
- Test impacts at the system level. C) Investigate mechanisms of change at both student and system levels, and examine implementation processes.
The My Life Intervention
My Life - I Decide is a school-based health promotion intervention developed through a practice-research partnership with Vallensbæk local community, Steno Diabetes Center Copenhagen, and the Intersectoral Prevention Laboratory. The intervention is inspired by the Health Promoting Schools (HPS) approach and is implemented over 1.5 years in 10th grade. It consists of four main components: (1) Preparation, (2) Planning, (3) Health Education Program, and (4) Anchoring.
Preparation:
A formal collaboration agreement between schools and local community health departments clarifies roles, resources, and responsibilities. A detailed intervention manual supports implementation.
Planning:
Includes a two-day training program for local community health consultants, establishment of a peer support network, start-up meetings with teachers, and joint planning of the education program tailored to local conditions.
Health Education Program:
Delivered by trained local community health consultants during the first school semester (11-13 weeks). The program consists of 15 sessions (60 minutes each) covering physical and mental health topics such as nicotine, sleep, physical activity, social media, and well-being. Sessions emphasize active participation, group work, and outdoor learning, involving both health consultants and teachers.
Anchoring:
After the program, schools hold a Health Promoting Schools meeting with teachers, health consultants, and management to evaluate and plan health-promoting actions, including school policies, student initiatives, and structural changes.
Design and Power
The effectiveness trial uses a pragmatic controlled waiting-list design, with classes as the assigning unit. Pragmatic trials, also called effectiveness or real-world trials, are designed to determine the effects of interventions under usual conditions, as opposed to the highly controlled conditions of classical efficacy trials. Classes will either be assigned to intervention during the school year 2025/2026 or 2026/2027. During the set-up phase, feasibility of randomization of schools or classes will be established. This aligns with guidelines recommending non-randomized designs when practical circumstances do not allow highly controlled studies. Matching will be considered based on school comparability in terms of student numbers and socio-economic status, maintaining a pragmatic approach and seeking equal distribution across intervention (early starters) and controls (later starters).
Eight schools with a total of 26 classes and approximately 500 students will participate.
Outcomes and Measurements
Student-level outcomes will be assessed via online surveys at three time points:
Baseline (September 2025): 1-2 weeks after class formation, prior to the health education and anchoring components.
Mid-intervention (Time 1, T1) (Nov-Dec 2025): Immediately after completion of the health education program.
Follow-up (Time 2, T2) (March-April 2026): 7-8 months after baseline after full intervention implementation.
Data will be collected simultaneously in intervention and control schools. Surveys will be administered during a 45-minute class session under exam-like conditions. Students will complete questionnaires via REDCap using headphones and guided video instructions. Investigators and trained interns will supervise to ensure standardized conditions and provide technical support.
System-level impacts will be assessed using the validated Health Promoting School Practices and Capacity (HPS-Q) tool. The tool includes 24 items across seven subdimensions: school policies, ethos, collaboration/involvement, school practice, quality of delivery, resources, and health services. Items were adapted to fit the My Life intervention. Respondent characteristics such as gender, age, teaching subjects, and work experience will also be collected.
Baseline: April-August 2025 (with an additional round in August for newly employed staff).
Follow-up: April-May 2026. All staff working with 10th grade students will be invited to complete an online survey.
Qualitative data will be collected to capture intended and unintended system-level effects:
Semi-structured interviews (n=16) with teachers, health consultants, and school/local community managers in May-June 2026.
Realist Ripple Effects Mapping (RREM) workshop in May-June 2026 with teachers, school management, and health consultants to trace causal pathways and map unanticipated outcomes. If not feasible, short structured interviews with school and local community coordinators will be conducted instead.
Process Evaluation
The process evaluation will examine:
Implementation of the intervention across diverse school settings (fidelity, reach, acceptability).
Mechanisms triggered at the student level during and after implementation.
Mechanisms triggered at the system level for longer-term impact.
A realist-informed approach will be applied, combining deductive, inductive, and theory-driven analyses to explore how context and mechanisms produce outcomes.
Cross-Sectoral Collaboration and Organization
Collaborators include Steno Diabetes Center Copenhagen (SDCC, principal investigator), the Intersectoral Prevention Laboratory (TIPL, co-investigator), and Vallensbæk local community. Vallensbæk, HS, and a daily project coordinator are responsible for practice-related parts, including intervention implementation, consultant training, and coordination between local communities. SDCC is responsible for research and evaluation activities, in close dialogue with practice. A steering committee, consisting of representatives from TIPL, SDCC, HS, local communities, and 10th grade schools, will follow activities, ensure resource allocation and anchoring, and contribute to dissemination. An operating project group consisting of HS and the municipal project coordinator will coordinate intervention and research progress. A research coordination group will meet regularly to ensure progress and quality of research.
Dissemination of Knowledge
Knowledge created will be disseminated to relevant stakeholders, including schools, local communities, and researchers. An external communication plan will ensure representation of student perspectives. Dissemination channels include:
Scientific journals
The Danish Healthy Cities Network
The collaboration of 10 Danish local communities
National and international conferences
Center for Prevention in Practice (Local Government Denmark)
Teacher and supervisor networks within the school system
The Intersectoral Prevention Laboratory annual network meeting
Local newspapers and social media channels
Bilateral meetings with relevant organizations and partners
Legal, Ethical, and Regulatory Demands
The effectiveness trial will be registered in ClinicalTrials.gov. All data will be collected, processed, and securely stored in accordance with the Danish Data Protection Agency and adhere to the Danish Code of Conduct for Research Integrity. The Capital Region of Denmark and SDCC will host all data.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A mixed-method, pragmatic controlled waiting list design to assess effectiveness on student level, impact on the systems level and implementation inspired by realist evaluation. The participating classes serves as the unit of allocation.
| Arm | Type | Receives |
|---|---|---|
| Intervention Schools | Experimental | Behavioral: The My Life interventionThe My Life intervention consisting of the four phases of preparation, planning, the health education program and anchoring will be delivered at intervention schools. |
| Control Schools | No intervention | –No intervention will be applied, but according to the wait-list design, the My Life intervention will be implemented in the control schools after follow-up. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled into a 10th grade class in participating schools
Key exclusion criteria (1 listed)
- Ability to read and understand Danish
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 |
|---|---|---|
| The My Life interventionAlso: My Life - I DecideMy Life - I Decide is a school- and community-based intervention inspired by the Health Promoting Schools (HPS) approach. It runs over one and a half school years in 10th grade and has four components: Preparation, Planning, Health Education Program, and Anchoring. Preparation involves a collaboration agreement between school and municipality. Planning includes consultant training, peer networks, and joint planning with teachers. The education program consists of 15 weekly sessions on physical and mental health, led by consultants with teachers, emphasizing active participation and outdoor learning. Anchoring takes place through a HPS meeting where teachers, consultants, and school leaders plan follow-up actions to sustain and integrate health promotion, e.g. mobile phone policies or breakfast clubs. | Behavioural | Intervention Schools |
Primary outcome
Social-emotional competence
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Measured using an index developed for fifth-ninth grade students by Nielsen et al. 2015. Item scores are combined into a single index score ranging from 0 to 9, with higher scores indicating stronger social-emotional competence.
Self-efficacy
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Measured using the validated Self-Efficacy Scale from the Danish cont-ribution to the Health Behaviour in School-aged Children (HBSC) survey. Items are combined into a single total scale score ranging from 2 to 10, with higher scores indicating higher self-efficacy.
Mental well-being
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Measured using the Short Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS), validated in a Danish population (50). Items are summed to create a single total score ranging from 7 to 35, with higher scores reflecting better mental well-being.
Physical health (health literacy)
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Physical Health was measured using health literacy as both an indicator and determinant of health. We used the validated Danish version of the Health Literacy for School-aged Children (HLSAC) instrument covering five aspects: theoretical knowledge, practical knowledge, critical thinking, self-awareness, and citizenship. The HLSAC is a validated 10-item instrument assessing health literacy among children and adolescents. Each item is rated on a 4-point Likert scale (1 = Not at all true, 4 = Absolutely true). Items are summed to create a single total score ranging from 10 to 40, with higher scores indicating higher health literacy.
Positive student interpersonal relations
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Measured using a five-item student support scale from the HBSC study. Items are summed to create a single total score ranging from 5 to 25, with higher scores indicating stronger perceived support from peers.
Positive student-teacher relations
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Measured using a three-item teacher relatedness scale from the HBSC study. Items are summed to create a single total score ranging from 3 to 15, with higher scores indicating greater perceived support from teachers. Both the student support and teacher relatedness scales have demonstrated adequate validity and reliability in samples of 13- and 15-year-old students.
School connectedness
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Measured using a three-item connectedness scale from the HBSC study. The Items are summed to create a single total score ranging from 3 to 15, with higher scores reflecting stronger connectedness to school. The scale has previously shown adequate reliability in a sample of 10- to 12-year-old students.
5 secondary outcomes
Physical activity
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Social media use
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Food literacy
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Smoking
Time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.
Nicotine use
Time frame: Time Frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months afte
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 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Well-Being, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
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 The My Life intervention in people with Well-Being, Psychological and Dietary Habits, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 1 inclusion and 1 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 17 Feb 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 Denmark. 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?
Social-emotional competence (time frame: Baseline data will be collected at the earliest 1-2 weeks after class formation and prior to the health education program; mid-intervention (Time 1) approximately 2-3 months after baseline; and follow-up (Time 2) approximately 7-8 months after baseline.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.