My Life - I Decide: A Health Promoting School Intervention

NCT07411677 | Active Not Recruiting

• 1 other identifier: 158775
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Well-Being, Psychological; Dietary Habits; Physical Activity; Adolescent Health

Keywords

health promoting school; whole-school approach; health behavior; Adolescents

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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: 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

Study Arms (2)

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.

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.

Interventions

The My Life intervention BEHAVIORAL

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.

Also known as: My Life - I Decide

Intervention Schools

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrolled into a 10th grade class in participating schools

You may not qualify if:

• Ability to read and understand Danish

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Vallensbaek Municipality: collaborator
• The Intersectoral Prevention Laboratory: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Psychological Well-Being; Feeding Behavior; Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavior, Animal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher and Research Group Leader

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: February 17, 2026
• Study Start: January 30, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)