A Health Promoting School Intervention in 10th Grade ('My Life - I Decide'): Protocol for a Pragmatic Controlled Trial
Clinical Snapshot
PICO Framework
| P — Population | 10th-grade students (aged 15–17 years) attending Danish municipal schools, approximately 416 students across 8 schools (11 intervention classes, 15 control classes) |
| I — Intervention | 'My Life – I Decide' (My Life): a systems-oriented Health Promoting School (HPS) intervention comprising four phases — cross-sectoral preparation, local planning and adaptation, delivery of a curriculum-based health education programme (incorporating action-oriented teaching, life-psychological approaches, and education outside the classroom), and anchoring of health-promoting practices at the school level |
| C — Comparator | Waiting-list control schools receiving no intervention during the study period (matched design, 4 control schools) |
| O — Outcomes | Primary: social and emotional competences, self-efficacy, mental well-being, health literacy, school connectedness, and student interpersonal relations. Secondary/system-level: implementation fidelity, acceptability, intersectoral collaboration, and development of health-promoting school practices |
Bottom Line
This paper describes the protocol for the 'My Life – I Decide' pragmatic controlled trial, a systems-oriented Health Promoting School intervention targeting Danish 10th-grade students. The study's most significant methodological limitation is the absence of randomisation — schools were matched rather than randomly allocated, introducing substantial selection bias risk. With only 8 participating schools, the study is likely underpowered for multilevel analyses, and the protocol lacks explicit sample size justification, MCID thresholds, and ITT analysis plans. Blinding is not feasible in this context, and all primary outcomes rely on student self-report. These limitations are inherent to pragmatic school-based research but must be weighed carefully when interpreting future findings. The study's strengths lie in its comprehensive mixed-methods evaluation framework, theoretically grounded outcome selection, and realist-informed process evaluation — all of which will generate valuable implementation science insights regardless of effectiveness findings. Clinicians and school health practitioners should await the primary outcomes paper before drawing conclusions about intervention efficacy. The evaluation methodology may offer transferable lessons for Australian Health Promoting Schools research, even if direct clinical translation is premature at this protocol stage.
Key Findings
P Value: Not yet available
Effect Size: Not yet available — no effect size data reported in this protocol paper
Primary Outcome: Protocol paper only — no outcome data available. Primary outcomes pre-specified as: social and emotional competences, self-efficacy, mental well-being, health literacy, school connectedness, and student interpersonal relations
Nnt Or Sensitivity: Not calculable from protocol data; no NNT, hazard ratio, or effect measure pre-specified in the abstract
Confidence Interval: Not yet available — confidence intervals will be reported in the primary outcomes paper
Clinical Application
Implementation feasibility depends heavily on the availability of cross-sectoral collaboration between municipal health services and school systems, trained health consultants, and institutional commitment to health-promoting school frameworks. The four-phase model (preparation, planning, delivery, anchoring) requires sustained multi-agency engagement that may be resource-intensive in under-resourced settings. The 'My Life' intervention is not directly applicable to the Australian context in its current form, as it is specifically designed for the Danish Folkeskole 10th-grade system and relies on Danish municipal health service infrastructure. However, the Health Promoting Schools framework underpinning this intervention is endorsed by the Australian Health Promoting Schools Association (AHPSA) and aligns with the Australian Curriculum's Personal and Social Capability strand. Australian schools implementing HPS approaches may draw methodological insights from the evaluation framework, particularly the realist-informed process evaluation and mixed-methods design. The RACGP supports adolescent mental health and preventive health promotion in school settings. No PBS or TGA considerations are relevant as this is a non-pharmacological educational intervention. Australian researchers and school health practitioners should monitor the primary outcomes paper for evidence that may inform local HPS programme design and evaluation. Adolescents aged 15–17 years in secondary school settings, particularly those in systems with established cross-sectoral health and education collaboration infrastructure. Most directly applicable to Danish 10th-grade students in the Folkeskole system; broader applicability to other national contexts requires replication.
Abstract
BACKGROUND: Health promoting school (HPS) interventions have the potential to improve adolescent health and well-being, but evidence regarding implementation and system-level impact in real-world school settings remains limited. "My Life - I Decide" (My Life) is a systems-oriented HPS intervention developed to strengthen positive mental and physical health, school well-being, and health-promoting school practices among 10th-grade students in Denmark. OBJECTIVE: This study aims to describe the intervention, study design, and evaluation framework of the "My Life" intervention and its pragmatic controlled trial, including effectiveness, process, and system-level evaluations. METHODS: The intervention is informed by the World Health Organization HPS framework and combines curriculum-based health education, action-oriented teaching, life-psychological approaches, and education outside the classroom. The intervention includes four phases: (1) preparation through cross-sectoral collaboration between health and education sectors; (2) planning and local adaptation; (3) delivery of a health education program; and (4) anchoring of health-promoting practices at the school level. Effectiveness is evaluated using a pragmatic controlled waiting-list trial design. Four intervention schools (11 classes) were matched with 4 control schools (15 classes), including approximately 416 students aged 15-17 years. Primary outcomes include social and emotional competences, self-efficacy, mental well-being, health literacy, school connectedness, and student interpersonal relations. Student survey data are collected at baseline, postintervention, and follow-up, and effectiveness will be analyzed using multilevel mixed models. System-level impacts are assessed using a mixed-methods design, including school staff surveys, interviews with school and municipal stakeholders, and student focus groups. A realist-informed multimethod process evaluation examines implementation fidelity, acceptability, contextual factors, and mechanisms of impact across intervention schools. Data sources include observations, interviews, student registration, and postsession surveys completed by health consultants after each teaching session. RESULTS: The study will generate quantitative and qualitative data on student outcomes, implementation processes, intersectoral collaboration, and development of health-promoting practices within schools. Findings from the effectiveness, process, and system-level evaluations will be triangulated to test and refine the initial program theory of the intervention. Recruitment of schools and student enrollment have been completed, and baseline data collection commenced in September 2025. Follow-up assessments are being conducted according to the study timeline. Qualitative data collection for the process and system-level evaluations were completed in June 2026. CONCLUSIONS: The "My Life" study will contribute knowledge on the implementation and evaluation of complex HPS interventions in real-world educational settings. The findings may inform future HPS initiatives and provide methodological insights into combining effectiveness, process, and system-level evaluations in adolescent health promotion research.
References
- 1.Stjernqvist, N. W., Timm, A., Hansen, A. B., Bølling, M., Jensen, T. S., Stuart, H., & Demant Klinker, C. (2026). A Health Promoting School Intervention in 10th Grade ('My Life - I Decide'): Protocol for a Pragmatic Controlled Trial. JMIR Research Protocols. https://doi.org/10.2196/52571
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