Evaluating the effect of a health-promoting behavioural programme on student's quality of life, academic self-efficacy and health: Study protocol of the PROMESS-Group randomised controlled trial

Background: Medical and doctoral students in health sciences represent a strategic public health lever as future professionals who will have a lasting influence on healthcare practices and the overall quality of health systems. Impaired quality of life and mental health issues among these students, coupled with scarce prevention programmes, led us to develop PROMESS-Group, an innovative multimodal programme designed to promote healthier lifestyle habits among university students. Methods: We will conduct a 2-arm randomised, controlled, superiority monocentric trial to assess the effect of this programme on medical and doctoral students compared to a control group. The intervention will consist of six sessions covering stress, sleep and physical activity domains. Each session will include group and individual meetings led by trained peer experts, focusing on needs assessment, self-care education, and personalised goals setting. Students' quality of life, academic self-efficacy, and broader health outcomes will be assessed using validated questionnaires and objective tools at baseline, during, and post-intervention. Data will be analysed according to the intention-to-treat principle and presented in accordance with CONSORT guidelines. Ethical approval was obtained from the institutional review board (IRB2025021802). All procedures will be performed in adherence to the Helsinki Declaration. Discussion: This study will enable the generation of high-quality evidence to evaluate the programme's effects on students' quality of life and related psychosocial outcomes, and may inform evidence-based health promotion strategies in university settings. Trial registration: ClinicalTrials.gov: NCT07030751 (https://clinicaltrials.gov/study/NCT07030751?locStr=Lyon,%20France&country=FR&state=Auvergne-Rh%C3%B4ne-Alpes&city=Lyon&cond=promess%20group&rank=1), 06.12.2025 - retrospectively registered. This protocol study follows the SPIRIT guidelines (Appendix 1). Keywords: Doctoral student, health behaviour, medical student, quality of life, physical activity, sleep, stress