Preventive Remediation for OptiMal StudentS (PROMESS-Group)

Our project aims to help health students to adopt health-promoting behaviors during their studies in a preventive approach. This support will be provided through a multimodal intervention during their curriculum. Specifically, The PROMESS-Group program will be offered to 4th- and 5th-year medical students enrolled at the Faculties of Medicine of Lyon Est and Lyon Sud during the 2024-2025 and 2025-2026 academic years, as well as to PhD students registered in Lyon's health-related doctoral schools.

Voluntary will be randomized into 2 arms (intervention and control). Students in the control group will receive a specific 'compensatory' intervention after the post-intervention period. This intervention will be refined throughout the implementation phase and will consist of a concise yet comprehensive training covering all modules.

The intervention group will follow a preventive program based on three modules: stress management, sleep improvement and fatigue reduction, and sedentary behaviors reduction and physical activity promotion.

This program will span 16 weeks. Both groups will be characterized through a pre-post paradigm multimodal measurement. At the end of this period, we expect improvements in terms of quality of life, physical and mental health, in the interventional arm.

METHODS. POPULATION. The sample size was determined to detect a group × time interaction in a mixed linear model with random intercept for students. The variance parameters and effect size were estimated from preliminary data from a pilot study using the same model (σ²\_ID = 0.315; σ²\_ε = 0.162; β\_interaction = 0.338), corresponding to a standardized effect of d ≈ 0.59. With a two-tailed α risk of 0.05 and 80% power, 45 students per group are required. Taking into account an expected attrition rate of 5% in the interventional group and 10% in the control group, the final size was increased to 97 students in total.

PRE-INTERVENTION. From week 1 to 2. All students will undergo a two-hour session, during which they will complete questionnaires on sedentary behavior and physical activity, stress, sleep and fatigue levels. Heart Rate Variability will be measured. Students will perform four physical fitness tests (vertical jump, maximal isometric strength, flexibility and endurance). Then, they will wear actimeters to record sleep, sedentary behaviors and physical activity levels during two weeks.

INTERVENTION. From week 3 to 14. The intervention program aims to address three key aspects of well-being. The students in the intervention group will take part in three modules, one on stress, one on sleep and fatigue, and the other on sedentary behaviors and physical activity.

The sequence of modules was established in the following order: stress module, sleep module, and physical activity module.

Each module will consist of three sessions, each lasting between 45 minutes and two hours, with approximately 10 days between each session.

To avoid too many intervention days, several sessions will be paired with another: The third stress session will be paired with the first sleep session, the second sleep session will be paired with the first physical activity session and the third sleep session will be paired with the second physical activity session.

Each session includes a period of pedagogical content delivered in small groups , as well as individual interviews between an expert and the participant (i.e.student). The sessions will be scheduled as follow:

* Session 1 Stress: Week 3 * Session 2 Stress: Week 5 * Session 3 Stress: Week 7 * Session 1 Sleep: Week 7 * Session 2 Sleep: Week 9 * Session 3 Sleep: Week 11 * Session 1 Physical activity: Week 9 * Session 2 Physical activity: Week 11 * Session 3 Physical activity: Week 13

During the interview, the expert will realize an initial assessment of student health behaviors and will give personalized goals to students. Subsequent sessions follow the same structure. Subjective and objective indicators related to each intervention domain will be recorded to assess the progress and the satsifaction of students.

POST-INTERVENTION. From week 15 to 16. All students will undergo the exact same set of measurements as described in pre-intervention.

• Academic self-efficacy. Change from the pre-intervention in score obtained at the General Academic Self-Efficacy Scale (GASE) at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Kessler Psychological Distress Scale (KPDS). Change from the pre-intervention in score obtained at the Kessler Psychological Distress Scale (KPDS) questionnaire to the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module. [Time frame: Week 7]
• Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module. [Time frame: Week 11]
• Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sedentary behaviors and physical activity module. [Time frame: Week 13]
• Perceived level of stress. Change from pre-intervention in score obtained at the Perceived Stress Scale (PSS) at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Multidimensional Fatigue. Change from the pre-intervention in score obtained at the Multidimensional Fatigue Inventory (MFI) at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Coping strategies. Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Perceived level of sleep troubles. Change from pre-intervention in score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI) at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]
• Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 16. [Time frame: Week 1 (Pre-intervention) and Week 16 (Post-intervention)]