Preventive Remediation for OptiMal StudentS (PROMESS-Group)

NCT ID: NCT07030751

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2026-07-16

Brief Summary

Health students exhibit excessive sedentary behavior, elevated stress levels, and significant sleep disturbances, all of which contribute to a decline in their overall health, quality of life, and learning capacities.

The PROMESS-Group project (Preventive Remediation for OptiMal StudentS-Group) is a multimodal intervention targeting stress management, sleep improvement, and physical activity enhancement, with the aim of improving students' quality of life throughout their academic journey.

Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future.

The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life of health students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers.

Detailed Description

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.

Conditions

Health Behavior; Health-Related Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Interventions:

Behavioral: Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion.

Group Type: EXPERIMENTAL

Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion.

Intervention Type: BEHAVIORAL

The study seeks to quantify the impact of a complex intervention based on 3 modules :

1. Stress management

2. Sleep improvement and fatigue reduction,

3. Sedentary behaviors reduction and physical activity promotion.

Students from the interventional group will follow these 3 different health-related modules in a specific order (stress, sleep, physical activity). Each module will be composed of 3 sessions. Each session includes individual interviews covering initial assessment and personalized goal setting.

Control

Students in the control group will receive a specific 'compensatory' intervention after the post-intervention period

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion.

The study seeks to quantify the impact of a complex intervention based on 3 modules :

1. Stress management

2. Sleep improvement and fatigue reduction,

3. Sedentary behaviors reduction and physical activity promotion.

Students from the interventional group will follow these 3 different health-related modules in a specific order (stress, sleep, physical activity). Each module will be composed of 3 sessions. Each session includes individual interviews covering initial assessment and personalized goal setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being a 4th- or 5th-year medical student enrolled at the Faculty of Medicine (Lyon Est or Lyon Sud), or a PhD student registered in Lyon's health-related doctoral schools during the 2024-2025 or 2025-2026 academic years
• Having read the information note
• Having signed the written consent

Exclusion Criteria

• Student who did not provide consent
• Non-French-speaking student

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research on Healthcare Performance Lab U1290

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research on Healthcare Performance Lab U1290

Lyon, , France

Countries

France

Other Identifiers

PROMESS-Group

Identifier Type: -

Identifier Source: org_study_id