Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-28 @ 8:30 PM
Study NCT ID:
NCT07030751
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-26
First Post:
2025-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Remediation for OptiMal StudentS (PROMESS-Group)
Sponsor:
Research on Healthcare Performance Lab U1290
Organization:
Study Overview
Official Title:
Interest Of a Group-Based and Multimodal Intervention on the Quality of Life of Healthcare Students: A Randomized, Controlled, Single-Center Study.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMESS-Group
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.
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 academic year, 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 population will consist of 60 health students, with 1/2 (n=30 students) assigned to the intervention group and 1/2 (n=30 students) to the control group.
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.
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 population will consist of 60 health students, with 1/2 (n=30 students) assigned to the intervention group and 1/2 (n=30 students) to the control group.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: