Preventive Remediation for Optimal MEdical StudentS (PROMESS)

NCT ID: NCT06309771

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2024-09-30

Brief Summary

Medical students are under a great deal of competitive pressure throughout their training. During their studies, medical students experience high levels of stress, sleep disorders and excessive physical inactivity. These feelings and behaviours are expected to significantly degrade their quality of life, health and performance.

The PROMESS project aims to increase students' quality of life and ultimately improve their medical performance. The project aims to improve students' ability to take care of themselves from a short and long term perspective.

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 and academic performance of 2nd cycle medical 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 future healthcare professionals 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, 4th and 5th-year students at the Faculty of Medicine of Lyon Est will have the opportunity to participate in the PROMESS project. Voluntary will be randomized into 2 arms (intervention and control). The control group will not receive any intervention. The intervention group will follow a preventive program based on three modules: sedentary behaviors reduction and physical activity promotion, stress management, and sleep improvement and fatigue reduction. This program will span 30 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, and performance in the interventional arm.

METHODS.

POPULATION. The population consists of 70 medical students, with 2/3 (n=45 students) assigned to the intervention group and 1/3 (n=25 students) to the control group.

PRE-INTERVENTION. From week 1 to 3. 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. Bioimpedance and Heart Rate Variability will be measure. Students will perform three physical fitness tests (vertical jump, maximal isometric strength, and endurance). Then, they will wear actimeters to record sleep, sedentary behaviors and physical activity levels during three weeks.

INTERVENTION. From week 5 to week 25. 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 order of the 3 modules will be randomized so that each student will perform a specific module during one phase (e.g., a student will undergo the sleep module during the first phase, the stress module during the second phase, and the physical activity module during the third phase). Each module will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. Each session includes individual interview between an expert and the participant (i.e.student). The sessions will be scheduled as follow:

• First phase: week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3).
• Second phase: week 12 and 13 (session 1), week 14 and 15 (session 2), week 16, 17, and 18 (session 3).
• Third phase: week 19 and 20 (session 1), week 21 and 22 (session 2), week 23, 24, and 25 (session 3).

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

DURING THE INTERVENTION. Week 1,4,7,10,13,16,19,22,25,28,30. Evolutionary monitoring with multi-dimensional Visual Analogues Scales (quality of life, stress, fatigue, sleep, sedentary behaviors, physical activity) for intervention and control groups.

POST-INTERVENTION. From week 27 to 29. 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: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention

Complex behavioral intervention based on health-related modules.

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 random order (6 predetermined order). Each module will be composed on 3 sessions. Each session includes individual interviews covering initial assessment and personalized goal setting.

Control

Students from the control group will follow no modules.

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 random order (6 predetermined order). Each module will be composed on 3 sessions. Each session includes individual interviews covering initial assessment and personalized goal setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024.
• Having read the information note.
• Having signed the written consent.

• 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

Principal Investigators

Sophie Schlatter, Dr.

Role: PRINCIPAL_INVESTIGATOR

RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.

Locations

RESHAPE

Lyon, , France

Countries

France

Other Identifiers

PROMESS - QOL

Identifier Type: -

Identifier Source: org_study_id