Clinical trial NCT06309771: Preventive Remediation for Optimal MEdical StudentS (PROMESS)
Official title: Influence of a Complex Behavioural Intervention on the Quality of Life of Medical Students: A Randomized, Controlled, Single-Center Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Health Behavior
Health-Related Behavior
Keywords: Health
Student
Curriculum
Behavior
Quality of life
Medical
Performance
Stress
Sleep
Fatigue
Sedentary behaviors
Physical Activity
Medical pedagogy
Lead sponsor: Research on Healthcare Performance Lab U1290
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial. Randomization into two groups: INTERVENTION group and CONTROL group. The INTERVENTION group will have the opportunity to follow a preventive remediation program based on 3 modules: stress management, sleep improvement and fatigue reduction, and sedentary behaviors reduction and physical activity promotion. The order of following the 3 modules will be randomized. The CONTROL group will not receive any intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Exclusion Criteria:

* No exclusion criteria will be applied.

Primary outcomes:
measure: Quality of life. Change from pre-intervention in a composite score obtained at the Brief Quality Of Life questionnaire at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
Secondary outcomes:
measure: Academic self-efficacy. Change from the pre-intervention in score obtained at the Academic self-efficacy questionnaire at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Wu self efficacy questionnaire. Change from pre-intervention in score obtained at the adapted Wu self efficacy questionnaire at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Academic performances. Scores and ranks obtained at all the official exams during the 2023-2024 academic year.
timeFrame: All along the project, in average 30 weeks.
measure: VAS - quality of life. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of Quality Of Life
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - self-confidence. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-confidence.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - self-efficacy. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-efficacy.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - resources. Evolution of the score obtained at the 100-mm Visual Analogue Scale assessing the perceived level of resources.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - work-life balances. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the work-life balances.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - stressors quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - stress coping. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - stress quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - sleep quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28
measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30
measure: VAS - physical fitness. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30.
measure: VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the level of physical activity.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30.
measure: VAS - sedentary behaviors. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviors.
timeFrame: Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30.
measure: Perceived level of stress. Change from pre-intervention in score obtained at the Perceived Stress Scale (PSS) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Coping strategies.Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Quantity of stressors. Score obtained at the Holmes and Rahe Questionnaire Inventory during the pre-intervention.
timeFrame: Week 1 (Pre-intervention).
measure: Big-5. Scores obtained at the Big-5 questionnaire.
timeFrame: Week 1 (Pre-intervention).
measure: 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 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Epworth Sleepiness scale. Change from the pre-intervention in score obtained at the Epworth Sleepiness scale at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Multidimensional Fatigue. Change from the pre-intervention in score obtained at the Multidimensional Fatigue Inventory (MFI) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS).
timeFrame: Week 1 (Pre-intervention)
measure: Perceived level of physical activity. Change from the pre-intervention in score obtained at the Global Physical Activity Questionnaire (GPAQ) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Perceived level of sedentary. Change from the pre-intervention in score obtained at the Rapid Physical Activity Questionnaire (RPAQ) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Heart rate variability (HRV) marker. Change from pre-intervention in cardiac coherence at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Heart rate variability (HRV) marker. Change from pre-intervention in the SDNN score in at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Heart rate variability (HRV) marker. Change from pre-intervention in the pnn50% score in at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Heart rate variability (HRV) markers.Change from pre-intervention in the Low frequency / High frequency ratio (LF/HF) ratio in at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Time in Bed at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Total Sleep duration at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Sleep efficiency at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Sleep Onset Latency at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Wake after Sleep Onset at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Number of Awakenings at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Mid-sleep point at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Bedtime at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Sleep Onset time at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Sleep Inertia at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Wake-up time at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Sleep regularity index at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Total activity at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in light physical activity at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Steps count at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in energy expenditure at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in sedentary breaks at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in prolonged sedentary bouts at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Actimetry records. Change from pre-intervention in vector of the dynamic body acceleration (VeDBA) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Physical fitness markers - Strength. Change from pre-intervention in the force developed during a maximal isometric contraction of the quadriceps at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Physical fitness markers - Power. Change from pre-intervention in height of jump at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Physical fitness markers - Power. Change from pre-intervention in time of flight at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Physical fitness markers - Power. Change from pre-intervention in relative power at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Physical fitness markers - Endurance. Change from pre-intervention in speed through the endurance test at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Physical fitness markers - Endurance. Change from pre-intervention in VO2max through the endurance test at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Physical fitness markers - Endurance. Change from pre-intervention in heart rate during the endurance test at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Body composition markers. Change from the pre-intervention in Body Mass Index (BMI) at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Body composition markers. Change from the pre-intervention in fat mass at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Body composition markers. Change from the pre-intervention in Skeletal muscle mass at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Body composition markers.Change from the pre-intervention in total body hydration at the post-interventional measure at Week 27.
timeFrame: Week 1 (Pre-intervention) and Week 27 (Post-intervention)
measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module.
timeFrame: Week 9,11,10 - 16,17,18 - 24,25,26
measure: 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.
timeFrame: Week 9,11,10 - 16,17,18 - 24,25,26
measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module.
timeFrame: Week 9,11,10 - 16,17,18 - 24,25,26
measure: Question recommendation. Answer to the question "Would you recommend a friend to participate at the PROMESS project?" asked during the post-intervention.
timeFrame: Week 27 (Post-intervention)
measure: Question Habits change. Answer to the question "Do you think that your participation at the PROMESS project has modified your health behaviors/actions?" asked during the post-intervention.
timeFrame: Week 27 (Post-intervention)
measure: Question Habits change. Answer to the question ""For which behaviors do you think you have modified your habits/actions?" asked during the post-intervention.
timeFrame: Week 27 (Post-intervention)
Other outcomes:
Locations:
city: Lyon
country: France
facility: RESHAPE
Study officials:
affiliation: RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
name: Sophie Schlatter, Dr.
role: PRINCIPAL_INVESTIGATOR
References: