protocolSection identificationModule nctId: NCT06309771, orgStudyIdInfo id: PROMESS - QOL, briefTitle: Preventive Remediation for Optimal MEdical StudentS (PROMESS), acronym: PROMESS, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Research on Healthcare Performance Lab U1290, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Health Behavior, conditions: Health-Related Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Assessors of pre and posttest measures will be blinded to the group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion., outcomesModule primaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Academic performances. Scores and ranks obtained at all the official exams during the 2023-2024 academic year., secondaryOutcomes 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, secondaryOutcomes measure: VAS - self-confidence. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-confidence., secondaryOutcomes measure: VAS - self-efficacy. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-efficacy., secondaryOutcomes measure: VAS - resources. Evolution of the score obtained at the 100-mm Visual Analogue Scale assessing the perceived level of resources., secondaryOutcomes measure: VAS - work-life balances. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the work-life balances., secondaryOutcomes measure: VAS - stressors quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors., secondaryOutcomes 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., secondaryOutcomes measure: VAS - stress coping. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations., secondaryOutcomes measure: VAS - stress quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress., secondaryOutcomes measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality., secondaryOutcomes measure: VAS - sleep quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep., secondaryOutcomes measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue., secondaryOutcomes measure: VAS - physical fitness. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness., secondaryOutcomes measure: VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the level of physical activity., secondaryOutcomes measure: VAS - sedentary behaviors. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviors., secondaryOutcomes 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., secondaryOutcomes measure: Coping strategies.Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 27., secondaryOutcomes measure: Quantity of stressors. Score obtained at the Holmes and Rahe Questionnaire Inventory during the pre-intervention., secondaryOutcomes measure: Big-5. Scores obtained at the Big-5 questionnaire., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS)., secondaryOutcomes 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., secondaryOutcomes 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., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in cardiac coherence at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in the SDNN score in at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in the pnn50% score in at the post-interventional measure at Week 27., secondaryOutcomes 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., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Time in Bed at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Total Sleep duration at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep efficiency at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep Onset Latency at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Wake after Sleep Onset at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Number of Awakenings at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Mid-sleep point at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Bedtime at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep Onset time at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep Inertia at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Wake-up time at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep regularity index at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Total activity at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in light physical activity at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Steps count at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in energy expenditure at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in sedentary breaks at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in prolonged sedentary bouts at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in vector of the dynamic body acceleration (VeDBA) at the post-interventional measure at Week 27., secondaryOutcomes 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., secondaryOutcomes measure: Physical fitness markers - Power. Change from pre-intervention in height of jump at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Power. Change from pre-intervention in time of flight at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Power. Change from pre-intervention in relative power at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Endurance. Change from pre-intervention in speed through the endurance test at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Endurance. Change from pre-intervention in VO2max through the endurance test at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Endurance. Change from pre-intervention in heart rate during the endurance test at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers. Change from the pre-intervention in Body Mass Index (BMI) at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers. Change from the pre-intervention in fat mass at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers. Change from the pre-intervention in Skeletal muscle mass at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers.Change from the pre-intervention in total body hydration at the post-interventional measure at Week 27., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module., secondaryOutcomes 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., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module., secondaryOutcomes measure: Question recommendation. Answer to the question "Would you recommend a friend to participate at the PROMESS project?" asked during the post-intervention., secondaryOutcomes 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., secondaryOutcomes 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., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RESHAPE, city: Lyon, zip: 69008, country: France, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False