Interest Of a Group-Based and Multimodal Intervention on the Quality of Life of Healthcare Students: A Randomized, Controlled, Single-Center Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- 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 16.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors of pre and posttest measures will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Student who did not provide consent
- •Non-French-speaking student
研究组 & 干预措施
Intervention
Interventions:
Behavioral: Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion.
干预措施: Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion. (Behavioral)
Control
Students in the control group will receive a specific 'compensatory' intervention after the post-intervention period
结局指标
主要结局
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 16.
时间窗: Week 1 (Pre-intervention) and Week 16 (Post-intervention)
The students level of the quality of life is assessed four sub-scores of quality of life (i.e. physical health, psychic well-being, social relationship, environnement). The composite score is the mean of the 2 dimensions: physical health and psychological well-being. The measure will be done at different time frame: 1. Pre-intervention measure at week 1: before any involvement in the intervention (for the control and interventional groups). 2. Post-intervention measure at week 16 : after the intervention (for the control and interventional groups). * Change = (Week 16 score - Week 1 score) Evolution of the 4 subscores will also be analyzed independantly.
次要结局
- Academic self-efficacy. Change from the pre-intervention in score obtained at the General Academic Self-Efficacy Scale (GASE) at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Perceived level of stress. Change from pre-intervention in score obtained at the Perceived Stress Scale (PSS) at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Kessler Psychological Distress Scale (KPDS). Change from the pre-intervention in score obtained at the Kessler Psychological Distress Scale (KPDS) questionnaire to the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module.(Week 7)
- Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module.(Week 11)
- 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.(Week 13)
- Multidimensional Fatigue. Change from the pre-intervention in score obtained at the Multidimensional Fatigue Inventory (MFI) at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- VAS - stress quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress.(Week 3, 5, 7)
- Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Coping strategies. Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- 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 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Sleep regularity index at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Physical fitness markers - Endurance. Change from pre-intervention in VO2max through the endurance test at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- VAS - sedentary behaviors. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviors.(Week 9, 11, 13)
- VAS - stressors quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors.(Week 3, 5, 7)
- 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.(Week 3, 5, 7)
- VAS - stress coping. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations.(Week 3, 5, 7)
- VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality.(Week 7, 9, 11)
- Perceived level of physical activity and sedentary. Change from the pre-intervention in score obtained at the Onaps-PAQ questionnaire to the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Loneliness scale (ESUL). Change from the pre-intervention in score obtained at the Loneliness scale (ESUL) to the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- VAS - sleep quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep.(Week 7, 9, 11)
- VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue.(Week 7, 9, 11)
- Actimetry records. Change from pre-intervention in Number of Awakenings at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Mid-sleep point at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- VAS - physical fitness. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness.(Week 9, 11, 13)
- VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the level of physical activity.(Week 9, 11, 13)
- Epworth Sleepiness scale. Change from the pre-intervention in score obtained at the Epworth Sleepiness scale at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Perceived level of physical activity. Change from the pre-intervention in score obtained at the Rapid Assessment of Physical Activity (RAPA) questionnaire to the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- ASSIST-Lite (Alcohol, Smoking and Substance Involvement Screening Tool - Lite). Change from the pre-intervention in score obtained at the ASSIST-Lite (Alcohol, Smoking and Substance Involvement Screening Tool-Lite) questionnaire to the post-intervention(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Heart rate variability (HRV) marker. Change from pre-intervention in cardiac coherence at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Heart rate variability (HRV) marker. Change from pre-intervention in the SDNN score at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Heart rate variability (HRV) marker. Change from pre-intervention in the pnn50% score in at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- 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 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Time in Bed at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Total Sleep duration at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Sleep efficiency at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Sleep Onset Latency at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Wake after Sleep Onset at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Sleep Inertia at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Bedtime at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Sleep Onset time at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in light physical activity at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in Wake-up time at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in sedentary breaks at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Physical fitness markers - Power. Change from pre-intervention in height of jump at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Actimetry records. Change from pre-intervention in prolonged sedentary bouts at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- 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 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Physical fitness markers - Power. Change from pre-intervention in time of flight at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Physical fitness markers - Power. Change from pre-intervention in relative power at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Physical fitness markers - Endurance. Change from pre-intervention in speed through the endurance test at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Physical fitness markers - Endurance. Change from pre-intervention in heart rate during the endurance test at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Physical fitness markers - Flexibility. Change from pre-intervention in flexibility at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Body composition markers. Change from the pre-intervention in Body Mass Index (BMI) at the post-interventional measure at Week 16.(Week 1 (Pre-intervention) and Week 16 (Post-intervention))
- Question recommendation. Answer to the question "Would you recommend a friend to participate in the PROMESS-group project?" asked during the post-intervention.(Week 16 (Post-intervention))
- Question change of habits. Answer to the question "Do you think that your participation in the PROMESS-group project has modified your health behaviors/actions?" asked during the post-intervention.(Week 16 (Post-intervention))
- Question change of habits. Answer to the question ""For which behaviors do you think you have modified your habits/actions?" asked during the post-intervention.(Week 16 (Post-intervention))
- Quantity of stressors. Score obtained at the Holmes and Rahe Questionnaire Inventory during the pre-intervention.(Week 1 (Pre-intervention))
- Big-5. Scores obtained at the Big-5 questionnaire.(Week 1 (Pre-intervention))
- Composite Scale of Morningness. Score obtained at the Composite Scale of Morningness (CSM).(Week 1 (Pre-intervention))