SANTE - Solidarité, Activités Sportives et Ludiques, Nouveauté, Tissu et Étudiants
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall mental health : Evolution of the score obtained at the Depression Anxiety and Stress Scale-21 (DASS-21)
研究概览
简要总结
University students frequently adopt a sedentary lifestyle with low levels of physical activity, leading to a deterioration in their health. A significant number of them also suffer from social isolation. Moreover, numerous studies have highlighted the vulnerability of university students (particularly those in medical programs) to mental health issues. Medical students, with their demanding academic curriculum, are no exception to this trend.
A student association at the Lyon Est Faculty of Medicine reported that students' mental health is very low (2022): at least 1 in 2 students has experienced a depressive episode, and 1 in 3 has had suicidal thoughts during their studies. Other recent studies indicate that medical students at Lyon Est exhibit high levels of stress, low self-confidence, and excessive sedentary behavior (ECOSTRESS and ECOSPERF studies, 2021, 2022, and 2023). Unfortunately, in 2024, new mental health surveys among medical students from the second year through the end of their internship continue to confirm these findings.
The SANTE project aims to offer solution to student to a highly effective means of improving both their mental health and their level of physical activity throught an intervention program. More precisely, the goal of this interventional study is to evaluate the impact of a physical activity program on the mental health in second-cycle medical students at the University of Lyon 1. The development of the SANTÉ program was based on (i) data from the literature, (ii) results from a previous local study (IRB No. 2024-07-02-03) that identified student needs through individual interviews and focus groups, and (iii) local findings from a co-construction workshop with students.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participants will not know whether they are receiving the intervention first or second.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a 2th-year or a 3th-year medical student at the Faculty of Medicine Lyon East and Lyon South during the academic years 2024-
- •Having read the information note.
- •Having signed the written consent.
排除标准
- •No exclusion criteria will be applied.
研究组 & 干预措施
INT-2
The group INT-2 will get noting during the first period of the study, then SANTE program during the second period.
干预措施: SANTE program (Behavioral)
INT-1
The group INT-1 will get SANTE Program during the first period of the study, then noting during the second period.
干预措施: SANTE program (Behavioral)
结局指标
主要结局
Overall mental health : Evolution of the score obtained at the Depression Anxiety and Stress Scale-21 (DASS-21)
时间窗: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
The students level of overall mental health will be assessed through the DASS-21 questionnaire. A total score can also be assessed ranging from 0 (normal) to 63 (extremely severe). A score for the three subscales (depression, anxiety, stress) can also be assessed, each score ranging from 0 (normal) to 21 (extremely severe). The measure will be done during the 3 complete complete assessment periods : pre-intervention (week 1-2) ; mid-intervention (week 8-9) ; post-intervention (week 15 - 16).
次要结局
- Physical Fitness markers markers - Power. Height of jump.(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Perceived level of physical activity : Score obtained at the Onaps-PAQ on physical activity levels.(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Perceived level of well-being : Score obtained at The World Health Organization-Five (WHO-5) Well-Being Index(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Perceived level of stress : Score obtained at the Perceveid Stress Scale (PSS)(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Perceived level of loneliness : Score obtained at the UCLA Loneliness Scale.(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Perceived level of sleep disturbance : Score obtained at the Pittsburgh Sleep Quality Index (PSQI)(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Perceived level of fatigue : Score obtained at the Multidimentional Fatigue Inventory (MFI)(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Habits and beliefs about physical activity : Scores obtained at the Habits and Beliefs About Physical Activity Questionnaire(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Physical Fitness markers - Strength. The force developed during a maximal isometric contraction of the quadriceps.(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Physical Fitness markers - Endurance. Speed through the endurance test.(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Physical Fitness markers - Endurance. Heart rate during the endurance test.(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Physical Fitness markers - Flexibility. Lower body(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))
- Physical Fitness markers - Flexibility. Upper body(Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention))