Impact of a Physical Activity Program on the Mental Health of Medical Students.

NCT06822075 | Enrolling By Invitation

• 1 other identifier: SANTE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Behavior; Health Related Physical Fitness; Mental Health; Sedentary Behaviors; Physical Inactivity; Medical Student

Keywords

Health; Student; Curriculum; Behavior; Medical; Physical activity; Sedentary; Mental and physical health; Isolation; Loneliness

Outcome Measures

Primary Outcomes (1)

• Overall mental health : Evolution of the score obtained at the Depression Anxiety and Stress Scale-21 (DASS-21)

  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).

  Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)

Secondary Outcomes (14)

• 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)

Other Outcomes (1)

• Likert - Questionnaire of satisfaction

  Week 15-16 (Post-intervention)

Study Arms (2)

INT-1

EXPERIMENTAL

The group INT-1 will get SANTE Program during the first period of the study, then noting during the second period.

Behavioral: SANTE program

INT-2

EXPERIMENTAL

The group INT-2 will get noting during the first period of the study, then SANTE program during the second period.

Behavioral: SANTE program

Interventions

SANTE program BEHAVIORAL

The intervention will consist of distinct period. Fisrt, 3 complete assessment periods will be realized : pre-intervention (week 1-2) ; mid-intervention (week 8-9) ; post-intervention (week 15 - 16) for evaluate the evolution of the health-related behavior, mental and physical health. Second, the SANTE program intervention will be implemented. Intervention 1 (week 3 and 7) for INT-1 group receive the SANTE program and INT-2 group do noting ; Intervention 2 (week 10-14) for INT-2 group receive the SANTE program and INT-1 do noting. The SANTE intervention will consist of (at a minimum): * 1 to 2 group physical activity sessions per week * 1 outdoor outing (full-day or half-day) per month * 1 individual meeting with a physical activity and sports expert

INT-1; INT-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a 2th-year or a 3th-year medical student at the Faculty of Medicine Lyon East and Lyon South during the academic years 2024-2025.
• Having read the information note.
• Having signed the written consent.

Sponsors & Collaborators

• Research on Healthcare Performance Lab U1290: lead

Study Sites (1)

RESHAPE

Lyon, France, 69008, France

Location

MeSH Terms

Conditions

Health Behavior; Psychological Well-Being; Sedentary Behavior; Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Personal Satisfaction

Study Officials

• Sophie Schlatter, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know whether they are receiving the intervention first or second.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An interventional study (intervention = SANTE program) with a crossover protocol, preceded by an randomization (1:1). One group will get SANTE Program during the first period of the study, then noting during the second period. The other group will get noting during the first period of the study, then SANTE program during the second period. Both groups will successively benefit from the intervention (INT-1 group first, followed by the INT-2 group).

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 12, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

FR (1)