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

NCT ID: NCT06822075

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

INT-1

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

Group Type: EXPERIMENTAL

SANTE program

Intervention Type: 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-2

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

Group Type: EXPERIMENTAL

SANTE program

Intervention Type: 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

Interventions

SANTE program

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research on Healthcare Performance Lab U1290

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Schlatter, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

RESHAPE

Lyon, France, France

Countries

France

Other Identifiers

SANTE

Identifier Type: -

Identifier Source: org_study_id