Health BehaviorSANTENCT06822075
Impact of a Physical Activity Program on the Mental Health of Medical Students.
A study testing SANTE program in people with Health Behavior and Health Related Physical Fitness, run by Research on Healthcare Performance Lab U1290 at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health Related Physical Fitness, Mental Health
- What is being tested?
- SANTE program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SANTE - Solidarité, Activités Sportives et Ludiques, Nouveauté, Tissu et Étudiants
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
- Being tested
- SANTE program
- Keywords
- Health, Student, Curriculum, Behavior, Medical, Physical activity, Sedentary, Mental and physical health, Isolation, Loneliness
- Medical subject headings
- Health Behavior, Psychological Well-Being, Sedentary Behavior, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANTE programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| INT-1 | Experimental | The group INT-1 will get SANTE Program during the first period of the study, then noting during the second period. Receives: 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. Receives: Behavioral: SANTE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
The students level of physical activity and sedentary will be assessed through the Onaps-PAQ (National Observatory for Physical Activity and Sedentariness - Physical Activity Questionnaires) during a typical week. Scores are expressed in hours per day for week and weekend days. This measure will be done during the 3 complete assessment periods : pre-intervention (week 1-2) ; mid-intervention (week 8-9) ; post-intervention (week 15 - 16).
Measured: 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
The students level of well-being will be assessed through the WHO-5 WELL-BEING index. The total score is ranging from zero (worst possible mental well-being) to 100 (best possible mental well-being).
This 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).
Measured: 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)
The student's level of stress will be assessed through the PSS questionnaire ranging from 0 (none) to 40 (extreme).This 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).
Measured: 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.
The students level of loneliness will be assessed through the UCLA Loneliness Scale ranging from 20 (low) to 80 (extreme). This 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).
Measured: 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)
The students level of sleep disturbance will be assessed through the Pittsburgh Sleep Quality Index (PSQI) ranging from 0 (none) to 21 (extreme). This 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).
Measured: 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)
The student's level of fatigue will be assessed through the MFI questionnaire that covers various dimensions of fatigue, including general fatigue (9 to 45), mental fatigue (6 to 30), reduced motivation (2 to 10), and reduced activity (3 to 15). The higher the score, the greater the fatigue. This 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).
Measured: 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
Participants' habits and beliefs about physical activity will be assessed through this 9-item questionnaire, with responses ranging from 1 (strongly agree) to 5 (strongly disagree). This 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).
Measured: 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.
The students basal level of physical fitness will be assessed through a muscular strength test. This 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).
Measured: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers markers - Power. Height of jump.
The students basal level of physical fitness will be assessed through a power test, a vertical jump. The squat jump is plyometric exercise in which a person bends their knees to lower their body into a squat position, then performs an explosive jump upwards by extending the hips, knees, and ankles simultaneously. During this exercise, the height of jump will be measured.This 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).
Measured: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers markers - Power. Height of jump.
The students level of physical fitness will be assessed through a power test, a vertical jump. The squat jump is plyometric exercise in which a person bends their knees to lower their body into a squat position, then performs an explosive jump upwards by extending the hips, knees, and ankles simultaneously. During this exercise, the height of jump will be measured.
Measured: 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.
The students level of physical fitness will be assessed through cardiorespiratory endurance test (modified VAMEVAL). During this test, the velocity at maximal aerobic (VMA) is the maximum speed (velocity) reached where the individual can still maintain aerobic metabolism without transitioning into anaerobic metabolism. VO2max refers to the maximum rate of oxygen consumption during intense exercise, typically measured in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). It is a key indicator of an individual's cardiovascular fitness and aerobic endurance.
Measured: 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.
The students level of physical fitness will be assessed through a cardiorespiratory endurance test (modified VAMEVAL). The heart rate will be measured at three moments: maximum, submaximal, at 1 minute, and 3 minutes of recovery.
Measured: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers - Flexibility. Lower body
The students level of flexibility of lower body will be assessed through the sit and reach test.
Measured: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers - Flexibility. Upper body
The students level of flexibility will be assessed through a upper body test.
Measured: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start6 Feb 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research on Healthcare Performance Lab U1290
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Schlatter, Dr., Principal investigator, RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822075
- Sponsor's protocol ID
- SANTE
- Acronym
- SANTE
- Status last verified
- Jun 2025
- First submitted
- 5 Feb 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SANTE - Solidarité, Activités Sportives et Ludiques, Nouveauté, Tissu et Étudiants
- ClinicalTrials.gov ID
- NCT06822075
- Acronym / sponsor ID
- SANTE / SANTE
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Research on Healthcare Performance Lab U1290University, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| INT-1 | Experimental | Behavioral: SANTE programThe group INT-1 will get SANTE Program during the first period of the study, then noting during the second period. |
| INT-2 | Experimental | Behavioral: SANTE programThe group INT-2 will get noting during the first period of the study, then SANTE program during the second period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria will be applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SANTE programThe 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 | Behavioural | INT-1, INT-2 |
Primary outcome
Overall mental health : Evolution of the score obtained at the Depression Anxiety and Stress Scale-21 (DASS-21)
Time frame: 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).
14 secondary outcomes
Perceived level of physical activity : Score obtained at the Onaps-PAQ on physical activity levels.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers markers - Power. Height of jump.
Time frame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers markers - Power. Height of jump.
Time frame: 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.
Time frame: 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.
Time frame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers - Flexibility. Lower body
Time frame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Physical Fitness markers - Flexibility. Upper body
Time frame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Schlatter, Dr. principal investigator
RESHAPE U1290 INSERM UCBL-LYON 1 Rockfeller, Lyon France.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SANTE program in people with Health Behavior and Health Related Physical Fitness, run by Research on Healthcare Performance Lab U1290 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mental health : Evolution of the score obtained at the Depression Anxiety and Stress Scale-21 (DASS-21) (time frame: Week 1 and 2 (pre-intervention) Week 8-9 (mid-intervention) Week 15-16 (Post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.