NCT06297304

Brief Summary

Medical students are under great competitive pressure throughout their studies. Our field surveys conducted in 2022 and 2023 at the Lyon Est Faculty of Medicine revealed that 78% of 482 students showed an excessive sedentary lifestyle compared to the threshold set by WHO. It is expected that a low level of physical activity and/or too high a sedentary lifestyle deteriorates significantly their quality of life and their health. In 2014, a British survey of 356 students in Medicine showed that lack of physical activity was an major predictor of burnout symptoms. Numerous studies show that regular physical activity improves the mental health of students and their cognitive performance. The PROMESS - PHYSICAL ACTIVITY project aims to offer solutions to students to decrease their sedentary behavior and to improve their physical activity level during their medical studies through an intervention program. From a long term perspective, this intervention may also prevent disorders related to inadequate levels of physical activity and/or sedentary behavior. It responds to a demand expressed by students : our previous field study showed that 45% of fourth-year students declared being "very interested and/or interested" in following an intervention that aimed at improving physical activity. The objective of this study is to determine the influence of an intervention based on sedentary behavior reduction and physical activity promotion among medical students.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

February 29, 2024

Last Update Submit

March 7, 2024

Conditions

Keywords

HealthStudentCurriculumBehaviourMedicalPhysical activitySedentary

Outcome Measures

Primary Outcomes (1)

  • Perceived level of sedentary : Evolution of the score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors.

    The students level of sedentary behaviors will be assessed through the RPAQ questionnaire.This questionnaire includes questions about sedentary behaviors, such as time spent sitting down.Scores are expressed in hours per day for week and weekend days. The measure will be done every session, i.e. session 1 (week 5-6), session 2 (week 7-8) and session 3 (week 9,10,11).

    From week 5 to week 11.

Secondary Outcomes (44)

  • Perceived level of physical activity : Score obtained at the Global Physical Activity Questionnaire (GPAQ) on physical activity levels.

    Week 1 (Pre-intervention)

  • Perceived level of sedentary : Score obtained at the Rapid Physical Activity Questionnaire (RPAQ) on sedentary behaviors.

    Week 1 (Pre-intervention)

  • Actimetry records.Total activity during the pre-intervention.

    From week 1 to week 3 (pre-intervention).

  • Actimetry records. Moderate-to-vigorous Physical Activity (MVPA) during the pre-intervention.

    From week 1 to week 3 (pre-intervention).

  • Actimetry records. Light Physical Activity during the pre-intervention.

    From week 1 to week 3 (pre-intervention).

  • +39 more secondary outcomes

Study Arms (1)

Physical Activity Intervention

EXPERIMENTAL

One arm : all volunteers will receive an intervention program based on sedentary behavior reduction and physical activity promotion.

Behavioral: Sedentary and physical activity behaviors

Interventions

The intervention will consist of three individual sessions, each lasting one hour, with approximately 15 days between each session. The sessions will be scheduled as follow: Week 5 and 6 (session 1), week 7 and 8 (session 2), week 9, 10, and 11 (session 3). During these sessions, subjective and objective indicators related to sedentary behaviors and the physical activity levels will be recorded to assess the progress of each student.

Physical Activity Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a 4th-year or a 5th-year medical student at the Faculty of Medicine Lyon East during the academic year 2023-2024.
  • Having read the information note.
  • Having signed the written consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RESHAPE

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Health BehaviorSedentary BehaviorBehaviorMotor Activity

Study Officials

  • Sophie Schlatter, Dr.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: All volunteers will receive a physical activity and sedentary management intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 7, 2024

Study Start

November 11, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations