Preventive Remediation for Optimal MEdical StudentS (PROMESS)

NCT06309771 | Enrolling By Invitation

• 1 other identifier: PROMESS - QOL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Medical students are under a great deal of competitive pressure throughout their training. During their studies, medical students experience high levels of stress, sleep disorders and excessive physical inactivity. These feelings and behaviours are expected to significantly degrade their quality of life, health and performance. The PROMESS project aims to increase students' quality of life and ultimately improve their medical performance. The project aims to improve students' ability to take care of themselves from a short and long term perspective. Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future. The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life and academic performance of 2nd cycle medical students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers.

Conditions

Health Behavior; Health-Related Behavior

Keywords

Health; Student; Curriculum; Behavior; Quality of life; Medical; Performance; Stress; Sleep; Fatigue; Sedentary behaviors; Physical Activity; Medical pedagogy

Outcome Measures

Primary Outcomes (1)

• Quality of life. Change from pre-intervention in a composite score obtained at the Brief Quality Of Life questionnaire at the post-interventional measure at Week 27.

  The students level of the quality of life is assessed four sub-scores of quality of life (i.e. physical health, psychic well-being, social relationship, environnement). The composite score is the mean of the 2 dimensions: physical health and psychological well-being. The measure will be done at different time frame: * Pre-intervention measure at week 1: before any involvement in the intervention (for the control and interventional groups). * Post-intervention measure at week 27 : after the intervention (for the control and interventional groups). Change = (Week 27 score - Week 1 score)

  Week 1 (Pre-intervention) and Week 27 (Post-intervention)

Secondary Outcomes (71)

• Academic self-efficacy. Change from the pre-intervention in score obtained at the Academic self-efficacy questionnaire at the post-interventional measure at Week 27.

  Week 1 (Pre-intervention) and Week 27 (Post-intervention)

• Wu self efficacy questionnaire. Change from pre-intervention in score obtained at the adapted Wu self efficacy questionnaire at the post-interventional measure at Week 27.

  Week 1 (Pre-intervention) and Week 27 (Post-intervention)

• Academic performances. Scores and ranks obtained at all the official exams during the 2023-2024 academic year.

  All along the project, in average 30 weeks.

• VAS - quality of life. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of Quality Of Life

  Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30

• VAS - self-confidence. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-confidence.

  Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 30

Study Arms (2)

Intervention

EXPERIMENTAL

Complex behavioral intervention based on health-related modules.

Behavioral: Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion.

Control

NO INTERVENTION

Students from the control group will follow no modules.

Interventions

Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion. BEHAVIORAL

The study seeks to quantify the impact of a complex intervention based on 3 modules : 1. Stress management 2. Sleep improvement and fatigue reduction, 3. Sedentary behaviors reduction and physical activity promotion. Students from the interventional group will follow these 3 different health-related modules in a random order (6 predetermined order). Each module will be composed on 3 sessions. Each session includes individual interviews covering initial assessment and personalized goal setting.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• Research on Healthcare Performance Lab U1290: lead

Study Sites (1)

RESHAPE

Lyon, 69008, France

Location

MeSH Terms

Conditions

Health Behavior; Behavior; Fatigue; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: OUTCOMES ASSESSOR
• Masking Details: Assessors of pre and posttest measures will be blinded to the group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial. Randomization into two groups: INTERVENTION group and CONTROL group. The INTERVENTION group will have the opportunity to follow a preventive remediation program based on 3 modules: stress management, sleep improvement and fatigue reduction, and sedentary behaviors reduction and physical activity promotion. The order of following the 3 modules will be randomized. The CONTROL group will not receive any intervention.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: March 13, 2024
• Study Start: November 11, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)