Preventive Remediation for OptiMal StudentS (PROMESS-Group)

NCT07030751 | Enrolling By Invitation

• 1 other identifier: PROMESS-Group
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Health students exhibit excessive sedentary behavior, elevated stress levels, and significant sleep disturbances, all of which contribute to a decline in their overall health, quality of life, and learning capacities. The PROMESS-Group project (Preventive Remediation for OptiMal StudentS-Group) is a multimodal intervention targeting stress management, sleep improvement, and physical activity enhancement, with the aim of improving students' quality of life throughout their academic journey. 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 of health 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; 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 16.

  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: 1. Pre-intervention measure at week 1: before any involvement in the intervention (for the control and interventional groups). 2. Post-intervention measure at week 16 : after the intervention (for the control and interventional groups). * Change = (Week 16 score - Week 1 score) Evolution of the 4 subscores will also be analyzed independantly.

  Week 1 (Pre-intervention) and Week 16 (Post-intervention)

Secondary Outcomes (62)

• Academic self-efficacy. Change from the pre-intervention in score obtained at the General Academic Self-Efficacy Scale (GASE) at the post-interventional measure at Week 16.

  Week 1 (Pre-intervention) and Week 16 (Post-intervention)

• Kessler Psychological Distress Scale (KPDS). Change from the pre-intervention in score obtained at the Kessler Psychological Distress Scale (KPDS) questionnaire to the post-interventional measure at Week 16.

  Week 1 (Pre-intervention) and Week 16 (Post-intervention)

• Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module.

  Week 7

• Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module.

  Week 11

• Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sedentary behaviors and physical activity module.

  Week 13

Study Arms (2)

Intervention

EXPERIMENTAL

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

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

Control

NO INTERVENTION

Students in the control group will receive a specific 'compensatory' intervention after the post-intervention period

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 specific order (stress, sleep, physical activity). Each module will be composed of 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- or 5th-year medical student enrolled at the Faculty of Medicine (Lyon Est or Lyon Sud), or a PhD student registered in Lyon's health-related doctoral schools during the 2024-2025 or 2025-2026 academic years
• Having read the information note
• Having signed the written consent

You may not qualify if:

• Student who did not provide consent
• Non-French-speaking student

Sponsors & Collaborators

• Research on Healthcare Performance Lab U1290: lead

Study Sites (1)

Research on Healthcare Performance Lab U1290

Lyon, 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 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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial. Randomization into two groups: INTERVENTION group and CONTROL group (1:1). 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 sequence of modules was established in the following order: stress module, sleep module, and physical activity module. Students in the control group will receive a specific 'compensatory' intervention after the post-intervention period.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 16, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)