NCT05974735

Brief Summary

Participants will be selected according to their affiliation with the Paris 8 CPTS. They will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. These tests will be used to define a wellness pathway for each participant in order to reduce the stress they feel at work. These wellness pathways are based around 4 distinct themes:

  • Diet, nutrition and micronutrition
  • Physical activity
  • Sleep
  • Stress and wellness. Participants will be follow-up at 3 and 6 months by means of self-questionnaires and advice on the programme.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 12, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

July 12, 2023

Last Update Submit

October 12, 2023

Conditions

Keywords

professionals and actors health

Outcome Measures

Primary Outcomes (1)

  • Evaluate the 3-month effectiveness of a well-being programme in improving stress management among healthcare professionals and workers with moderate stress.

    Changes in the Perceived Stress Scale (PSS) score at 3 months after the SMS setting up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.

    3 Months

Secondary Outcomes (4)

  • Evaluate the effectiveness of a well-being programme in improving stress management in healthcare professionals and workers with moderate stress at 6 months

    6 Months

  • Evaluate the effectiveness of a well-being programme in improving the lifestyle habits of healthcare professionals and workers at 3 and 6 months

    3 and 6 Months

  • Compare the effectiveness of a well-being programme in improving stress management among healthcare professionals and workers, depending on their job

    3 and 6 Months

  • Observe the acceptability to healthcare professionals and workers of setting up a well-being programme

    3 and 6 Months

Interventions

Wellness trailBEHAVIORAL

Setting up wellness trails based on four distinct themes: * Food, Nutrition and Micronutrition * Physical activity * Sleep * Stress and well-being

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health professionals and actors affiliated to the Communauté professionnelle territoriale de santé (CPTS) Paris 8.

You may qualify if:

  • People of legal age
  • Health professionals and players from the CPTS Paris 8 association:
  • Pharmacist,
  • Doctor
  • Midwife
  • Physiotherapist,
  • Dentist,
  • Nurse,
  • Pharmacy assistant,
  • Dietician-nutritionist,
  • Speech therapist,
  • Chiropodist,
  • Adapted physical activity teacher,
  • Medical secretary,
  • Other health service staff (maintenance, reception, general services and IT staff).
  • +2 more criteria

You may not qualify if:

  • People already following a wellness programme.
  • People undergoing treatment for stress prescribed by a doctor.
  • People on sick leave or long-term leave who are no longer at work and who cannot be included in the study.
  • People with a poor understanding of spoken and/or written French.
  • Vulnerable persons in accordance with article L1121-6 of the CSP.
  • Persons subject to a legal protection measure (guardianship, curatorship) or unable to express their consent/non-opposition in accordance with article L1121-8 of the CSP or under court protection in accordance with article L1122-2 of the CSP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPTS Paris 8

Paris, 75008, France

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Eric MYON

    CPTS Paris 8

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 3, 2023

Study Start

October 9, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations