The Benefits of Dietary and Micro-nutritional Management for Well-being at Work

NCT06137898 | Unknown

• 1 other identifier: PIL-RIPH3-MEDEIS-023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to describe the benefits of this treatment, particularly in terms of changes in the well-being of participating employees in relation to their nutritional/micro-nutritional status.

Conditions

Well-Being, Psychological

Outcome Measures

Primary Outcomes (1)

• Evolution of WHO-5

  Evolution of World Health Organization Well-Being Index score (WHO 5) between M0 inclusion (V1) and 6 months after the start of management (V3).

  Baseline, 6 months

Secondary Outcomes (6)

• Evolution of subjective well-being

  Each month up to 12 months

• Evolution of psychological stress

  Each month up to 12 months

• Evolution of biological parameters

  Baseline, Month 3, Month 6, Month 12

• Prevention and evolution of symptomatologies mainly linked to nutritional nutritional/micro-nutritional status

  Baseline, Month 3, Month 6, Month 12

• Describe compliance with hygienodietary and micro-nutritional follow-up.

  Baseline, Month 3, Month 6, Month 12

Interventions

biological check-up BIOLOGICAL

Blood sampling

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult wishing to initiate dietetic and micro-nutritional management of their state of health

You may qualify if:

• Wishing to initiate dietetic and micro-nutritional management of their state of health
• Having freely declared to the investigator that he/she does not object to his/her participation in the study the study and to the collection of data strictly necessary for the study, after having received informed oral and written information from the investigator
• Have a smartphone compatible with the secure data collection application

You may not qualify if:

• Pregnant or breast-feeding women
• Person under court protection

Sponsors & Collaborators

• Larena SAS: lead

Study Sites (1)

CEN

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Carole PERRIN

  CEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samira AIT ABDELLAH

CONTACT

+33(0)1 45 51 78 77; s.aitabdellah@pileje.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: January 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)