- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203135
Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours. (PREV'HODE)
Staggered work affects about 20% of French employees and its health risks are now well known. They concern physical health (sleep disorders, weight gain, cancer, cardiovascular disorders, nutritional problems, etc.) and psychological health. Faced with these "alarming" findings, it is necessary to find ways of improvement and levers of action to prevent them.
This project aims to set up and evaluate a nutritional health prevention programme for the benefit of employees in staggered hours from CITEO. CITEO is a company of social mediation.
The objectives of the project are twofold: to evaluate the impact of working conditions in shifted schedules on food behavior and on to improve their eating behaviors.
How? Focusing on the pleasure of eating through a nutritional prevention program in which various and varied actions will be proposed but always adapted to the life of the company (example: culinary demonstration, physical activity, provision of baskets of Fruits, etc.).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nord
-
Lille, Nord, France, 59019
- NutrInvest - Institut Pasteur de Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants working at CITEO in staggered hours
Exclusion Criteria:
- Pregnant woman, person with severe pathology
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
|
The nutritional prevention programme will offer a wide range of food and physical activity activities adapted to the life of the company (example: culinary demonstration, physical activity, provision of fruit baskets, etc.) .
|
No Intervention: Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist circumference
Time Frame: 14 months
|
in centimeters
|
14 months
|
Weight
Time Frame: 14 months
|
in kg
|
14 months
|
Blood pressure
Time Frame: 14 months
|
in mm Hg
|
14 months
|
Metabolic parameters (Total cholesterol, HDL, LDL, Triglycerdies, glycemia)
Time Frame: 14 months
|
in g/l
|
14 months
|
Food consumption behavior and food representations
Time Frame: 14 months
|
score
|
14 months
|
Physical activity level
Time Frame: 14 months
|
Ricci and gagnon score
|
14 months
|
Height
Time Frame: 14 months
|
in meters
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation to change habits
Time Frame: 14 months
|
scale of Prochaska
|
14 months
|
Body Feeling
Time Frame: 14 months
|
Analog visual scales (AVS)
|
14 months
|
Well-being
Time Frame: 14 months
|
AVS
|
14 months
|
Stress
Time Frame: 14 months
|
AVS
|
14 months
|
Sleep quality
Time Frame: 14 months
|
AVS
|
14 months
|
Fatigue
Time Frame: 14 months
|
scale of Pichot
|
14 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Michel LECERF, MD, IPL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-A00812-51
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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