PREV'HODE: Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.

Sponsor

Institut Pasteur de Lille (Other)

Overall Status

Unknown status

CT.gov ID

NCT03203135

Collaborator

(none)

185

Enrollment

Location

Arms

21.3

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.).

Condition or Disease	Intervention/Treatment	Phase
Shift-work Eating Behavior	Behavioral: Nutritional prevention programme	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

185 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.

Actual Study Start Date :

Jun 20, 2017

Anticipated Primary Completion Date :

Sep 30, 2018

Anticipated Study Completion Date :

Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group	Behavioral: Nutritional prevention programme 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

Arm

Intervention/Treatment

Experimental: Intervention Group

Behavioral: Nutritional prevention programme

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

Outcome Measures

Primary Outcome Measures

Waist circumference [14 months]
in centimeters
Weight [14 months]
in kg
Blood pressure [14 months]
in mm Hg
Metabolic parameters (Total cholesterol, HDL, LDL, Triglycerdies, glycemia) [14 months]
in g/l
Food consumption behavior and food representations [14 months]
score
Physical activity level [14 months]
Ricci and gagnon score
Height [14 months]
in meters

Secondary Outcome Measures

Motivation to change habits [14 months]
scale of Prochaska
Body Feeling [14 months]
Analog visual scales (AVS)
Well-being [14 months]
AVS
Stress [14 months]
AVS
Sleep quality [14 months]
AVS
Fatigue [14 months]
scale of Pichot

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants working at CITEO in staggered hours

Exclusion Criteria:

Pregnant woman, person with severe pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NutrInvest - Institut Pasteur de Lille	Lille	Nord	France	59019

Sponsors and Collaborators

Institut Pasteur de Lille

Investigators

Principal Investigator: Jean-Michel LECERF, MD, IPL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean-Michel Lecerf, Professor, Institut Pasteur de Lille

ClinicalTrials.gov Identifier:

NCT03203135

Other Study ID Numbers:

2017-A00812-51

First Posted:

Jun 29, 2017

Last Update Posted:

Jun 29, 2017

Last Verified:

Jun 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 29, 2017