NCT03203135

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.).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

June 19, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2018

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

June 19, 2017

Last Update Submit

December 6, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Waist circumference

    in centimeters

    14 months

  • Weight

    in kg

    14 months

  • Blood pressure

    in mm Hg

    14 months

  • Metabolic parameters (Total cholesterol, HDL, LDL, Triglycerdies, glycemia)

    in g/l

    14 months

  • Food consumption behavior and food representations

    score

    14 months

  • Physical activity level

    Ricci and gagnon score

    14 months

  • Height

    in meters

    14 months

Secondary Outcomes (6)

  • Motivation to change habits

    14 months

  • Body Feeling

    14 months

  • Well-being

    14 months

  • Stress

    14 months

  • Sleep quality

    14 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL
Behavioral: Nutritional prevention programme

Control Group

NO INTERVENTION

Interventions

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.) .

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants working at CITEO in staggered hours

You may not qualify if:

  • Pregnant woman, person with severe pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Jean-Michel LECERF, MD

    IPL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 29, 2017

Study Start

June 20, 2017

Primary Completion

September 7, 2018

Study Completion

September 7, 2018

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations