Cardiovascular Risk Prevention Among Night Workers

NCT02899442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3056

Last updated 2024-03-22

No results posted yet for this study

Summary

With around 15 to 20% of workforce engaging in nightshift work in modern society for obvious economic and social reasons, the consequences of night work on cardiovascular risks are substantial. Compared to day workers, it was reported higher risks of cardiovascular diseases (estimated at 40%) and of metabolic syndrome (1.5 times) in shift workers. The occurrence of metabolic syndrome increases the risk to develop high blood pressure, diabetes and cardiovascular events. Because some characteristics of night work are potentially modifiable, some preventive strategies could be applied to reduce its adverse effects. For shift workers, some recent guidelines (High Health Authority, 2012 \& 2016) and fruitful literature propose to develop regular assessments of cardiovascular risk factors and occupational activities, and stress the need to expand preventive strategies. Moreover, some recent French laws provide an opportunity to implement preventive interventions and specific monitoring through the occupational physicians network. However, whether the concept is defined, the exact content, method and the potential benefits are unknown. The investigator assume that individual advice related to collective countermeasures referenced on guidelines (applied on worksite within plant) could lead a better improvement on incidence of metabolic syndrome compared to those that benefit only individual advice.

Main objective:

To measure the benefit from implementation of individual and collective prevention (dispensed in worksites within plants) on metabolic syndrome compared to strategy relying only on individual prevention among night workers, over 2 years' follow-up. The secondary objectives of the study are to evaluate in both groups:

1. Observance of different types of preventive strategies
2. Impact of observance of preventive advice on metabolic syndrome in shift workers and on each component of metabolic syndrome
3. Determinants which promote the up-take of preventive strategies among night workers
4. The countermeasures which could be applied and effective within company 5) Medico-economic assessment is planned from an ancillary study.

Conditions

Interventions

OTHER

collective prevention in workplace

From countermeasures referenced in guidelines, some tools were also created by the committee to standardize all preventive actions and to define measurable indicators. A specific monitoring for checking their applicability and for evaluating the duration of implementation is planned.Collective actions are classified in 7 categories:1)Standardized information of night work risk on health and countermeasure to prevent them, 2)Acknowledgement of the existence of the risk, thereby helping to raise general awareness, 3)Improvement of characteristics of night work (rhythm, rest, time to start and to end, schedule forecasted, duration of night work),4)Improvement of related conditions at night work (Job strain, monotonous or repetitive tasks, manager's help, collective co-operation; Light environment; Occupational physical activities, 5)Sleep improvements ,6)Improvement of dietetic intakes at work, 7)Improvement of leisure physical activity's practice within the work site

Sponsors & Collaborators

  • assistance of the French National Health Insurance Fund for Employees (CNAMTS)

    collaborator UNKNOWN
  • French Directorate General of Health (DGS)

    collaborator UNKNOWN
  • ARC Foundation for Cancer Research

    collaborator OTHER
  • National Cancer Institute, France

    collaborator OTHER_GOV
  • French National Institute for Prevention and Education in Health (INPES)

    collaborator UNKNOWN
  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • French Inter-Departemental Agency for the Fight against Drugs and Addictive Behaviors (Mildeca)

    collaborator UNKNOWN
  • French Social Security Scheme for Liberal Professionals (RSI)

    collaborator UNKNOWN
  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02899442 on ClinicalTrials.gov