Cardiovascular Risk Prevention Among Night Workers

NCT02899442 | Completed

• 2 other identifiers: RC31/14/73412015-A00895-44
• Study Type: interventional
• Target: 3,056
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Diseases

Keywords

cardiovascular risk; Occupational Health; night work; Public Health; Preventive Health Services

Outcome Measures

Primary Outcomes (1)

• Change of Metabolic Syndrome Factors

  Measure of Metabolic Syndrome Factors, Reduction of incidence of metabolic syndrome between the two groups (control and experimental) over 2 years' follow up. Metabolic syndrome defined as three or more among the following five criteria are present: 1) waist circumference (≥102 cm for male; ≥ 88 cm for female); 2) plasma triglycerides ≥ 1.7 mmol/l or treatment; 3) HDL cholesterol\<1.0 mmol/l for male and 1.3 mmol/l for female or treatment, 4) blood pressure ≥ 130/85 mmHg or treatment; 5) fasting glycaemia ≥ 5.5 mmol/l or treatment 35.

  inclusion (T0), and 24 months (T24)

Secondary Outcomes (1)

• Change of preventive interventions

  At inclusion (T0), and 24 months (T24)

Study Arms (2)

individual prevention

NO INTERVENTION

The individual preventive advice will be delivered to the control group by occupational physicians during routine medical examinations (defined by law, each 6 months), in occupational medical centres. The type and time spent to explain this advice will be collected in case report form. To ensure each night workers included in the control group received the same advice, a booklet was provided outlining the content under 5 main headings: 1. Information about health risks for night workers 2. Dietetic intake 3. Leisure physical activities 4. Sleep and alertness 5. Lifestyle behaviors (Tobacco, alcohol and psychoactive drugs consumption) That's a current practice in France for Occupational physicians.

individual and collective prevention

EXPERIMENTAL

In addition to this individual prevention, the night workers from the experimental group will benefit from implementation of preventive actions in the workplace (collective prevention in workplace ). These collective preventive measures will be dispensed by the occupational health team (occupational physicians and technician of occupational risks prevention).

Other: collective prevention in workplace

Interventions

collective prevention in workplace OTHER

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

individual and collective prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For occupational physicians (cluster level)
• Being volunteer
• Physician is responsible of the night workers' monitoring, in plants with at least 10 employees
• Working in multidisciplinary collaborations (occupational physicians and technician on prevention of occupational risks)
• Carrying out professional activities in the 4 referenced regions.
• Performing medical monitoring of night workers every 6 months in accordance with the legislation, as outlined previously.
• For night workers (subject level) night worker must work in a plant with at least 10 employees
• Have a permanent contract and a stable job during the next 2 years
• Be aged 18 years and older participate voluntarily and agree to sign a consent form

You may not qualify if:

• For occupational physicians (cluster level)
• Having planned giving up occupational activities during next 2 years
• For night workers: (subject level)
• Failing to speak and/ or understand French language
• Being pregnant

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• assistance of the French National Health Insurance Fund for Employees (CNAMTS): collaborator
• French Directorate General of Health (DGS): collaborator
• ARC Foundation for Cancer Research: collaborator
• National Cancer Institute, France: collaborator
• French National Institute for Prevention and Education in Health (INPES): collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• French Inter-Departemental Agency for the Fight against Drugs and Addictive Behaviors (Mildeca): collaborator
• French Social Security Scheme for Liberal Professionals (RSI): collaborator

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Workplace

Intervention Hierarchy (Ancestors)

Employment; Socioeconomic Factors; Population Characteristics; Personnel Management; Organization and Administration; Health Services Administration

Study Officials

• Yolande ESQUIROL, MDPhD

  esquirol.y@chu-toulouse.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 14, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

FR (1)