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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00895-44 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| assistance of the French National Health Insurance Fund for Employees (CNAMTS) | UNKNOWN |
| French Directorate General of Health (DGS) | UNKNOWN |
| ARC Foundation for Cancer Research | OTHER |
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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:
Among the various causes of mortality, deaths attributable to cardiovascular diseases (CVD) are the most widespread worldwide. Despite major progress being made, the risk remains. Occupational factors such as shift work have emerged as potential CV risk factors. With around 15 to 20% of workforce engaging in nightshift work in modern society for obvious economic and social reasons, the consequences of which on occupational and social inequalities 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) 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.
Descriptive analysis according to the clusters and also to the both groups will be provided. Multivariate analysis, according to specific design of study (clusters), will be performed by multilevel analysis or marginal analysis. Given the specificity of self-employed people belonging to 'Regime social des independents, a target population will be added. The medical monitoring and individual prevention will be carried out by occupational physicians from occupational disease centres.
• Expected results From implementation of preventive strategies, investigator will expect: 1) The health improvement among night workers by decreased incidence of metabolic syndrome; by improved quality of life; 2) A improvement of social and professional development of night workers by a better tolerance of night work, and job retention; 3) Behavioral improvement by a positive impact of individual and collective behavioral changes on cardiovascular risks; 4) Practical actions by identifying factors which influence the implementation of preventive actions; 5) By this project, investigator would like also to determine some relevant, practical and effective actions which could be generalized at all night workers in preventive health public Policy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of preventive interventions | the rate of number of countermeasures needed at baseline by calculated number of countermeasures applied at the end of study; the frequency of countermeasures applied. | At inclusion (T0), and 24 months (T24) |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
1) Main Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yolande ESQUIROL, MDPhD | esquirol.y@chu-toulouse.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toulouse University Hospital (CHU de Toulouse) | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017132 | Workplace |
| ID | Term |
|---|---|
| D004651 | Employment |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D010559 | Personnel Management |
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| National Cancer Institute, France | OTHER_GOV |
| French National Institute for Prevention and Education in Health (INPES) | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| French Inter-Departemental Agency for the Fight against Drugs and Addictive Behaviors (Mildeca) | UNKNOWN |
| French Social Security Scheme for Liberal Professionals (RSI) | UNKNOWN |
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| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |