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Cardiovascular DiseasesHeart-Of-NightNCT02899442

Cardiovascular Risk Prevention Among Night Workers

A study testing collective prevention in workplace in people with Cardiovascular Diseases, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
collective prevention in workplace
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,056 participants
Where
1 siteFrance
Study dates
Sep 2015to Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Toulouse University Hospital (CHU de Toulouse)

    Toulouse, 31059

Other trials in France

About this study

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:

Read more

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.
Read the detailed description

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.

  • Research objectives 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.
  • Methodology This study is designed as a multicenter, cluster randomized interventional controlled trial, to reduce the incidence of metabolic syndrome among night workers. Randomization will be performed on 100 occupational physicians (volunteers to participate), to apply one of both interventions. 3056 volunteers' night workers will be recruited from the employees regularly monitored by each physician during the routine medical monitoring. Two parallel groups will be performed: control group and experimental group. A two-year follow-up will be organized including check-points every 6 months. Control group: Every 6 months (T0, 6, 12, 18 months), standardized preventive individual advice focused on cardiovascular risk in night workers will be delivered by occupational physicians. Experimental group: In addition to this individual advice, preventive interventions dispensed on worksite will be carried out. Counter-measures will be applied by occupational health team to improve working conditions. By using a self-questionnaire, a medical questionnaire, a medical examination, biological sample, and specific follow-up of preventive interventions, the assessments will be performed. Study Primary outcome: Reduction of incidence of metabolic syndrome between the two groups (control and experimental) over 2 years' follow up.

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.
Being tested
collective prevention in workplace
Keywords
cardiovascular risk, Occupational Health, night work, Public Health, Preventive Health Services
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • collective prevention in workplaceOther

    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

Study groups in NCT02899442
Study groupRoleWhat they receive
individual preventionNo interventionThe 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 preventionExperimentalIn 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).
Receives: Other: collective prevention in workplace

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: inclusion (T0), and 24 months (T24)

Secondary outcomes (1)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2021
  4. Study completionSep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,056 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02899442
Sponsor's protocol ID
RC31/14/7341
Other IDs
2015-A00895-44
Acronym
Heart-Of-Night
Status last verified
Mar 2024
First submitted
2 Sep 2016
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing collective prevention in workplace in people with Cardiovascular Diseases, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Metabolic Syndrome Factors (time frame: inclusion (T0), and 24 months (T24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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