Effects of Interventions to Prevent Work-related Asthma, Allergy and Other Hypersensitivity Reactions in Norwegian Salmon Industry Workers (SHInE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,113
- Locations
- 1
- Primary Endpoint
- Change of salmon processing workers' personal exposure to inhalable protein
Study Overview
Brief Summary
Workers in the salmon industry are at risk of developing allergies and respiratory diseases, including asthma, due to occupational exposure to bioaerosols, i.e. biological agents such as allergens, enzymes and endotoxins, in their work environment. The overall objective of this intervention trial is to identify effective and feasible control measures (interventions) that reduce exposure to these bioaerosols.
The project comprises nine salmon processing factories in northern, central and western Norway. The factories are allocated to either one of the two intervention arms or the control group. In all factories, an assessment of exposure to bioaerosols will be performed. In addition, employees will be invited to undergo a health examination and fill out a self-administered questionnaire including information on demographics, work tasks, health and health promoting factors.
The intervention trial is part of a broader study that comprises several substudies including the identification of clinically relevant allergens, investigation of exposure-response relationship between the exposure to individual bioactive agents in bioaerosols and investigations of prevalence of airway symptoms, altered lung function, skin symptoms or immunological responses indicating hypersensitivity. Finally the project includes the identification of health promoting factors that are present in the salmon processing industry.
The project is an interdisciplinary multi-center study that places great emphasis on a close dialogue between the researchers and industry in all phases of the project.
Detailed Description
The intervention trial is part of a broader study on assessment of exposure and health of workers in the salmon industry. Measurements of exposure, health examinations and questionnaire data serve as a basis for both intervention- and other substudies.
The intervention trial itself is a parallel group, three-arm non-randomized superiority trial with a 1:1:1 allocation.
Processing of salmon includes two main processes: 1) in the slaughtering department, the fish are slaughtered, sorted, automatically or manually gutted, and washed before further processing; and 2) in the filleting department, the salmon is filleted and skinned by machines before manual trimming of the fillets. The main source of exposure to fish proteins is by inhalation of wet bioaerosols containing a heterogeneous mixture of proteins, enzymes, endotoxins and microorganisms.
It is hypothesized that a reduction in exposure will cause a decrease in the prevalence of symptoms from the airways and skin, as well as sensitization, in workers of factories that implement the exposure-reducing measures.Hence, the overall aim of identifying effective and feasible control measures (interventions) that reduce exposure to these bioaerosols is to lower the risk of, or preferably prevent, the development or chronification of respiratory diseases, eczema and allergy among salmon processing workers.
The main hypothesis behind the interventions is that control measures that aim at using less water, at reduction of bioaerosol generation or at shielding workers from the production line have the potential to reduce bioaerosol exposure. The three arms of the trial are therefore 1) technical intervention targeting alteration of nozzles or nozzle function along the production line (NZ), 2) behavioral or technical intervention related to cleaning of surfaces (CS), or 3) no intervention (control). Each of the intervention arms represents a general intervention category in which details for the actual intervention are to be developed in collaboration with the factory staff to maximize the effect of the interventions.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Eligibility criteria will differ depending on the type of data gathering volunteers participate in:
- •Questionnaire Inclusion Criteria: All workers employed in the factory
Exclusion Criteria
- •No restrictions
- •Exposure assessment study
- •Inclusion Criteria: Participants (12 workers each day, two repeated measurements = 24 workers) will be collected at random among workers having the following work stations/tasks during the study period:
- •Monday and Thursday (n=12 workers): Slaughtering department (n=5), filleting department (n=4) and other (n=3).
- •Tuesday and Wednesday (n=12 workers): Slaughtering department (n=3), filleting department (n=3), packing department (n=2), laboratory/technical department (n=2) and central control room/administration (n=2).
- •Exclusion Criteria: Not working in those areas, not able to wear backpack with equipment.
- •Cross-week follow-up (Monday to Thursday) Inclusion Criteria: Participant in both 1 and 2, i.e. having filled out questionnaire and participated in exposure measurement on mondays.
- •Exclusion Criteria: Not fulfilling inclusion criteria, not able to wear backpack with equipment.
- •Health examinations Inclusion criteria: All subjects working in the factories during the field work period of four days will be eligible. However, due to logistic constraints we aim to invite at least 20 subjects each day, primarily those working in the salmon production line. Those invited will be randomly selected according to a distribution between slaughtering, filleting and others (ratio 5:4:3).
- •Exclusion criteria:
- •For spirometry measurements: heart attack, operation on eyes, stomach or in the chest region in the course of the last three months, ongoing treatment for tuberculosis or other respiratory infection, pregnancy
- •For skin prick tests: pregnancy
Arms & Interventions
Nozzles (NZ)
Intervention with the aim of reducing bioaerosol exposure for the employees, targeting alteration of nozzles or nozzle function along the production line.
Intervention: Nozzles (NZ) (Other)
Cleaning of surfaces (CS)
Intervention with the aim of reducing bioaerosol exposure for the employees while cleaning their personal operating areas (work benches and part of production lines) during work operations or while cleaning floor areas.
Intervention: Cleaning of surfaces (CS) (Other)
Control (CTR)
Work is to be carried out as usual without any intervention measures. Follow-up according to the same schedule as for the other intervention groups.
Outcomes
Primary Outcomes
Change of salmon processing workers' personal exposure to inhalable protein
Time Frame: Measurements at T1 compared to T2, 12 months after T1.
Change in inhalable total protein (ug/m3) in the workers' breathing zone from pre-intervention (baseline, T1) to post-intervention (follow-up, T2). Differences in mean concentration of full shift measurements (8 hours) between intervention groups and between intervention groups and control group will be analyzed.
Secondary Outcomes
- Change of salmon processing workers' personal exposure to airborne fish allergens(Measurements at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' self-reported symptoms from the upper airways(Data collected at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' self-reported symptoms from the lower airways(Data collected at T1 compared to T2, 12 months after T1.)
- Change of salmon processing workers' personal exposure to proteases(Measurements at T1 compared to T2, 12 months after T1.)
- Change of salmon processing workers' personal exposure to airborne endotoxins(Measurements at T1 compared to T2, 12 months after T1.)
- Change in area concentration of airborne total protein (stationary measurements)(Measurements at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' self-reported eye symptoms(Data collected at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' lung function at group level (FEV1 in % of predicted)(Measurements at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' lung function at individual level (maximum forced expired volume in 1 second (FEV1)/forced vital capacity (FVC) ratio)(Data collected at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' cross-week lung function (FEV1)(Measurements at T1 compared to T2, 12 months after T1.)
- Incidence of salmon processing workers' sensitization to salmon(Measurements at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' cross-shift lung function (FEV1)(Measurements at T1 compared to T2, 12 months after T1.)
- Change in salmon processing workers' self-reported skin symptoms(Data collected at T1 compared to T2, 12 months after T1.)