Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000457741
Ethics application status
Approved
Date submitted
17/03/2022
Date registered
23/03/2022
Date last updated
23/02/2024
Date data sharing statement initially provided
23/03/2022
Date results information initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Sustainable cooling strategies for use in garment factories in low- and middle-income countries
Scientific title
Mitigating extreme heat and thermal strain in Bangladeshi garment factories using sustainable cooling strategies
Secondary ID [1] 306705 0
None
Universal Trial Number (UTN)
Trial acronym
SFCS: Sustainable Factory Cooling Strategies
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heat related thermal strain 325671 0
Heat related cardiovascular strain 325672 0
Heat related changes in thermal perceptions (i.e., comfort, sensation, thirst) 325673 0
Condition category
Condition code
Public Health 323019 323019 0 0
Other public health
Cardiovascular 323020 323020 0 0
Normal development and function of the cardiovascular system
Injuries and Accidents 323021 323021 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will take part in 6 experimental trials consisting of 3 hour of simulated heat-stress exposure which replicates the thermal conditions observed inside a Bangladeshi garment factory. The experimental trials will be randomised and will consist of:

1. No cooling (standard practice comparator). Current factory conditions (40°C, 38% relative humidity)
2. Electric fan use (Current factory conditions (40°C, 38% relative humidity))
3. Electric fan use and water consumption (Current factory conditions (40°C, 38% relative humidity))
4. Green roof (internal factory conditions obtainable via the implementation of external building modifications, 37°.5C. 38% relative humidity)
5. Green roof and electric fan use (internal factory conditions obtainable via the implementation of external building modifications, 37°.5C. 38% relative humidity)
6. Air-conditioning (positive control, 24°C, 40% relative humidity)

All experimental trials will be conducted in a climate-controlled chamber, In each exposure, participants will be asked to complete occupational task simulations which mimic sewing and ironing activities (the tasks predominately conducted in ready-made garment factories). Physiological and perceptual responses will be monitored throughout each trial. Each trial will be separated by at least 24 h.

Participants will be assigned to the 'sewing' and 'ironing' simulations based on sex: females will be assigned to the sewing task and males to the ironing task. These selections reflect the roles typically performed by workers in in Ready Made Garment Factories in Bangladesh.

Compliance/adherence to the 'sewing' and 'ironing' task simulations will be confirmed by the researchers who will supervise participants at all times throughout each experimental trial.

Additional details:

No cooling: Participants will conduct the simulated work tasks without cooling intervention.
Electric fan use: Participants will conduct the simulated work tasks with an electric fan directed at the work-station, providing a wind speed on 1.5 m/s.

Electric fan use and water consumption: Participants will conduct the simulated work tasks with and electric fan directed at the work-station, providing a wind speed on 1.5 m/s. Additionally, participants will be provided with 250mL of water every 30 minutes which they can drink ad libitum.

Green roof: participants will complete the simulated work tasks in a slightly cooler environment (37.5°C). This reduction in temperature represents the magnitude of change that is achievable by implementing modifications to the factory building (i.e. the instalment of a “green-roof” consisting of vegetative layer).

Green roof and electric fan use: participants will complete the simulated work tasks in a slightly cooler environment (37.5°C). This reduction in temperature represents the magnitude of change that is achievable by implementing modifications to the factory building (i.e. the instalment of a “green-roof” consisting of vegetative layer). Additionally, an electric fan directed at the work-station, providing a wind speed on 1.5 m/s.

Air-conditioning: participants will complete the simulated work tasks in a much cooler environment (24°C). This environment represents the temperature that is achievable with the use of a conventional air-conditioning system. This experimental exposure will serve as a positive control.
Intervention code [1] 323150 0
Prevention
Comparator / control treatment
The comparator is a heat-stress exposure with no cooling intervention. Participants will conduct the simulated work tasks without cooling intervention in currently observed factory conditions (40°C, 38% relative humidity).
Control group
Active

Outcomes
Primary outcome [1] 330787 0
Core body temperature measure via telemetric gastrointestinal temperature pill:

The core temperature sensor (E-celcius, BodyCap™) will be used to assess gastrointestinal temperature. The sensor will be swallowed ~6 hours prior to arriving at the laboratory, so that the sensor has progressed past the stomach by the time the experimental session begins.
Timepoint [1] 330787 0
Difference between pre- to post- 3 h heat exposure
Primary outcome [2] 330788 0
Heart Rate

Heart rate will be measured continuously during the experimental visits via a Polar heart rate monitor.
Timepoint [2] 330788 0
Difference between pre- to post- 3 h heat exposure.
Primary outcome [3] 330789 0
Whole body sweat rate Participants will provide a nude weight (in private) before and immediately after the heat stress exposure on a calibrated digital scale. Whole-body sweat rate will be calculated as the difference in the pre and post weight, divided by the time between recorded weigh-ins.
Timepoint [3] 330789 0
Difference between pre- to post- 3 h heat exposure.
Secondary outcome [1] 407558 0
Skin temperature Skin temperature will be measured continuously during the exposures by taping 4 small sensors to the skin surface on the right side at the upper arm, chest, thigh and upper calf.
Timepoint [1] 407558 0
Difference between pre- to post- 3h heat exposure
Secondary outcome [2] 407559 0
Perceptual changes in thermal discomfort

Thermal discomfort will be measured at baseline and every 30 minutes during the 3 h heat exposure protocol using a visual analog scale.
Timepoint [2] 407559 0
Difference between pre- to post- 3h heat exposure.
Secondary outcome [3] 407560 0
Perceptual changes in thermal sensation

Thermal sensation will be measured at baseline and every 30 minutes during the 3 h heat exposure protocol using a visual analog scale.
Timepoint [3] 407560 0
Difference between pre- to post- 3h heat exposure.
Secondary outcome [4] 407561 0
Perceptual changes in thirst

Thirst will be measured at baseline and every 30 minutes during the 3 h heat exposure protocol using a visual analog scale.
Timepoint [4] 407561 0
Difference between pre- to post- 3h heat exposure.
Secondary outcome [5] 407562 0
Work performance

Work performance will be quantified by assessing the number of garments sewn/ironed during the exposure.
Timepoint [5] 407562 0
End of the 3 hour heat stress exposure,

Eligibility
Key inclusion criteria
Males and females aged 18 to 40.
Non-smokers with no history of respiratory, metabolic, cardiovascular, blood pressure disease, or of diabetes and not currently on any medication related to these conditions).
No difficult understanding or speaking English.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Uncontrolled hypertension (greater than 180/110 mmHg).
- Uncontrolled diabetes or severe complications of diabetes.
- Evidence of severe renal disease, liver disease, cerebrovascular disease, pulmonary disease, endocrine abnormalities, cognitive impairment, psychiatric disorder, substance abuse, degenerative neurological condition or any other medical condition deemed to pose risk during the study visits.
- Medication known to cause hyper- or hypo-hidrosis (except those taken for hypertension).
- Currently taking a beta-blocker.
- Evidence of current fluid and electrolyte disorders
- Current diagnosis of anemia
- Abnormal thyroid function
- Significant cognitive impairment, psychiatric disorder, substance abuse, degenerative neurological condition
- Any other medical condition deemed to pose risk during the proposed testing or experiments.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised via a central computer database in a balanced order of males and female
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
40 participants will complete the study. To account for a potential 20% participant drop-out rate, we expect to recruit up to 48 participants. The number of participants was determined by performing a power calculation using an a of 0.05, a ß of 0.1, an effect size of 0.8 calculated from data presented in Morris et al., 2019 (The Effects of Electric Fan Use Under Differing Resting Heat Index Conditions: A Clinical Trial. Annals of Internal Medicine). This sample size enables stratification of participants into two distinct groups (20 participants in the sewing intervention group, 20 participants in the ironing intervention group) and is powered sufficiently to detect changes in thermal strain (changes in body temperature and thermal comfort) resulting from the various low-cost cooling interventions.

Primary and secondary outcome variables: One-way repeated measures ANOVA models will be used to compare the end of trial change in primary and secondary outcome variables. Pairwise comparisons will allow for comparison of the 6 separate experimental exposures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2022
Actual
1/05/2022
Date of last participant enrolment
Anticipated
3/07/2023
Actual
2/10/2023
Date of last data collection
Anticipated
30/09/2023
Actual
20/12/2023
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37088 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 311035 0
Charities/Societies/Foundations
Name [1] 311035 0
Wellcome Trust
Country [1] 311035 0
United Kingdom
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown
NSW
2006
Country
Australia
Secondary sponsor category [1] 312361 0
None
Name [1] 312361 0
None
Address [1] 312361 0
N/a
Country [1] 312361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310583 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 310583 0
Research Integrity and Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
Camperdown, NSW
2006
Ethics committee country [1] 310583 0
Australia
Date submitted for ethics approval [1] 310583 0
08/07/2021
Approval date [1] 310583 0
18/10/2021
Ethics approval number [1] 310583 0
2021/583

Summary
Brief summary
Bangladesh is a developing country that produces a large proportion of the world’s Ready-Made Garments (RMG), employing millions of workers from the country’s low-socioeconomic demographic. These workers are faced with tough working conditions, high workloads and low wages. Monitoring the internal conditions of Bangladeshi RMG factories has shown that these workers are subjected to very high ambient temperatures (~40°C) with high relative humidity (~40%) These conditions render workers vulnerable to dangerous levels of heat-stress and the development of heat-related illness. Therefore, we aim to examine the efficacy of sustainable, low-cost cooling strategies that may be implemented in RMG factories to help improve the internal thermal conditions and reduce the heat-strain experienced by workers.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118162 0
Prof Ollie Jay
Address 118162 0
Thermal Ergonomics Laboratory, Room 901
Susan Wakil Health Building
The University of Sydney
Camperdown, NSW 2006
Country 118162 0
Australia
Phone 118162 0
+61 2 93519328
Fax 118162 0
Email 118162 0
ollie.jay@sydney.edu.au
Contact person for public queries
Name 118163 0
Prof Ollie Jay
Address 118163 0
Thermal Ergonomics Laboratory, Room 901
Susan Wakil Health Building
The University of Sydney
Camperdown, NSW 2006
Country 118163 0
Australia
Phone 118163 0
+61 2 93519328
Fax 118163 0
Email 118163 0
ollie.jay@sydney.edu.au
Contact person for scientific queries
Name 118164 0
Prof Ollie Jay
Address 118164 0
Thermal Ergonomics Laboratory, Room 901
Susan Wakil Health Building
The University of Sydney
Camperdown, NSW 2006
Country 118164 0
Australia
Phone 118164 0
+61 2 93519328
Fax 118164 0
Email 118164 0
ollie.jay@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data will be available in published study results
When will data be available (start and end dates)?
Immediately following publication - no end date.
Available to whom?
Within published journals and case by case at the discretion of the primary sponsor.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Access subject to approvals by the Principal Investigator with a requirement to sign data access agreements. Access can be obtained by emailing: ollie.jay@sydney.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.