- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06956430
Mitigating Heat Stress Among Rickshaw Drivers in Bangladesh
May 15, 2025 updated by: University of California, Berkeley
How Does Heat Stress Affect Telomere Length? A Pilot Randomized Controlled Trial in Urban Bangladesh
The goal of the experimental study is to understand the impact of heat stress on core temperature and telomere length.
Investigators will recruit rickshaw drivers who use manual power to push their rickshaws and randomly assign half of them to receive battery-powered rickshaws to use for four months.
Investigators will assess how this change impacts their core body temperature while they work, the length of their telomeres (caps on the end of DNA that are associated with aging), and kidney function.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Personal exposure to heat may be elevated above ambient temperatures if an individual is very active (which generates metabolic heat) or wears clothing that prevents cooling.
Age can influence the consequences of heat stress.
Older adults are at elevated risk of adverse impacts from heat stress due to their reduced ability to dissipate heat.
Heat stress is particularly high among outdoor workers.
South Asia has millions of bicycle rickshaw drivers, who use their muscles or battery power to pull hundreds of pounds of passengers and goods on modified bicycles.
When manual rickshaw drivers rest to cool off, they reduce their already meager income.
Heat stress not only threatens their livelihoods and thereby their right to an adequate standard of living but also their right to work, given that they have few employable skills other than manual labor.
South Asia faces the greatest current and predicted loss in disability-adjusted life years due to heat stress, and heat stress is particularly strong in informal settlements.
As such, the investigators plan to conduct this study in Dhaka, Bangladesh.
The overall hypothesis is that driving a battery-powered rickshaw will reduce heat strain.
The investigators will evaluate the impact of driving a battery-powered rickshaw on core temperature (primary outcome), telomere length, kidney function, heart rate, heart rate variability, sleep quality, self-reported thermal comfort, mental health, wellness, and fatigue (secondary outcomes).
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura Kwong, PhD
- Phone Number: 16504609593
- Email: lakwong@berkeley.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Reports driving a manual rickshaw at least five days per week for at least 8 hours per day for the past 12 months
Exclusion Criteria:
- Reports driving a battery-powered rickshaw in the past 12 months
- Has hypertension, as measured by our study staff
- Has diabetes, as measured by our staff
- Reports diagnosis with cardiovascular disease / chronic cardiac condition
- Reports diagnosis with respiratory disease / chronic respiratory condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Manual rickshaw
Rickshaw drivers will use manually powered rickshaws
|
|
|
Experimental: Battery-powered rickshaw
Rickshaw drivers will use battery-powered rickshaws
|
A battery-powered rickshaw is a rickshaw where the wheels are turned by a small electric motors powered by a battery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core temperature
Time Frame: 0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
Minutes per day that core temperature is >40C, where fewer minutes per day is better
|
0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative Leucocyte Telomere Length
Time Frame: 0 (pre-intervention) and 16 weeks post-intervention
|
Change in Relative Leucocyte Telomere Length measured by PCR, where a smaller reduction in length is better
|
0 (pre-intervention) and 16 weeks post-intervention
|
|
Kidney function
Time Frame: 0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
kidney function, as measured by a the neutrophil gelatinase-associated lipocalin (NGAL) value in urine samples, where a lower score is better
|
0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
|
Heart rate
Time Frame: 0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
resting heart rate (bpm), where a lower heart rate is better
|
0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
|
Heart rate variability
Time Frame: 0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
resting heart rate (bpm) variability, where higher variability is better
|
0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
|
Sleep quality
Time Frame: 0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
Self-reported sleep quality and number of minutes in REM, as recorded by a fitness watch, where more minutes in REM is better
|
0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Laura Kwong, PhD, University of California, Berkeley
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2025
Primary Completion (Estimated)
October 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
April 25, 2025
First Submitted That Met QC Criteria
April 25, 2025
First Posted (Actual)
May 4, 2025
Study Record Updates
Last Update Posted (Actual)
May 21, 2025
Last Update Submitted That Met QC Criteria
May 15, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-05-16316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will post de-identified participant data on our OSF repository (https://osf.io/sd285/)
IPD Sharing Time Frame
We expect that data and code will become available by 1 Jan 2027
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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