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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Manual rickshaw
Rickshaw drivers will use manually powered rickshaws
Experimental: Battery-powered rickshaw
Rickshaw drivers will use battery-powered rickshaws
Device: Battery-powered rickshaw
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
International Centre for Diarrhoeal Disease Research, Bangladesh
North South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings