Mitigating Heat Stress Among Rickshaw Drivers in Bangladesh

NCT06956430 | Not Yet Recruiting

• 1 other identifier: 2023-05-16316
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Core Temperature; Telomere Length, Mean Leukocyte; Kidney Function Issue

Keywords

heat stress; heat strain; rickshaw; heart rate; heart rate variability; sleep quality; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Core temperature

  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 Outcomes (5)

• Relative Leucocyte Telomere Length

  0 (pre-intervention) and 16 weeks post-intervention

• Kidney function

  0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention

• Heart rate

  0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention

• Heart rate variability

  0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention

• Sleep quality

  0 (pre-intervention) and 2, 4, 6, 8, 10, 12, 14, 16 weeks post-intervention

Study Arms (2)

Manual rickshaw

NO INTERVENTION

Rickshaw drivers will use manually powered rickshaws

Battery-powered rickshaw

EXPERIMENTAL

Rickshaw drivers will use battery-powered rickshaws

Device: Battery-powered rickshaw

Interventions

Battery-powered rickshaw DEVICE

A battery-powered rickshaw is a rickshaw where the wheels are turned by a small electric motors powered by a battery.

Battery-powered rickshaw

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Self-identify as a male. We will use this information about gender only as a proxy for sex, as we will not be assessing sex through chromosomal analysis.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reports driving a manual rickshaw at least five days per week for at least 8 hours per day for the past 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• North South University: collaborator

MeSH Terms

Conditions

Heat Stress Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Laura Kwong, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Kwong, PhD

CONTACT

16504609593; lakwong@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge randomized controlled trial

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: June 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: We expect that data and code will become available by 1 Jan 2027