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1/2- Bangladesh Center for Global Environmental and Occupational Health- Bangladesh

Study acronym: GEOHealth-II
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary completion date: Aug 31, 2027 to May 2027v3 Show 4 more changesShow less
    • Study completion date: Aug 31, 2027 to Jun 2027
    • Start date: Jun 21, 2023 to Jun 20, 2023
    • Eligibility criteria revised
    • Study description shortened, about 36 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 400 to 1000
    • Start date changed from estimate of Dec 1, 2022 to Jun 21, 2023
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass (wood, agricultural residue, cow dung, etc.) fuel use for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use, especially in low- and middle-income countries (LMICs). Earlier the investigators showed that Liquid Petroleum Gas (LPG) for 24 months, reduced personal PM2.5 exposure by 58.17 percent which induced novel changes in immune and inflammatory responses in the participants; however cardiopulmonary markers remained relatively stable in post-intervention assessment. In this study, the investigators aim to evaluate the effects of mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention on adoption and exclusive use of LPG. The investigators also aimed to observe whether long-term effects of HAP reduction can impact the subclinical measures of cardio-vascular and pulmonary dysfunction and regulate innate and inflammatory immune function among women and children in semi-rural settings in Bangladesh. The investigators will also investigate the influence of exposure to HAP on antibody response to vaccines (adaptive immunity). The BCC intervention will be provided by conducting a large household level randomized controlled trial by educational intervention using mHealth based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.
Trial Details
NCT Number NCT05570552
Lead Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: University of Chicago, Mailman School of Public Health, Marquette University
Conditions
(from sponsor)
Air Pollution, mHealth Intervention, Cardiopulmonary Function, Immune Function
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov