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Stepped-wedge cluster-randomised controlled trial to assess the cardiovascular health effects of a managed aquifer recharge initiative to reduce drinking water salinity in southwest coastal Bangladesh: study design and rationale
  1. Abu Mohd Naser1,
  2. Leanne Unicomb2,
  3. Solaiman Doza2,
  4. Kazi Matin Ahmed3,
  5. Mahbubur Rahman2,
  6. Mohammad Nasir Uddin2,
  7. Shamshad B Quraishi4,
  8. Shahjada Selim5,
  9. Mohammad Shamsudduha6,
  10. William Burgess7,
  11. Howard H Chang8,
  12. Matthew O Gribble1,
  13. Thomas F Clasen1,
  14. Stephen P Luby9
  1. 1 Department of Environmental Health Sciences, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
  2. 2 Environmental Health & Interventions Unit, Enteric and Respiratory Infections Program, Infectious Disease Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh
  3. 3 Department of Geology, Dhaka University, Dhaka, Bangladesh
  4. 4 Analytical Chemistry Laboratory, Atomic Energy Centre, Bangladesh Atomic EnergyCommission, Dhaka, Bangladesh
  5. 5 Department of Endocrinology & Metabolism, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  6. 6 Institute for Risk and Disaster Reduction, Departmentof Geography, University College London, London, UK
  7. 7 Department of Earth Sciences, University College London, London, UK
  8. 8 Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
  9. 9 Stanford Woods Institute for the Environment & Freeman Spogli Institute for International Studies, Stanford University, Stanford, California, USA
  1. Correspondence to Dr Abu Mohd Naser; atitu{at}emory.edu

Abstract

Introduction Saltwater intrusion and salinisation have contributed to drinking water scarcity in many coastal regions globally, leading to dependence on alternative sources for water supply. In southwest coastal Bangladesh, communities have few options but to drink brackish groundwater which has been associated with high blood pressure among the adult population, and pre-eclampsia and gestational hypertension among pregnant women. Managed aquifer recharge (MAR), the purposeful recharge of surface water or rainwater to aquifers to bring hydrological equilibrium, is a potential solution for salinity problem in southwest coastal Bangladesh by creating a freshwater lens within the brackish aquifer. Our study aims to evaluate whether consumption of MAR water improves human health, particularly by reducing blood pressure among communities in coastal Bangladesh.

Methods and analysis The study employs a stepped-wedge cluster-randomised controlled community trial design in 16 communities over five monthly visits. During each visit, we will collect data on participants’ source of drinking and cooking water and measure the salinity level and electrical conductivity of household stored water. At each visit, we will also measure the blood pressure of participants ≥20 years of age and pregnant women and collect urine samples for urinary sodium and protein measurements. We will use generalised linear mixed models to determine the association of access to MAR water on blood pressure of the participants.

Ethics and dissemination The study protocol has been reviewed and approved by the Institutional Review Boards of the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b). Informed written consent will be taken from all the participants. This study is funded by Wellcome Trust, UK. The study findings will be disseminated to the government partners, at research conferences and in peer-reviewed journals.

Trial registration number NCT02746003; Pre-results.

  • stepped-wedge trial
  • managed aquifer recharge
  • blood pressure
  • sodium intake
  • drinking saline water

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors SPL and AMN developed the study concept. AMN, SPL, LU, KMA and SD have developed the study design. MR, MOG, TFC and HHC reviewed the epidemiological study design. KMA, MS, WB, SS and MNU provided input in environmental and biological sample collection and analysis. HHC and MOG provided input in statistical analysis. AMN drafted and all authors reviewed the manuscript.

  • Funding The study has been funded by Wellcome Trust, UK (Grant no. 106871/Z/15/Z), Our Planet, Our Health Award. Wellcome Trust reviewed and approved the design as the condition of providing funding but will not have a role in data collection, data analysis, data interpretation or writing of the report. The study was implemented by International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). icddr,b acknowledges with gratitude the commitment of Wellcome Trust, UK, to its research efforts. icddr,b is also grateful to the Governments of Bangladesh, Canada, Sweden and the UK for providing core/unrestricted support. MOG is supported by funding from the National Institute for Environmental Health Sciences to the Emory Health and Research Exposome Center (P30 ES019776).

  • Competing interests None declared.

  • Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.

  • Ethics approval ERC of International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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