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Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana (REACCTING)

Primary Purpose

Inflammation, Growth Retardation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Philips stove
Gyapa stove
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

0 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion

Individual Participants:

  • Classified as "rural"
  • Uses biofuel as main cooking fuel source (firewood, animal waste, crop residue/sawdust)
  • Uses borehole as main water source (to facilitate social network analysis linking household's knowledge and attitudes toward stoves to experience of social contacts);
  • Does not have electricity (to permit possible addition of lighting intervention at a later date);
  • Has a woman in household aged 18-55 and at least one child under five (since women and children are the most vulnerable to cookstove smoke and are thus the main focus of our health measures).

Clusters:

  • No more than 25% classified as urban
  • Accessible year-round (determined by field staff)
  • Having at least 10 eligible households (in line with the participant criteria above)

Exclusion:

  • Household could not be located
  • Household declined to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    Gyapa/Gyapa

    Gyapa/Philips

    Philips/Philips

    Arm Description

    Households enrolled in the control arm of the study did not receive either improved cookstove

    Households enrolled in the Gyapa/Gyapa arm of the study received two Gyapa stoves for free

    Households enrolled in the Gyapa/Philips arm of the study received one Gyapa stove and one Philips stove for free

    Households enrolled in the Philips/Philips arm of the study received two Philips stoves for free

    Outcomes

    Primary Outcome Measures

    Health (Biomarkers of inflammation)
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Health (Biomarkers of inflammation)
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Health (Biomarkers of inflammation)
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Health (Biomarkers of inflammation)
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Height
    Height of participants
    Height
    Height of participants
    Height
    Height of participants
    Height
    Height of participants
    Weight
    Weight of participants
    Weight
    Weight of participants
    Weight
    Weight of participants
    Weight
    Weight of participants
    Mid-arm circumference
    Measurement of mid-upper arm circumference of participants
    Mid-arm circumference
    Measurement of mid-upper arm circumference of participants
    Mid-arm circumference
    Measurement of mid-upper arm circumference of participants
    Mid-arm circumference
    Measurement of mid-upper arm circumference of participants

    Secondary Outcome Measures

    Personal exposure to fine particulate matter (PM2.5)
    48 hour integrated personal PM2.5 concentrations from filter measurements
    Personal exposure to carbon monoxide (CO)
    Daily average and integrated personal CO concentrations
    Kitchen area concentrations of carbon monoxide (CO)
    Daily average and integrated kitchen area CO concentrations
    Kitchen area concentrations of fine particulate matter (PM2.5)
    48 hour integrated kitchen area PM2.5 concentrations from filter measurements
    Self-reported stove usage
    Surveys administered to respondents (primary cooks)
    Self-reported stove usage
    Surveys administered to respondents (primary cooks)
    Self-reported stove usage
    Surveys administered to respondents (primary cooks)
    Self-reported stove usage
    Surveys administered to respondents (primary cooks)
    Stove usage as measured by devices
    Continuous stove usage indicators as measured by temperature loggers on stoves

    Full Information

    First Posted
    September 14, 2020
    Last Updated
    November 11, 2020
    Sponsor
    University of Colorado, Boulder
    Collaborators
    Environmental Protection Agency (EPA), U.S. National Science Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04633135
    Brief Title
    Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana
    Acronym
    REACCTING
    Official Title
    Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2012 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Colorado, Boulder
    Collaborators
    Environmental Protection Agency (EPA), U.S. National Science Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    REACCTING (Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana) is an interdisciplinary randomized cookstove intervention study in the Kassena-Nankana District of Northern Ghana. The study tests two types of biomass burning stoves that have the potential to meet local cooking needs and represent different "rungs" in the cookstove technology ladder: a locally-made, low-tech Gyapa rocket stove and the imported, highly efficient Philips gasifier stove. Intervention households were randomized into four different groups, three of which received different combinations of two improved stoves, while the fourth group serves as a control for the duration of the study. Diverse measurements assess different points along the causal chain linking the intervention to final outcomes of interest. The investigators assess stove use and cooking behavior, cooking emissions, household air pollution and personal exposure, health burden, and local to regional air quality. Integrated analysis and modeling will tackle a range of interdisciplinary science questions, including examining ambient exposures among the regional population, assessing how those exposures might change with different technologies and behaviors, and estimating the comparative impact of local behavior and technological changes versus regional climate variability and change on local air quality and health outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammation, Growth Retardation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    There were 4 groups, 3 intervention and 1 control, all operating over the same period.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Households enrolled in the control arm of the study did not receive either improved cookstove
    Arm Title
    Gyapa/Gyapa
    Arm Type
    Experimental
    Arm Description
    Households enrolled in the Gyapa/Gyapa arm of the study received two Gyapa stoves for free
    Arm Title
    Gyapa/Philips
    Arm Type
    Experimental
    Arm Description
    Households enrolled in the Gyapa/Philips arm of the study received one Gyapa stove and one Philips stove for free
    Arm Title
    Philips/Philips
    Arm Type
    Experimental
    Arm Description
    Households enrolled in the Philips/Philips arm of the study received two Philips stoves for free
    Intervention Type
    Device
    Intervention Name(s)
    Philips stove
    Other Intervention Name(s)
    Gasifier stove
    Intervention Description
    Philips Smokeless stove HD4012LS
    Intervention Type
    Device
    Intervention Name(s)
    Gyapa stove
    Other Intervention Name(s)
    Rocket stove
    Intervention Description
    Wood stove made in Ghana
    Primary Outcome Measure Information:
    Title
    Health (Biomarkers of inflammation)
    Description
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Time Frame
    At baseline
    Title
    Health (Biomarkers of inflammation)
    Description
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Time Frame
    At 6 months
    Title
    Health (Biomarkers of inflammation)
    Description
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Time Frame
    At 12 months
    Title
    Health (Biomarkers of inflammation)
    Description
    Health indicators from blood spot samples (C-Reactive Protein, Sicam, sVCAM, serum amyloid A, Interleukin-1b, Interleukin-6, Interleukin-8, tumor necrosis factor alpha).
    Time Frame
    At 18 months
    Title
    Height
    Description
    Height of participants
    Time Frame
    At baseline
    Title
    Height
    Description
    Height of participants
    Time Frame
    At 6 months
    Title
    Height
    Description
    Height of participants
    Time Frame
    At 12 months
    Title
    Height
    Description
    Height of participants
    Time Frame
    At 18 months
    Title
    Weight
    Description
    Weight of participants
    Time Frame
    At baseline
    Title
    Weight
    Description
    Weight of participants
    Time Frame
    At 6 months
    Title
    Weight
    Description
    Weight of participants
    Time Frame
    At 12 months
    Title
    Weight
    Description
    Weight of participants
    Time Frame
    At 18 months
    Title
    Mid-arm circumference
    Description
    Measurement of mid-upper arm circumference of participants
    Time Frame
    At baseline
    Title
    Mid-arm circumference
    Description
    Measurement of mid-upper arm circumference of participants
    Time Frame
    At 6 months
    Title
    Mid-arm circumference
    Description
    Measurement of mid-upper arm circumference of participants
    Time Frame
    At 12 months
    Title
    Mid-arm circumference
    Description
    Measurement of mid-upper arm circumference of participants
    Time Frame
    At 18 months
    Secondary Outcome Measure Information:
    Title
    Personal exposure to fine particulate matter (PM2.5)
    Description
    48 hour integrated personal PM2.5 concentrations from filter measurements
    Time Frame
    48 hour deployment periods
    Title
    Personal exposure to carbon monoxide (CO)
    Description
    Daily average and integrated personal CO concentrations
    Time Frame
    48 hour deployment periods
    Title
    Kitchen area concentrations of carbon monoxide (CO)
    Description
    Daily average and integrated kitchen area CO concentrations
    Time Frame
    48 hour deployment periods
    Title
    Kitchen area concentrations of fine particulate matter (PM2.5)
    Description
    48 hour integrated kitchen area PM2.5 concentrations from filter measurements
    Time Frame
    48 hour deployment periods
    Title
    Self-reported stove usage
    Description
    Surveys administered to respondents (primary cooks)
    Time Frame
    At baseline
    Title
    Self-reported stove usage
    Description
    Surveys administered to respondents (primary cooks)
    Time Frame
    At 6 months
    Title
    Self-reported stove usage
    Description
    Surveys administered to respondents (primary cooks)
    Time Frame
    At 12 months
    Title
    Self-reported stove usage
    Description
    Surveys administered to respondents (primary cooks)
    Time Frame
    At 18 months
    Title
    Stove usage as measured by devices
    Description
    Continuous stove usage indicators as measured by temperature loggers on stoves
    Time Frame
    Throughout data collection period, approximately 2 years.

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Individual Participants: Classified as "rural" Uses biofuel as main cooking fuel source (firewood, animal waste, crop residue/sawdust) Uses borehole as main water source (to facilitate social network analysis linking household's knowledge and attitudes toward stoves to experience of social contacts); Does not have electricity (to permit possible addition of lighting intervention at a later date); Has a woman in household aged 18-55 and at least one child under five (since women and children are the most vulnerable to cookstove smoke and are thus the main focus of our health measures). Clusters: No more than 25% classified as urban Accessible year-round (determined by field staff) Having at least 10 eligible households (in line with the participant criteria above) Exclusion: Household could not be located Household declined to participate

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    De-identified data are available upon request.
    Citations:
    PubMed Identifier
    25885780
    Citation
    Dickinson KL, Kanyomse E, Piedrahita R, Coffey E, Rivera IJ, Adoctor J, Alirigia R, Muvandimwe D, Dove M, Dukic V, Hayden MH, Diaz-Sanchez D, Abisiba AV, Anaseba D, Hagar Y, Masson N, Monaghan A, Titiati A, Steinhoff DF, Hsu YY, Kaspar R, Brooks B, Hodgson A, Hannigan M, Oduro AR, Wiedinmyer C. Research on Emissions, Air quality, Climate, and Cooking Technologies in Northern Ghana (REACCTING): study rationale and protocol. BMC Public Health. 2015 Feb 12;15:126. doi: 10.1186/s12889-015-1414-1.
    Results Reference
    background
    PubMed Identifier
    34863138
    Citation
    Abdo M, Kanyomse E, Alirigia R, Coffey ER, Piedrahita R, Diaz-Sanchez D, Hagar Y, Naumenko DJ, Wiedinmyer C, Hannigan MP, Oduro AR, Dickinson KL. Health impacts of a randomized biomass cookstove intervention in northern Ghana. BMC Public Health. 2021 Dec 4;21(1):2211. doi: 10.1186/s12889-021-12164-y.
    Results Reference
    derived

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