Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04633135
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2020-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There were 4 groups, 3 intervention and 1 control, all operating over the same period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2020-09-14', 'studyFirstSubmitQcDate': '2020-11-11', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health (Biomarkers of inflammation)', 'timeFrame': 'At baseline', '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).'}, {'measure': 'Health (Biomarkers of inflammation)', 'timeFrame': 'At 6 months', '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).'}, {'measure': 'Health (Biomarkers of inflammation)', 'timeFrame': 'At 12 months', '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).'}, {'measure': 'Health (Biomarkers of inflammation)', 'timeFrame': 'At 18 months', '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).'}, {'measure': 'Height', 'timeFrame': 'At baseline', 'description': 'Height of participants'}, {'measure': 'Height', 'timeFrame': 'At 6 months', 'description': 'Height of participants'}, {'measure': 'Height', 'timeFrame': 'At 12 months', 'description': 'Height of participants'}, {'measure': 'Height', 'timeFrame': 'At 18 months', 'description': 'Height of participants'}, {'measure': 'Weight', 'timeFrame': 'At baseline', 'description': 'Weight of participants'}, {'measure': 'Weight', 'timeFrame': 'At 6 months', 'description': 'Weight of participants'}, {'measure': 'Weight', 'timeFrame': 'At 12 months', 'description': 'Weight of participants'}, {'measure': 'Weight', 'timeFrame': 'At 18 months', 'description': 'Weight of participants'}, {'measure': 'Mid-arm circumference', 'timeFrame': 'At baseline', 'description': 'Measurement of mid-upper arm circumference of participants'}, {'measure': 'Mid-arm circumference', 'timeFrame': 'At 6 months', 'description': 'Measurement of mid-upper arm circumference of participants'}, {'measure': 'Mid-arm circumference', 'timeFrame': 'At 12 months', 'description': 'Measurement of mid-upper arm circumference of participants'}, {'measure': 'Mid-arm circumference', 'timeFrame': 'At 18 months', 'description': 'Measurement of mid-upper arm circumference of participants'}], 'secondaryOutcomes': [{'measure': 'Personal exposure to fine particulate matter (PM2.5)', 'timeFrame': '48 hour deployment periods', 'description': '48 hour integrated personal PM2.5 concentrations from filter measurements'}, {'measure': 'Personal exposure to carbon monoxide (CO)', 'timeFrame': '48 hour deployment periods', 'description': 'Daily average and integrated personal CO concentrations'}, {'measure': 'Kitchen area concentrations of carbon monoxide (CO)', 'timeFrame': '48 hour deployment periods', 'description': 'Daily average and integrated kitchen area CO concentrations'}, {'measure': 'Kitchen area concentrations of fine particulate matter (PM2.5)', 'timeFrame': '48 hour deployment periods', 'description': '48 hour integrated kitchen area PM2.5 concentrations from filter measurements'}, {'measure': 'Self-reported stove usage', 'timeFrame': 'At baseline', 'description': 'Surveys administered to respondents (primary cooks)'}, {'measure': 'Self-reported stove usage', 'timeFrame': 'At 6 months', 'description': 'Surveys administered to respondents (primary cooks)'}, {'measure': 'Self-reported stove usage', 'timeFrame': 'At 12 months', 'description': 'Surveys administered to respondents (primary cooks)'}, {'measure': 'Self-reported stove usage', 'timeFrame': 'At 18 months', 'description': 'Surveys administered to respondents (primary cooks)'}, {'measure': 'Stove usage as measured by devices', 'timeFrame': 'Throughout data collection period, approximately 2 years.', 'description': 'Continuous stove usage indicators as measured by temperature loggers on stoves'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Growth Retardation']}, 'referencesModule': {'references': [{'pmid': '25885780', 'type': 'BACKGROUND', '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.'}, {'pmid': '34863138', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '0 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion\n\nIndividual Participants:\n\n* Classified as "rural"\n* Uses biofuel as main cooking fuel source (firewood, animal waste, crop residue/sawdust)\n* Uses borehole as main water source (to facilitate social network analysis linking household\'s knowledge and attitudes toward stoves to experience of social contacts);\n* Does not have electricity (to permit possible addition of lighting intervention at a later date);\n* 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).\n\nClusters:\n\n* No more than 25% classified as urban\n* Accessible year-round (determined by field staff)\n* Having at least 10 eligible households (in line with the participant criteria above)\n\nExclusion:\n\n* Household could not be located\n* Household declined to participate'}, 'identificationModule': {'nctId': 'NCT04633135', 'acronym': 'REACCTING', 'briefTitle': 'Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'Research on Emissions, Air Quality, Climate and Cooking Technologies in Northern Ghana', 'orgStudyIdInfo': {'id': 'REACCTING'}, 'secondaryIdInfos': [{'id': 'GEO-1211668', 'type': 'OTHER_GRANT', 'domain': 'NSF'}, {'id': 'RD-8354201', 'type': 'OTHER_GRANT', 'domain': 'EPA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Households enrolled in the control arm of the study did not receive either improved cookstove'}, {'type': 'EXPERIMENTAL', 'label': 'Gyapa/Gyapa', 'description': 'Households enrolled in the Gyapa/Gyapa arm of the study received two Gyapa stoves for free', 'interventionNames': ['Device: Gyapa stove']}, {'type': 'EXPERIMENTAL', 'label': 'Gyapa/Philips', 'description': 'Households enrolled in the Gyapa/Philips arm of the study received one Gyapa stove and one Philips stove for free', 'interventionNames': ['Device: Philips stove', 'Device: Gyapa stove']}, {'type': 'EXPERIMENTAL', 'label': 'Philips/Philips', 'description': 'Households enrolled in the Philips/Philips arm of the study received two Philips stoves for free', 'interventionNames': ['Device: Philips stove']}], 'interventions': [{'name': 'Philips stove', 'type': 'DEVICE', 'otherNames': ['Gasifier stove'], 'description': 'Philips Smokeless stove HD4012LS', 'armGroupLabels': ['Gyapa/Philips', 'Philips/Philips']}, {'name': 'Gyapa stove', 'type': 'DEVICE', 'otherNames': ['Rocket stove'], 'description': 'Wood stove made in Ghana', 'armGroupLabels': ['Gyapa/Gyapa', 'Gyapa/Philips']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified data are available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'collaborators': [{'name': 'Environmental Protection Agency (EPA)', 'class': 'FED'}, {'name': 'U.S. National Science Foundation', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Michael Hannigan', 'investigatorAffiliation': 'University of Colorado, Boulder'}}}}